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Completed

NCT Number: NCT06960629

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

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 12 weeks and visit the clinic once every two weeks for checkups and tests.

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Key information

Conditions

Pseudophakic Bullous Keratopathy Corneal Diseases Corneal Edema Eye Diseases Glaucoma Ocular Hypertension

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital Dubrava

Zagreb, Croatia, 10000

About this study

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 OCT (Optovue Ivue). Information about intraocular pressure and adverse effects will be recorded during the study. Patients will visit every two weeks for checkups and measurements for 12 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • current treatment with topical prostaglandin analogue

Treatment and study plan

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 12 weeks.

Placebo

Drug

Patients with pseudophakic bullous keratopathy and glaucoma will receive topical placebo 8artificial tear substitute) 1x daily for 12 weeks.

Primary outcomes

  1. Visual acuity (VA)

    Time frame: 12 weeks

    Visual acuity measurements using Snellen chart and converted to logMAR

Secondary outcomes

  1. Central corneal thickness (CCT)

    Time frame: 12 weeks

    CCT will be measured using OCT (Optovue iVue)

Sponsors and collaborators

Lead sponsor

University Hospital Dubrava

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 7, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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