A Phase 2 Study Evaluating the Safety and Efficacy of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy

Conditions

• Corneal Edema

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Netarsudil Ophthalmic — DRUG
  Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
• Netarsudil Ophthalmic — DRUG
  Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution

Study Details

Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.

Key Dates

Start date

Sep 17, 2020

Status verified

Aug 2022

Primary completion

Aug 11, 2021

Completion

Aug 11, 2021

Study Design

Enrollment

40 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Once Daily Netarsudil Ophthalmic Solution
  One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.
• Experimental: Twice Daily Netarsudil Ophthalmic Solution
  One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.

Primary Outcome Measure

Central Corneal Thickness (CCT) [ Time Frame: Baseline & 4 weeks ]

Locations (12)

Find similar trials in Garden Grove, CA

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