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

• Conditions: Pseudophakic Bullous Keratopathy; Glaucoma
• Interventions: Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution; Drug: Placebo

• Registration Number: NCT06960629
• Lead Sponsor: University Hospital Dubrava

Brief 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.

Study Timeline

• Study Start: 2025-04-01
• Study First Submitted: 2025-04-28
• Study First Submitted QC: 2025-04-28
• Status Verified: 2025-05
• Study First Posted: 2025-05-07
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-04-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• both sex,
• age between 40 and 90 years
• pseudophakic bullous keratopathy
• glaucoma

Exclusion Criteria

• other anterior segment pathology (corneal opacities);
• ocular surface inflammation
• retinal diseases affecting visual acuity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rock inhibitor group	Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution	Group 1 or ROCK inhibitor group will receive topical netarsudil/latanoprost 1x daily for 3 months.
Placebo group	Placebo	Placebo group will receive topical placebo (artificial tear substitute) 1x daily for 3 months.

Primary Outcome Measures

Name	Time	Method
Visual acuity (VA)	3 months	Visual acuity measurements using Snellen chart and converted to logMAR

Secondary Outcome Measures

Name	Time	Method
Central corneal thickness (CCT)	3 months	CCT will be measured using ultrasound pachymetry.

Trial Locations

Locations (1)

University Hospital Dubrava; 🇭🇷 Zagreb, Croatia