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

University Hospital Dubrava

Status and phase: Completed; Phase 3; Phase 2

Conditions: Glaucoma; Pseudophakic Bullous Keratopathy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06960629

2025/0327-4

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 50 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Rock inhibitor group

Experimental group

Description:

Group 1 or ROCK inhibitor group will receive topical netarsudil/latanoprost 1x daily for 12 weeks.

Treatment:

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

Placebo group

Placebo Comparator group

Description:

Placebo group will receive topical placebo (artificial tear substitute) 1x daily for 12 weeks.

Treatment:

Drug: Placebo