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

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Aerie Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Open Angle Glaucoma
Ocular Hypertension

Treatments

Other: Netarsudil Ophthalmic Solution Vehicle
Drug: Netarsudil ophthalmic solution 0.02%

Study type

Interventional

Funder types

Industry

Identifiers

NCT02874846
AR-13324-CS204

Details and patient eligibility

About

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

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

12 participants in 2 patient groups, including a placebo group

Netarsudil Ophthalmic Solution 0.02%
Experimental group
Description:
1 drop in each eye (OU) daily
Treatment:
Drug: Netarsudil ophthalmic solution 0.02%
Netarsudil Ophthalmic Solution Vehicle
Placebo Comparator group
Description:
1 drop in each eye (OU) daily
Treatment:
Other: Netarsudil Ophthalmic Solution Vehicle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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