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A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery

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ClinicalTrials.gov Identifier: NCT04089735
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Formosa Pharmaceuticals, Inc.

Brief Summary:
This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose strength and dosing frequency in a randomized double-masked fashion for comparison to the respective matching vehicle placebo. Part A will be conducted first to evaluate 0.05% APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42 subjects who experience postoperative inflammation on the first day following routine, uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1% APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1 ratio, active vs. placebo. In each Part, subjects will return periodically for study assessments during the treatment period and then for a follow-up visit approximately 1 week after stopping the study drug.

Condition or disease Intervention/treatment Phase
Ocular Inflammation and Pain Drug: APP13007, 0.05% Drug: APP13007, 0.1% Drug: APP13007 Placebo, 0.05% Drug: APP13007 Placebo, 0.1% Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Masked, Two-Part, Placebo-Controlled Phase 2A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 for the Treatment of Inflammation and Pain After Cataract Surgery
Actual Study Start Date : August 13, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: APP13007 0.05% BID
1 drop 0.05% APP13007 twice daily for 21 days to the operated eye
Drug: APP13007, 0.05%
APP13007 eye drop, 0.05%

Experimental: APP13007 0.05% Placebo BID
1 drop matching vehicle placebo for 0.05% APP13007 twice daily for 21 days to the operated eye
Drug: APP13007 Placebo, 0.05%
APP13007 eye drop, placebo 0.05%

Experimental: APP13007 0.05% BID/QD
1 drop 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye
Drug: APP13007, 0.05%
APP13007 eye drop, 0.05%

Experimental: APP13007 0.05% Placebo BID/QD
1 drop matching vehicle placebo for 0.05% APP13007 twice daily followed by 1 drop once daily to the operated eye
Drug: APP13007 Placebo, 0.05%
APP13007 eye drop, placebo 0.05%

Experimental: APP13007 0.1% BID/QD
1 drop 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye
Drug: APP13007, 0.1%
APP13007 eye drop, 0.1%

Experimental: APP13007 0.1% Placebo BID/QD
1 drop matching vehicle placebo for 0.1% APP13007 twice daily followed by 1 drop once daily to the operated eye
Drug: APP13007 Placebo, 0.1%
APP13007 eye drop, placebo 0.1%




Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Post-operative Day 28 ]
    Incidence of treatment emergent adverse events at each study visit.

  2. Ocular Anatomy [ Time Frame: Post-operative Day 28 ]
    Ocular anatomy is routinely assessed using slit-lamp biomicroscopy and dilated indirect ophthalmoscopy. Ocular tissues are examined at each study visit and any anatomical abnormalities are recorded using standard medical descriptive terminology.

  3. Intraocular Pressure [ Time Frame: Post-operative Day 28 ]
    Intraocular pressure is measured in mm Hg at each study visit with a Goldmann applanation tonometer. The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.

  4. Laboratory Blood Chemistry Parameters [ Time Frame: Post-operative Day 28 ]
    Laboratory chemistry parameters are measured using automated equipment that is used routinely in clinical practice for the measurement of blood electrolytes, proteins, hormones and metabolites and results are reported using standard biochemical units.

  5. Laboratory Blood Hematology Parameters [ Time Frame: Post-operative Day 28 ]
    Laboratory hematology parameters are measured using automated equipment that is used routinely in clinical practice for the measurement of blood cells and hemoglobin and results are reported using standard hematological units.

  6. Absolute Anterior Chamber Cell Count [ Time Frame: Post-operative Day 28 ]
    The number of cells in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit and the results are reported as number of cells in a 1mm x 1mm area.

  7. Visual Acuity [ Time Frame: Post-operative Day 28 ]
    The visual acuity in each eye is corrected using the pinhole method and the acuity is quantified on a logMAR (minimal angle of resolution) scale using the 'Early Treatment Diabetic Retinopathy Study' [ETDRS] charts for right and left eyes.

  8. Ocular Pain Grade [ Time Frame: Post-operative Day 28 ]
    Ocular pain is measured in each eye using a subject-reported five-point (0-4) ocular pain grade scale (0 = no pain; 4 = severe pain).


Secondary Outcome Measures :
  1. Change from Baseline of Anterior Chamber Cell Count [ Time Frame: Post-operative Day 28 ]
    The number of cells in a 1mm x 1mm area in the anterior chamber of the eye are counted using slit-lamp biomicroscopy at each study visit. The change from baseline is calculated by subtracting the pretreatment measurement from the value at each visit.

  2. Anterior Chamber Flare [ Time Frame: Post-operative Day 28 ]
    The degree of turbidity (flare) in the anterior chamber of the eye is measured using slit-lamp biomicroscopy and quantified on a five-point (0-4) anterior chamber flare grade scale (0 = none; 4 = Intense). The change from baseline is calculated by subtracting the pretreatment measurement value from the value at each visit.

  3. Use of Anti-inflammatory 'Rescue' Medication [ Time Frame: Post-operative Day 28 ]
    Subjects who do not respond to study treatment after randomization (anterior chamber cell count > 30 cells or an increase in anterior chamber cell count by > 15 cells from pre-dose baseline or ≥ 2 grade of increase in anterior chamber flare from pre-dose baseline) are started on anti-inflammatory medication (referred to as 'Rescue' medication). The number of subjects starting 'Rescue' medication are recorded at each study visit.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Expected to undergo unilateral uncomplicated cataract extraction via phacoemulsification and posterior chamber intraocular lens implantation in one eye.
  • In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated potential of 0.7 (20/100) or better in study eye.
  • Have > 10 and ≤ 30 cells in anterior chamber.
  • Have an intraocular pressure ≤ 30 mmHg.

Exclusion Criteria:

  • Have an anterior chamber cell count > 0 or any evidence of intraocular inflammation.
  • Have a score > 0 on Ocular Pain Assessment in either eye.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04089735


Contacts
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Contact: Clinical Ops Representative 919-797-1146 Clin.Ops@aimmaxrx.com

Locations
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United States, Arizona
Cornea and Cataract Consultants of Arizona Recruiting
Phoenix, Arizona, United States, 85032
Contact: Study Coordinator         
Principal Investigator: Gross         
United States, California
United Medical Research Institute Recruiting
Inglewood, California, United States, 90301
Contact: Study Coordinator         
Principal Investigator: Peace         
Martel Eye Medical Group Recruiting
Rancho Cordova, California, United States, 95670
Contact: Study Coordinator         
Principal Investigator: Martel         
United States, Florida
Levenson Eye Associates Recruiting
Jacksonville, Florida, United States, 32204
Contact: Study Coordinator         
Principal Investigator: Levenson         
United States, Missouri
Ophthalmology Associates Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Study Coordinator         
Principal Investigator: Malhotra         
United States, Pennsylvania
Eye Care Specialists Recruiting
Kingston, Pennsylvania, United States, 18704
Contact: Study Coordinator         
Principal Investigator: Reiser         
United States, Texas
Keystone Research Ltd. Recruiting
Austin, Texas, United States, 78731
Contact: Study Coordinator         
Principal Investigator: Walters         
Cataract & Glaucoma Center Recruiting
El Paso, Texas, United States, 79902
Contact: Study Coordinator         
Principal Investigator: Alpern         
Sponsors and Collaborators
Formosa Pharmaceuticals, Inc.

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Responsible Party: Formosa Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04089735     History of Changes
Other Study ID Numbers: CPN-201
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Capsule Opacification
Inflammation
Pathologic Processes
Lens Diseases
Eye Diseases