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

Phase 2

Completed

• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Interventions: Drug: Netarsudil ophthalmic solution 0.02%; Other: Netarsudil Ophthalmic Solution Vehicle

• Registration Number: NCT02874846
• Lead Sponsor: Aerie Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-22
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Disposition First Submitted: 2016-09-27
• Status Verified: 2016-10
• Disposition First Submitted QC: 2016-10-12
• Disposition First Posted: 2016-10-14
• Results First Submitted: 2018-01-23
• Results First Submitted QC: 2018-03-19
• Last Update Submitted: 2018-03-19
• Results First Posted: 2018-04-17
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Netarsudil Ophthalmic Solution 0.02%	Netarsudil ophthalmic solution 0.02%	1 drop in each eye (OU) daily
Netarsudil Ophthalmic Solution Vehicle	Netarsudil Ophthalmic Solution Vehicle	1 drop in each eye (OU) daily

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP) Over Nocturnal Time Period	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 Outcome Measures

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

Trial Locations

Locations (1)

Nancy Ramirez; 🇺🇸 Bedminster, New Jersey, United States