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

Aerie Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Corneal Edema

Treatments: Drug: Netarsudil Ophthalmic

Study type: Interventional

Funder types: Industry

Identifiers

NCT04498169

AR-13324-CS210

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults aged 18 years or older
2. Documented diagnosis of FCD
3. Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)
4. Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)

Exclusion criteria

1. FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period
2. Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
3. History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Once Daily Netarsudil Ophthalmic Solution

Experimental group

Description:

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.

Treatment:

Drug: Netarsudil Ophthalmic

Drug: Netarsudil Ophthalmic

Twice Daily Netarsudil Ophthalmic Solution

Experimental group

Description:

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.

Treatment:

Drug: Netarsudil Ophthalmic

Drug: Netarsudil Ophthalmic