Rocklatan vs Latanoprost Post-DSLT
Part of paid clinical trials in Beaumont, Texas.
- Sponsor
- Eye Centers of Southeast Texas
- Study ID
- NCT07465913
- Phase
- PHASE4
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rocklatan 0.02%-0.005% Ophthalmic Solution — DRUGnetarsudil and latanoprost 0.02%/0.005%
- Latanoprost 0.005% Ophthalmic Solution — DRUGLatanoprost 0.005%
Study Details
This is a randomized, double-masked, single-site, prospective, contralateral eye study designed to evaluate the outcomes of Direct Selective Laser Trabeculoplasty (DSLT) followed by the addition of combination netarsudil and latanoprost (Rocklatan) versus latanoprost monotherapy. The study will be conducted at one investigational site. The primary endpoint is the change in mean diurnal intraocular pressure (IOP) from baseline (post DSLT and post washout) at visit 3 between the two groups. Secondary endpoints include the change in mean IOP from baseline at each timepoint (8am, 12pm, 4pm) at visit 3 between groups, and the mean percentage decrease in IOP from baseline for each group. Assessments will be conducted at three key visits: Visit 1 (Screening Phase and DSLT Procedure on Day 0), Visit 2 (Baseline Visit post washout at Week 8), and Visit 3 (Follow-Up Visit 1 at Week 12). Each visit will include specific examinations and measurements such as visual field and OCT imaging, diurnal IOP measurements, and documentation of adverse events.
Key Dates
- Start date
- May 14, 2026
- Status verified
- May 2026
- Primary completion
- May 6, 2027
- Completion
- May 6, 2027
Study Design
- Enrollment
- 36 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Rocklatannetarsudil and latanoprost 0.02%/0.005%
- Active Comparator: Lantanoprost0.005%
Primary Outcome Measure
Change in mean diurnal intraocular pressure (IOP) from baseline [ Time Frame: 3 months post-treatment initiation ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Eye Centers of Southeast Texas | Beaumont | Texas | 77707 | Kevin Talbot, MD (PRINCIPAL_INVESTIGATOR) |
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