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OpenTrials
Completed

NCT Number: NCT02874846

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

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

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Key information

Conditions

Ocular Hypertension Eye Diseases Glaucoma Glaucoma, Open-Angle Open Angle Glaucoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nancy Ramirez

Bedminster, New Jersey, 07921, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older.
  • Ocular hypertension or open-angle glaucoma in both eyes.
  • Unmedicated intraocular pressure > 17 mmHg in one or both eyes and < 30 mmHg in both eyes.
  • Corrected visual acuity in each eye equivalent to 20/200 or better.
  • Able and willing to give signed informed consent and follow study instructions.

Exclusion criteria

  • Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles.
  • Intraocular pressure ≥ 30 mmHg.
  • Use of ocular medications within 30 days.
  • Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination.
  • Previous eye surgery (other than cataract).
  • Ocular trauma within 6 months.
  • Clinically significant ocular disease that might interfere with the study.
  • Central corneal thickness greater than 620 µm.

Treatment and study plan

Netarsudil ophthalmic solution 0.02%

Drug

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

Other names: AR-13324

Netarsudil Ophthalmic Solution Vehicle

Other

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

Primary outcomes

  1. 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 outcomes

  1. Number of Participants With Adverse Events as a Measure of Safety and Tolerability

    Time frame: 7 days (day 1/2 to day 8/9)

Sponsors and collaborators

Lead sponsor

Aerie Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 22, 2016
Registry last updated
Apr 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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