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NCT02874846 Clinical Trial

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

Ocular Hypertension Clinical Trial

Official title:
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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02874846
Other study ID # AR-13324-CS204
Secondary ID
Status Completed
Phase Phase 2
First received August 15, 2016
Last updated March 19, 2018
Start date July 2016
Est. completion date September 2016

Study information
Verified date October 2016
Source Aerie Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Nancy Ramirez Bedminster New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Intraocular Pressure (IOP) Over Nocturnal Time Period 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 Assessed over 24 hours at 9 pm, midnight, 3 am and 6 am on days 1/2 and 8/9
Secondary Number of Participants With Adverse Events as a Measure of Safety and Tolerability 7 days (day 1/2 to day 8/9)
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