Trial of Netarsudil for Acceleration of Corneal Endothelial Restoration

Price Vision Group

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Fuchs' Endothelial Dystrophy

Treatments: Drug: Netarsudil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03971357

2018-009

Details and patient eligibility

About

Subjects with Fuchs dystrophy will be randomized to use either netarsudil or placebo eye drops to determine if the use of netarsudil accelerates migration of host peripheral corneal endothelial cells to restore the central endothelial cell layer.

Full description

Subjects with Fuchs endothelial dystrophy will have the central corneal endothelium and guttae-covered Descemet membrane surgically removed. Subjects will be randomized to use netarsudil or placebo eye drops once daily. Visual acuity, corneal clearing and central endothelial cell density will be monitored for the 3-month study duration.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient at least 18 years of age and of any race or ethnicity who is undergoing Descemet stripping only for Fuchs dystrophy
• Is able and willing to administer eye drops
• Is able to comprehend and has signed the Informed Consent form.

Exclusion criteria

• Active intraocular inflammation
• Corneal ulceration, keratitis, or conjunctivitis
• Known sensitivity to any of the ingredients in the study medications
• Abnormal eyelid function
• History of herpetic keratitis
• History of non-compliance with using prescribed medication
• Current or planned pregnancy within the study duration
• Concurrent involvement or participation in another randomized clinical trial within 30 days prior to enrollment in this study
• Any ocular or systemic condition (i.e., UNCONTROLLED systemic disease) or situation which in the investigator's opinion may put the patient at significant risk, confound the study results, or interfere significantly with the patient's participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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19 participants in 2 patient groups, including a placebo group

Netarsudil

Experimental group

Description:

Netarsudil ophthalmic solution 0.02%, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner

Treatment:

Drug: Netarsudil

Placebo

Placebo Comparator group

Description:

Placebo eye drop, dosed topically daily for the 3-month study duration or until 2 weeks after corneal clearing is complete, whichever occurs sooner.

Treatment:

Drug: Placebo