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

Sponsor
University Hospital Dubrava
Study ID
NCT06960629
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Glaucoma
  • Pseudophakic Bullous Keratopathy

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
May 7, 2025
Start date
Jan 1, 2025
Status verified
Jul 2026
Primary completion
Apr 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rock inhibitor group
    Group 1 or ROCK inhibitor group will receive topical netarsudil/latanoprost 1x daily for 12 weeks.
  • Placebo Comparator: Placebo group
    Placebo group will receive topical placebo (artificial tear substitute) 1x daily for 12 weeks.

Primary Outcome Measure

Visual acuity (VA) [ Time Frame: 12 weeks ]

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