XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS) (XEN GPS)

• ClinicalTrials.gov Identifier: NCT03654885
• Recruitment Status: Completed
• First Posted: August 31, 2018
• Results First Posted: July 21, 2022
• Last Update Posted: July 21, 2022
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

Brief Summary:

The purpose of this study is to compare the safety and efficacy of XEN-45 to trabeculectomy in participants with open angle glaucoma refractory to topical medical therapy.

Condition or disease	Intervention/treatment	Phase
Glaucoma	Device: XEN-45 Gel Stent; Procedure: Trabeculectomy	Phase 4

Detailed Description:

This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to evaluate the ability of XEN-45 to reduce intraocular pressure (IOP) and reduce the amount of topical IOP-lowering medications in participants poorly controlled on topical therapy. The planned study duration is 12 months. Participants were to be screened for enrollment and eligible candidates were to be approached to ascertain interest in study participation. Eligible participants were to be randomized 2:1; resulting in approximately 95 eyes implanted with XEN-45 and 44 eyes received trabeculetomy by study end.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)
• Actual Study Start Date: October 1, 2018
• Actual Primary Completion Date: May 13, 2021
• Actual Study Completion Date: May 13, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: XEN-45 Gel Stent; Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Device: XEN-45 Gel Stent; XEN-45 gel stent device implant
Active Comparator: Trabeculectomy; Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).	Procedure: Trabeculectomy; Trabeculectomy surgery

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats [ Time Frame: Baseline (Preoperative) to Month 12 ]
   IOP is a measure of the fluid pressure inside the eye. In addition to achieving a 20% reduction of IOP from Baseline, the participants had to meet all of the following prespecified caveats at Month 12: no increase in the number of topical IOP-lowering medications compared to Baseline, no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.

Secondary Outcome Measures :

1. Mean IOP Over Time [ Time Frame: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 ]
   IOP is a measurement of the fluid pressure inside the eye.
2. Change From Baseline in Mean IOP Over Time [ Time Frame: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 ]
   IOP is a measurement of the fluid pressure inside the eye.
3. Mean Number of Topical IOP-Lowering Medications Over Time [ Time Frame: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 ]
   IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
4. Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time [ Time Frame: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12 ]
   IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
5. Change From Baseline in Mean IOP at Month 12 [ Time Frame: Baseline (Preoperative) and Month 12 ]
   IOP is a measurement of the fluid pressure inside the eye.
6. Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12 [ Time Frame: Baseline (Preoperative) and Month 12 ]
   IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
7. Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg [ Time Frame: Baseline (Preoperative) and Month 12 ]
   IOP is a measurement of the fluid pressure inside the eye.
8. Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm Hg [ Time Frame: Baseline (Preoperative) and Month 12 ]
   Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
9. Percentage of Participants Achieving Specific IOP Targets at Month 12 [ Time Frame: Month 12 ]
   IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg.
10. Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 [ Time Frame: Baseline (Preoperative) to Month 12 ]
    IOP is a measurement of fluid pressure inside the eye. Specific percentage IOP lower targets included ≥25%, ≥30%, ≥35%, ≥40% ≥45%, and ≥50% IOP reduction.
11. Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 [ Time Frame: Baseline (Preoperative) and Month 12 ]
    IOP is a measurement of fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg.
12. Percentage of Participants With Needlings Performed [ Time Frame: Up to Month 12 ]
    Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye.
13. Mean Number of Needlings Per Eye [ Time Frame: Up to Month 12 ]
    Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye.
14. Percentage of Eyes Achieving at Least a 20% Reduction in IOP at Month 12 on the Same or Fewer Topical IOP-lowering Medications in Participants Who Had Needlings [ Time Frame: Month 12 ]
    IOP is a measurement of fluid pressure inside the eye. Topical IOP-lowering medication classes include: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
15. Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings [ Time Frame: Month 12 ]
    Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.
16. Percentage of Participants With Antifibrotic Use During Needling [ Time Frame: Up to Month 12 ]
    Antifibrotic use included mitomycin-C (MMC) which was standardized for both groups and administered according to physician training and practice.
17. Percentage of Participants Achieving Complete Success at Month 12 [ Time Frame: Month 12 ]
    Complete success was defined as IOP ≤18mm Hg, with 20% or greater IOP lowering from medicated Baseline, on no topical medications, and no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage.
18. Percentage of Participants Achieving Qualified Success at Month 12 [ Time Frame: Month12 ]
    Qualified success was defined as IOP ≤18 mm Hg, with 20% or greater IOP lowering from medicated Baseline, taking topical medications at Baseline Qualifying Visit, no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage.
19. Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye [ Time Frame: Month 12 ]
    IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12.
20. Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes [ Time Frame: Month 12 ]
    IOP is a measurement of the fluid pressure inside the eye. Specific percentage IOP lower targets included ≥25%, ≥30%, ≥35%, ≥40% ≥45%, and ≥50% IOP reduction. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12.
21. Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use [ Time Frame: Month 12 ]
    Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice.
22. Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration [ Time Frame: Month 12 ]
    Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The time of administration was classified into two categories as: Before Procedure and After Procedure.
23. Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy [ Time Frame: Month 12 ]
    Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The mode of administration was classified into two categories as: Injection and Other. Other includes all other modes of administration apart from injection.
24. Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy [ Time Frame: Month 12 ]
    Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The volume of administration measured in milliliters (mL) was classified into three categories as: 0.1, 0.2, and Other. Other includes all other volumes apart from 0.1 and 0.2.
25. Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy [ Time Frame: Month 12 ]
    Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The concentration of administration measured in milligram per milliliter (mg/mL) was classified into three categories as: 0.2, 0.4, and Other. Other includes all other concentrations apart from 0.2 and 0.4.
26. Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy [ Time Frame: Month 12 ]
    Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The absolute dose of administration measured in microgram per milliliter (µg/mL) was classified into two categories as: 40, and Other. Other includes all other concentrations apart from 40.
27. Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses [ Time Frame: Baseline and Day 1, Weeks 1 and 2, and Months 1, 3, 6, 9, and 12 ]
    BCVA was performed using a Snellen eye chart with glasses, and the BCVA data collected in the visual acuity electronic case report form (eCRF) page was analyzed. The number of lines read correctly was assessed as the line change from baseline at each follow-up evaluation and were log transformed. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower and negative logMAR value indicating better visual acuity.
28. Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale [ Time Frame: Baseline (Preoperative) and postoperative Months 1, 3, 6, and 12 ]
    Manifest Refraction - Mean Visual Acuity was performed using a Snellen eye chart with glasses. The line change from baseline at each follow-up evaluation in logarithm of the minimum angle of resolution (logMAR) was calculated. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.
29. Mean Surgically Induced Astigmatism - Autorefractor Reading [ Time Frame: Month 12 ]
30. Mean Change From Baseline in Surgically Induced Astigmatism - Autorefractor Reading [ Time Frame: Baseline (Preoperative) and Month 12 ]
31. Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites [ Time Frame: Baseline (Preoperative), Week 1, and Months 1 and 12 ]
32. Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth [ Time Frame: Baseline, Day 1 and Week 2 ]
33. Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D [ Time Frame: Baseline, Day 1 and Week 2 ]
    The keratometric values for keratometry (K) measured in 2 meridians (i.e., flat keratometry [K1] and steep keratometry [K2]) along with Delta (D) were determined.
34. Bleb Morphology - Anterior Segment Optical Coherence Tomography (AS-OCT) at Selected Sites [ Time Frame: Up to Month 12 ]
35. Bleb Morphology - Slit Lamp Photography at Selected Sites [ Time Frame: Up to Month 12 ]
36. Percentage of Participants With Clinical Hypotony [ Time Frame: Month 12 ]
    Clinical hypotony was defined as vision reduction (2 lines or more) related to macular changes consistent with hypotony maculopathy (macular folds), optic disc edema, and/or serous choroidal detachments because of low IOP.
37. Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment [ Time Frame: Up to Month 12 ]
    Eyes with IOP 6 mm Hg or less at any time point and relevant clinical assessment (vision reduction [2 lines or more] related to macular changes consistent with hypotony maculopathy [macular folds], optic disc edema, anterior chamber status, and/or serous choroidal detachments because of low IOP) of these eyes at those time points were assessed. Only data from study eyes are included. The worse eye was selected as the study eye if both eyes met the inclusion criteria. The worse eye was defined using the visual field MD at Baseline, with the worse eye having the most negative MD. In cases where the MD was the same in both eyes to two decimal places, the worse eye was defined as the eye with the higher IOP.
38. Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) [ Time Frame: Median follow-up of 366.0 days ]
    An adverse event(AE)is any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. Intraoperative AESIs included- Detached Descemet's membrane,iris damage,lens contact,vitreous bulge or loss,anterior chamber bleeding,retrobulbar hemorrhage,conjunctival perforation,conjunctival or scleral flap tearing,shallow anterior chamber with peripheral iridocorneal touch,flat anterior chamber with iridocorneal touch extending to the pupil,device malfunction identified prior to implantation,and choroidal hemorrhage of effusion. Only categories with at least one participant with event in the study eye are reported. The worse eye was selected as the study eye if both eyes met inclusion criteria. The worse eye was defined using visual field MD at Baseline, with the worse eye having the most negative MD. If MD was same in both eyes to two decimal places, the worse eye=eye with higher IOP.
39. Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs) [ Time Frame: Median follow-up of 366.0 days ]
    AE=any untoward medical occurrence in a clinical investigation participant administered drug;it does not necessarily have to have a causal relationship with the treatment. TEAE is an AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Postoperative AEs included but were not limited to: angle recession, anterior chamber changes, BCVA loss,bleb leak, blebitis, cataract, choroidal effusion, chronic pain, corneal edema, cyclodialysis, Dellen, device malfunction, endophthalmitis, fixed dilated pupil, hyphema, hypotony, implant issues, increase in corneal thickness/IOP, explant, iridodialysis, iritis, loss of eye, etc.Worse eye=eye if both eyes met inclusion criteria. Worse eye was defined using visual field MD at Baseline, with worse eye having the most negative MD. In cases where MD was the same in both eyes to two decimal places, worse eye was defined as eye with higher IOP.
40. Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up [ Time Frame: Baseline up to Month 12 ]
    The categories = Worsening (<-2), No Change (≥-2 and ≥2), Improving (>2) and Missing were used for determining BCVA worst line change from Baseline. Only categories with at least one participant with event are reported.
41. Pachymetry Based on Change From Baseline In Average Central Corneal Thickness [ Time Frame: Baseline (Preoperative) and Month 12 ]
    Pachymetry was measured as average central corneal thickness (microns/micrometer) change from Baseline.
42. Change From Baseline in Visual Field Examinations Analyzed by Machine Type [ Time Frame: Baseline and Month 12 ]
    All visual field examination data were collected and reported as mean deviation by Humphrey machine.
43. Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) [ Time Frame: Median follow-up of 366.0 days ]
    AE=any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. An SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. ADEs and SADEs are AEs and SAEs that are caused by the device
44. Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores [ Time Frame: Baseline (Preoperative) to Month 6 ]
    The SHPC-18 is an 18-item questionnaire that asks participants being treated for glaucoma questions about eye symptoms or problems they may experience. There are two domains: Local Eye Symptoms (7 items) subscale score 0 to 700 divided by 7 and Visual Function Problem (11 items) subscale score 0 to 1100 divided by 11. The scores of each subscale ranges from from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A frequency score was calculated by summing the individual response scores of each item, and ranges from 0 to 7 for Local Eye Symptom and from 0 to 11 for Visual Function. A total bothersome score for the SHPC-18 is calculated by summing all 18 items scores, resulting in a range from 0 to 1800, then dividing the sum by 18, to create a total bothersome score ranging from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A negative change from Baseline for all scales and subscales indicates improvement.
45. PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine [ Time Frame: Month 3 ]
    Participants answered the question, "Since your glaucoma surgery, would you consider that you have resumed your usual activities and daily routine?" using the following categories: Not at all, Somewhat, Moderately so, Mostly, Completely.
46. PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health [ Time Frame: Baseline (Preoperative) and Month 12 ]
    WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.
47. PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health [ Time Frame: Baseline (Preoperative) and Month 12 ]
    WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Open-angle glaucoma where the intraocular pressure (IOP) is not controlled when using topical IOP-lowering glaucoma medication
• Best-corrected baseline Snellen visual acuity of 20/100 or better
• Visual field mean deviation no worse than -18.0 decibels (dB)
• Medicated IOP ≥15 millimeter of mercury (mm Hg) and ≤44 mm Hg
• Participants not anticipated to require any ocular surgery (e.g., cataract surgery) in either eye up to 3 months from the time of inclusion
• Area of healthy, free, and mobile conjunctiva in the target area (superior bulbar conjunctiva)
• Trabecular meshwork must be visible (with Shaffer angle grade ≥2 in the target quadrant)
• Failed ab-interno canal or suprachoroidal micro invasive glaucoma surgery (MIGS) procedures (such as i-Stent, gonioscopy-assisted transluminal trabeculotomy [GATT], Ab-interno canaloplasty [ABiC], Kahook dual blade goniotomy, etc.) are allowed ≥3 months before enrollment. CyPass® Micro-Stents were not allowed.

Exclusion Criteria:

• Participant has active neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
• Participant has had prior ab externo incisional glaucoma surgery (such as trabeculectomy, viscocanalostomy, canaloplasty, tube shunts of any type, collagen implants, etc.), conjunctival filtering surgery, transscleral cycloablative procedures (such as cyclophotocoagulation, micro pulse cyclophotocoagulation, cryotherapy, ultrasound circular cyclocoagulation [UC3], etc.) or prior major conjunctival surgery (i.e., scleral buckle)
• Clinically significant inflammation or infection within 30 days before the preoperative visit (e.g., blepharitis, conjunctivitis, severe ocular surface disease, keratitis, uveitis, herpes simplex infection)
• Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target area
• History of corneal surgery, corneal opacities, or corneal disease
• Central corneal thickness ≤490 micrometer (μm) or ≥620μm
• Vitreous present in the anterior chamber
• Aphakic
• Participant has had prior intraocular surgery in either eye within ≤3 months before the preoperative visit (including phacoemulsification)
• History of complicated cataract surgery (e.g. with visual impairment, e.g. vitreous loss, anterior chamber intraocular lens [ACIOL], perhaps sutured intraocular lens [IOL] or scleral fixated IOL, prior cystoid macular edema [CME], etc.)
• Presence of intraocular silicone oil
• Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization, branch retinal vein occlusion, central retinal vein occlusion, geographic atrophy, or other ophthalmic disease or disorder that could confound study results or impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos, Axenfeld-Reiger, iridocorneal endothelial syndrome [ICE], etc.)
• Known or suspected allergy or sensitivity to drugs required for the protocol (including anesthesia), or any of the device components (e.g., bovine or porcine products, or glutaraldehyde)
• Pregnant or nursing women and those planning a pregnancy during the study period.
• Participation in another drug or device clinical trial concluding within 30 days before the preoperative visit

Contacts and Locations

Locations

United States, Arkansas

Vold Vision /ID# 233677

Fayetteville, Arkansas, United States, 72704

United States, California

Retina Institute of California /ID# 233692

Arcadia, California, United States, 91007

Angeles Eye Institute /ID# 233632

Culver City, California, United States, 90232

Cha Medical Group Pc /Id# 233649

Los Angeles, California, United States, 90027

Grutzmacher Lewis and Sierra Inc. /ID# 233654

Sacramento, California, United States, 95815

United States, Colorado

University of Colorado Denver /ID# 233676

Denver, Colorado, United States, 80291-0238

United States, District of Columbia

Howard University Hospital /ID# 233615

Washington, District of Columbia, United States, 20060

United States, Florida

Eye Surgery Associates /ID# 233638

Hollywood, Florida, United States, 33020

Specialty Retina Center /ID# 233628

Weston, Florida, United States, 33326

United States, Georgia

Georgia Eye Partners /ID# 233655

Atlanta, Georgia, United States, 30342

Coastal Research Associates /ID# 233575

Roswell, Georgia, United States, 30076

United States, Hawaii

Tyrie Lee Jenkins MD Inc. /ID# 233674

Honolulu, Hawaii, United States, 96814

United States, Illinois

Illinois Eye Center /ID# 233631

Peoria, Illinois, United States, 61615

United States, Kansas

Stiles Eyecare Excellence /ID# 233583

Overland Park, Kansas, United States, 66213

United States, Massachusetts

Advanced Glaucoma Specialists /ID# 233690

Reading, Massachusetts, United States, 01867

United States, Michigan

Kellogg Eye Center University of Michigan health system /ID# 233651

Ann Arbor, Michigan, United States, 48105

United States, Minnesota

Mayo Clinic Jacksonville /ID# 233634

Saint Paul, Minnesota, United States, 55108

United States, Missouri

Washington University in St. Louis /ID# 233599

Saint Louis, Missouri, United States, 63110

United States, New York

Glaucoma associates/consultants of the capital region /ID# 233695

Slingerlands, New York, United States, 12159

United States, North Carolina

Carolina Eye Associates /ID# 233656

Southern Pines, North Carolina, United States, 28387

United States, Ohio

Eye Care Associates Inc /ID# 233636

Youngstown, Ohio, United States, 44502

United States, Oklahoma

Dean McGee Eye Institute /ID# 233595

Oklahoma City, Oklahoma, United States, 73104

United States, Pennsylvania

Ludwick Eye Center /ID# 233691

Chambersburg, Pennsylvania, United States, 17201

Kremer Eye Center /Id# 233642

King Of Prussia, Pennsylvania, United States, 19406

Wills Eye Institute /ID# 233645

Philadelphia, Pennsylvania, United States, 19107

university of Pittsburgh /ID# 233622

Pittsburgh, Pennsylvania, United States, 15213

United States, South Carolina

Carolinas Centers for Sight,PC /ID# 233606

Florence, South Carolina, United States, 29501

United States, Tennessee

Nashville Vision Associates /ID# 233644

Nashville, Tennessee, United States, 37205

United States, Texas

Glaucoma Associates of Texas /ID# 233587

Dallas, Texas, United States, 75231

El Paso Eye Surgeons, P.A. /ID# 233584

El Paso, Texas, United States, 79902

Houston Eye Associates /ID# 233621

Houston, Texas, United States, 77025

Baylor College of Medicine - Baylor Medical Center /ID# 233612

Houston, Texas, United States, 77030-3411

United States, Virginia

Vistar Eye Center /ID# 233652

Roanoke, Virginia, United States, 24011

United States, Wisconsin

SSM Health Dean Medical Group /ID# 233624

Madison, Wisconsin, United States, 53715

The Eye Centers of Racine and Kenosha LTD /ID# 233657

Racine, Wisconsin, United States, 53405

Sponsors and Collaborators

Allergan

Investigators

• Study Director: ALLERGAN INC.; Allergan

  Study Documents (Full-Text)

Documents provided by Allergan:

Study Protocol  [PDF] March 21, 2019

Statistical Analysis Plan  [PDF] May 13, 2021

More Information

Additional Information:

Related Info 

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT03654885
• Other Study ID Numbers: CMO-US-EYE-0600
• First Posted: August 31, 2018
• Results First Posted: July 21, 2022
• Last Update Posted: July 21, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• URL: https://vivli.org/ourmember/abbvie/

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Glaucoma; Ocular Hypertension; Eye Diseases