Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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 ultrasound pacymetry (Micro Medical devices, Inc, CA). Information about intraocular pressure and adverse effects will be recorded during the study. Patients will visit every two weeks for checkups and measurements for 3 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rock inhibitor group | Experimental | Group 1 or ROCK inhibitor group will receive topical netarsudil/latanoprost 1x daily for 3 months. |
|
| Placebo group | Placebo Comparator | Placebo group will receive topical placebo (artificial tear substitute) 1x daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity (VA) | Visual acuity measurements using Snellen chart and converted to logMAR | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Central corneal thickness (CCT) | CCT will be measured using OCT (Optovue iVue) | 3 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Josip Pavan, MD, PhD | University Hospital Dubrava | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Dubrava | Zagreb | Croatia | 10000 | Croatia |
This study does not plan to share individual participant data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Patients with pseudophakic bullous keratopathy and glaucoma will receive topical placebo 8artificial tear substitute) 1x daily for 3 months. |
|
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D015715 | Corneal Edema |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000603944 | netarsudil |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
Not provided
Not provided