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

NCT06960629 | Enrolling By Invitation DMC FDA Drug

• 1 other identifier: 2025/0327-4
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pseudophakic Bullous Keratopathy; Glaucoma

Keywords

Glaucoma; Topical ROCK inhibitors; Netarsudil/latanoprost; corneal edema; pseudophakic bullous keratopathy (PBK)

Outcome Measures

Primary Outcomes (1)

• Visual acuity (VA)

  Visual acuity measurements using Snellen chart and converted to logMAR

  3 months

Secondary Outcomes (1)

• Central corneal thickness (CCT)

  3 months

Study Arms (2)

Rock inhibitor group

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

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

Placebo group

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

Drug: Placebo

Interventions

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

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

Rock inhibitor group

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients of both sex, age between 40 and 90 years with glaucoma and pseudophakic bullous keratopathy.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, Croatia, 10000, Croatia

Location

MeSH Terms

Conditions

Glaucoma; Corneal Edema

Interventions

netarsudil; Latanoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Corneal Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Josip Pavan, MD, PhD

  University Hospital Dubrava

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 7, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)