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Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03233308
Recruitment Status : Completed
First Posted : July 28, 2017
Results First Posted : June 11, 2019
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 12, 2017
First Posted Date  ICMJE July 28, 2017
Results First Submitted Date  ICMJE April 18, 2019
Results First Posted Date  ICMJE June 11, 2019
Last Update Posted Date August 6, 2019
Actual Study Start Date  ICMJE October 20, 2017
Actual Primary Completion Date April 19, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility [ Time Frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8 ]
    Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
  • Mean Percent Change From Baseline in the Mean Diurnal Trabecular Outflow Facility. [ Time Frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8 ]
    Mean diurnal change from baseline in trabecular (tonographic) outflow facility.
Original Primary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
Mean Change From Baseline in the Mean Diurnal Trabecular Outflow Facility [ Time Frame: 7 days ]
Change History Complete list of historical versions of study NCT03233308 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Mean Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP) [ Time Frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8 ]
    Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)
  • Mean Percent Change From Baseline in Episcleral Venous Pressure (EVP) and in Intraocular Pressure (IOP) [ Time Frame: Study treatment was administered for 7 days, and outcome measures collected on Day 8 ]
    Mean diurnal change from baseline in mean diurnal IOP measured using a Pneumatonometer and mean diurnal EVP using a custom-modified slit-lamp mounted venomanometer. (EVP conducted at a single site in only 9 participants)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2017)
  • Mean change from baseline in the mean intraocular pressure [ Time Frame: 7 days ]
  • Mean change from baseline in the mean episcleral venous pressure [ Time Frame: 7 days ]
  • All treatment-emergent AEs that occurs or worsens on or after the first treatment [ Time Frame: 7 days ]
  • Observed and change from baseline in visual acuity [ Time Frame: 7 days ]
  • Evaluation of anterior segment by slit-lamp biomicroscopy from baseline [ Time Frame: 7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Netarsudil Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)
Official Title  ICMJE A Double-Masked, Randomized, Placebo-Controlled Study of Trabecular Outflow Facility Following Treatment With Netarsudil Ophthalmic Solution 0.02% (AR-13324) in Subjects With Elevated Intraocular Pressure
Brief Summary To evaluate the effect on trabecular outflow facility of Netarsudil ophthalmic solution 0.02% compared to placebo
Detailed Description Trabecular outflow facility is a measure of aqueous humor dynamics; effect of netarsudil on this parameter as well as on intraocular pressure and episcleral venous pressure was evaluated in this study. Netarsudil treatment was given in one eye and placebo given in contralateral eye for 7 consecutive days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Paired comparison study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Primary Open Angle Glaucoma or Ocular Hypertension
Intervention  ICMJE
  • Drug: Netarsudil Ophthalmic Solution 0.02%
    1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye
  • Other: Placebo Comparator
    1 drop daily (QD), in the morning (AM) of Placebo comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye
Study Arms  ICMJE
  • Experimental: Netarsudil Ophthalmic Solution 0.02%
    Netarsudil Ophthalmic Solution 0.02% was administered in one eye and Placebo comparator in contralateral eye
    Interventions:
    • Drug: Netarsudil Ophthalmic Solution 0.02%
    • Other: Placebo Comparator
  • Placebo Comparator: Placebo Comparator
    Placebo comparator administered in one eye and Netarsudil Ophthalmic Solution 0.02% in contralateral eye
    Interventions:
    • Drug: Netarsudil Ophthalmic Solution 0.02%
    • Other: Placebo Comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 19, 2018
Actual Primary Completion Date April 19, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Must be 18 years of age or older
  2. Diagnosis of open primary angle glaucoma(POAG) or ocular hypertension (OHT) in both eyes
  3. Unmedicated intraocular pressure (IOP) >20 mmHg and < 30 mmHg in both eyes at first qualification visit
  4. Best corrected visual acuity (BCVA) equivalent to 20/200 Snellen or better
  5. Able to give informed consent and follow study instructions

Exclusion Criteria:

Ophthalmic:

  1. Clinically significant ocular disease
  2. Pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure glaucoma, or narrow angles
  3. Intraocular pressure ≥30 mmHg in either eye
  4. A difference in IOP between eyes >4mmHg at qualification visit
  5. Use of more than two ocular hypotensive medications within 30 days of screening
  6. Known hypersensitivity to any component of the formulation
  7. Previous glaucoma surgery or refractive surgery
  8. Keratorefractive surgery in either eye
  9. Report of ocular injury in either eye within the six months prior to screening or ocular or non-refractive surgery within 3 months prior to screening
  10. Recent or current ocular infection or inflammation in either eye
  11. Use of ocular medication in either eye of any kind within 30 days of screening
  12. Mean central corneal thickness greater than 620 μm in either eye
  13. Any abnormality preventing reliable applanation tonometry of either eye
  14. Lack of suitable episcleral vein prior to performing Episcleral Venus Pressure (EVP) measurement (applicable to 1 site only)

    Systemic:

  15. Clinically significant abnormalities within 6 weeks prior to screening
  16. Clinically significant systemic disease
  17. Participation in any investigational study within 60 days prior to screening
  18. Use of systemic medication that could have an effect on intraocular pressure within 30 days prior to screening
  19. Women of childbearing potential who were pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03233308
Other Study ID Numbers  ICMJE AR-13324-CS206
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aerie Pharmaceuticals
Study Sponsor  ICMJE Aerie Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nancy Ramirez-Davis Aerie Pharmaceuticals
PRS Account Aerie Pharmaceuticals
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP