Pseudophakic Bullous KeratopathyPhase 2/3NCT06960629
The Effect of ROCK Inhibitors on Corneas of Patients With Glaucoma and Pseudophakic Bullous Keratopathy (PBK)
A Phase 2/3 study testing Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution in people with Pseudophakic Bullous Keratopathy and Glaucoma, run by University Hospital Dubrava at 1 site in Croatia.
Trial 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?… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Pseudophakic Bullous Keratopathy, Glaucoma
- What is being tested?
- Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCroatia
- Study dates
- 12 May 2025to 1 May 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- both sex,
- age between 40 and 90 years
- pseudophakic bullous keratopathy
- glaucoma
Who cannot join
- other anterior segment pathology (corneal opacities);
- ocular surface inflammation
- retinal diseases affecting visual acuity
- current treatment with topical prostaglandin analogue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Topical Rho-kinase (ROCK) Inhibitors on Corneas of Patients With Glaucoma and Pseudophakic Bullous Keratopathy
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.
Read the 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 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.
- Conditions
- Pseudophakic Bullous Keratopathy, Glaucoma
- Being tested
- Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution, Placebo
- Keywords
- Glaucoma, Topical ROCK inhibitors, Netarsudil/latanoprost, corneal edema, pseudophakic bullous keratopathy (PBK)
- Medical subject headings
- Glaucoma, Corneal Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solutionDrug
Patients with pseudophakic bullous keratopthy and glaucoma will receive topical netarsudil/latanoprost 1x daily for 12 weeks.
PlaceboDrug
Patients with pseudophakic bullous keratopathy and glaucoma will receive topical placebo 8artificial tear substitute) 1x daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Rock inhibitor group | Experimental | Group 1 or ROCK inhibitor group will receive topical netarsudil/latanoprost 1x daily for 12 weeks. Receives: Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution |
| Placebo group | Placebo comparator | Placebo group will receive topical placebo (artificial tear substitute) 1x daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (VA)
Visual acuity measurements using Snellen chart and converted to logMAR
Measured: 12 weeks
Secondary outcomes (1)
Central corneal thickness (CCT)
CCT will be measured using OCT (Optovue iVue)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start12 May 2025
- Primary completion1 Apr 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pseudophakic Bullous KeratopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anđela Jukic, University Hospital Dubrava
- Investigators
- Josip Pavan, MD, PhD, Study director, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960629
- Sponsor's protocol ID
- 2025/0327-4
- Status last verified
- Sep 2026
- First submitted
- 28 Apr 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study does not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Rho-kinase (ROCK) Inhibitors on Corneas of Patients With Glaucoma and Pseudophakic Bullous Keratopathy
- ClinicalTrials.gov ID
- NCT06960629
- Acronym / sponsor ID
- 2025/0327-4
- Conditions
- Pseudophakic Bullous Keratopathy, Glaucoma
- Keywords
- Glaucoma, Topical ROCK inhibitors, Netarsudil/latanoprost, corneal edema, pseudophakic bullous keratopathy (PBK)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rock inhibitor group | Experimental | Drug: Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solutionGroup 1 or ROCK inhibitor group will receive topical netarsudil/latanoprost 1x daily for 12 weeks. |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo group will receive topical placebo (artificial tear substitute) 1x daily for 12 weeks. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- both sex,
- age between 40 and 90 years
- pseudophakic bullous keratopathy
- glaucoma
Key exclusion criteria (4 listed)
- other anterior segment pathology (corneal opacities);
- ocular surface inflammation
- retinal diseases affecting visual acuity
- current treatment with topical prostaglandin analogue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solutionPatients with pseudophakic bullous keratopthy and glaucoma will receive topical netarsudil/latanoprost 1x daily for 12 weeks. | Drug | Rock inhibitor group |
| PlaceboPatients with pseudophakic bullous keratopathy and glaucoma will receive topical placebo 8artificial tear substitute) 1x daily for 12 weeks. | Drug | Placebo group |
Primary outcome
Visual acuity (VA)
Time frame: 12 weeks
Visual acuity measurements using Snellen chart and converted to logMAR
1 secondary outcome
Central corneal thickness (CCT)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. This study does not plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josip Pavan, MD, PhD study director
University Hospital Dubrava
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Netarsudil 0.02%/latanoprost 0.005% fixed dose combination ophthalmic solution in people with Pseudophakic Bullous Keratopathy and Glaucoma, run by University Hospital Dubrava at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (VA) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.