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
• 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
• 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.

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Open Angle Glaucoma

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)