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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Ocular Hypertension Open Angle Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Netarsudil Ophthalmic Solution 0.02%

1 drop in each eye (OU) daily

Group Type EXPERIMENTAL

Netarsudil ophthalmic solution 0.02%

Intervention Type DRUG

Once daily in both eyes (OU) in the evening (PM) for 7 days

Netarsudil Ophthalmic Solution Vehicle

1 drop in each eye (OU) daily

Group Type PLACEBO_COMPARATOR

Netarsudil Ophthalmic Solution Vehicle

Intervention Type OTHER

Once daily in both eyes (OU) in the evening (PM) for 7 days

Interventions

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Netarsudil ophthalmic solution 0.02%

Once daily in both eyes (OU) in the evening (PM) for 7 days

Intervention Type DRUG

Netarsudil Ophthalmic Solution Vehicle

Once daily in both eyes (OU) in the evening (PM) for 7 days

Intervention Type OTHER

Other Intervention Names

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AR-13324

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No