NCT06960629

The Effect of ROCK Inhibitors on Corneas of Patients With Glaucoma and Pseudophakic Bullous Keratopathy (PBK)

The Effect of Topical Rho-kinase (ROCK) Inhibitors on Corneas of Patients With Glaucoma and Pseudophakic Bullous Keratopathy

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University Hospital Dubrava · Academic / Other
• Sex: All
• Age: 40 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if topical netarsudil/latanoprost works to treat pseudophakic bullous keratopathy in patients with glaucoma. The main questions it aims to answer are: Does topical netarsudil/latanoprost improves visual function in patients with glaucoma and pseudophakic bullous keratopathy? Does topical netarsudil/latanoprost affects the central corneal thickness (CCT) in patients with glaucoma and pseudophakic bullous keratopathy? Researchers will compare topical netarsudil/latanoprost to a placebo (a look-alike substance that contains no drug) to see if topical netarsudil/latanoprost works to treat pseudophakic bullous keratopathy (PBK). Participants will take topical netarsudil/latanoprost or a placebo every day for 3 months and visit the clinic once every two weeks for checkups and tests.

Detailed description

Patients with glaucoma and pseudophakic bullous keratopathy will be randomly divided in two groups. Group 1 will take topical netarsudil/latanoprost 1x daily for 3 months and group 2 will take topical placebo (artificial tear substitute) 1x daily for 3 months. Visual acuity (VA) will be evaluated using Snellen chart and converted to logarithm of the minimum angle of resolution (LogMAR). Central corneal thickness (CCT) measurements will be performed using ultrasound pacymetry (Micro Medical devices, Inc, CA). Information about adverse effects will be recorded during the study. Patients will visit every two weeks for checkups and measurements for 3 months.

Conditions

• Pseudophakic Bullous Keratopathy
• Glaucoma

Interventions

Type	Name	Description
DRUG	Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution	Patients with pseudophakic bullous keratopthy and glaucoma will receive topical netarsudil/latanoprost 1x daily for 3 months.
DRUG	Placebo	Patients with pseudophakic bullous keratopathy and glaucoma will receive topical placebo 8artificial tear substitute) 1x daily for 3 months.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-04-01
• Completion: 2026-10-01
• First posted: 2025-05-07
• Last updated: 2025-05-20

Locations

1 site across 1 country: Croatia

Regulatory

• FDA-regulated drug study