Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution

Overview

To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.

Full Title of Study: “A Double-masked, Randomized, Placebo-controlled Study of the Nocturnal and Diurnal IOP-lowering Effect of Netarsudil Ophthalmic Solution 0.02% in Habitual Positions Over a 24-hour Period.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2016

Interventions

  • Drug: Netarsudil ophthalmic solution 0.02%
    • Once daily in both eyes (OU) in the evening (PM) for 7 days
  • Other: Netarsudil Ophthalmic Solution Vehicle
    • Once daily in both eyes (OU) in the evening (PM) for 7 days

Arms, Groups and Cohorts

  • Experimental: Netarsudil Ophthalmic Solution 0.02%
    • 1 drop in each eye (OU) daily
  • Placebo Comparator: Netarsudil Ophthalmic Solution Vehicle
    • 1 drop in each eye (OU) daily

Clinical Trial Outcome Measures

Primary Measures

  • Change in Intraocular Pressure (IOP) Over Nocturnal Time Period
    • Time Frame: Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9
    • The primary efficacy endpoint was the mean change from baseline in mean nocturnal IOP (defined as the mean of the 4 nocturnal time points: 21:00, 00:00, 03:00, and 06:00 hours) on Day 8/Day 9

Secondary Measures

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability
    • Time Frame: 7 days (day 1/2 to day 8/9)

Participating in This Clinical Trial

Inclusion Criteria

1. 18 years of age or older.

2. Ocular hypertension or open-angle glaucoma in both eyes.

3. Unmedicated intraocular pressure > 17 mmHg in one or both eyes and < 30 mmHg in both eyes.

4. Corrected visual acuity in each eye equivalent to 20/200 or better.

5. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria

1. Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles.

2. Intraocular pressure ≥ 30 mmHg.

3. Use of ocular medications within 30 days.

4. Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination.

5. Previous eye surgery (other than cataract).

6. Ocular trauma within 6 months.

7. Clinically significant ocular disease that might interfere with the study.

8. Central corneal thickness greater than 620 µm.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aerie Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Theresa Heah, MD, Study Director, Aerie Pharmaceuticals

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.