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Trial record 2 of 19 for:    netarsudil

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

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ClinicalTrials.gov Identifier: NCT02874846
Recruitment Status : Completed
First Posted : August 22, 2016
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Aerie Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Ocular Hypertension Open Angle Glaucoma Drug: Netarsudil ophthalmic solution 0.02% Other: Netarsudil Ophthalmic Solution Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : July 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
Experimental: Netarsudil Ophthalmic Solution 0.02%
1 drop in each eye (OU) daily
Drug: Netarsudil ophthalmic solution 0.02%
Once daily in both eyes (OU) in the evening (PM) for 7 days
Other Name: AR-13324

Placebo Comparator: Netarsudil Ophthalmic Solution Vehicle
1 drop in each eye (OU) daily
Other: Netarsudil Ophthalmic Solution Vehicle
Once daily in both eyes (OU) in the evening (PM) for 7 days




Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02874846


Locations
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United States, New Jersey
Nancy Ramirez
Bedminster, New Jersey, United States, 07921
Sponsors and Collaborators
Aerie Pharmaceuticals
Investigators
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Study Director: Theresa Heah, MD Aerie Pharmaceuticals

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Responsible Party: Aerie Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02874846     History of Changes
Other Study ID Numbers: AR-13324-CS204
First Posted: August 22, 2016    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Ocular Hypertension
Glaucoma
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions