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

NCT ID: NCT06960629

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-10-01

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.

Conditions

Pseudophakic Bullous Keratopathy; Glaucoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Rock inhibitor group

Group 1 or ROCK inhibitor group will receive topical netarsudil/latanoprost 1x daily for 3 months.

Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution

Intervention Type: DRUG

Patients with pseudophakic bullous keratopthy and glaucoma will receive topical netarsudil/latanoprost 1x daily for 3 months.

Placebo group

Placebo group will receive topical placebo (artificial tear substitute) 1x daily for 3 months.

Placebo

Intervention Type: DRUG

Patients with pseudophakic bullous keratopathy and glaucoma will receive topical placebo 8artificial tear substitute) 1x daily for 3 months.

Interventions

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.

Intervention Type: DRUG

Placebo

Patients with pseudophakic bullous keratopathy and glaucoma will receive topical placebo 8artificial tear substitute) 1x daily for 3 months.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Dubrava

OTHER

Sponsor Role: lead

Responsible Party

Anđela Jukic

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josip Pavan, MD, PhD

Role: STUDY_DIRECTOR

University Hospital Dubrava

Locations

University Hospital Dubrava

Zagreb, Croatia, Croatia

Countries

Croatia

Other Identifiers

2025/0327-4

Identifier Type: -

Identifier Source: org_study_id