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 — DRUG
    netarsudil and latanoprost 0.02%/0.005%
  • Latanoprost 0.005% Ophthalmic Solution — DRUG
    Latanoprost 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: Rocklatan
    netarsudil and latanoprost 0.02%/0.005%
  • Active Comparator: Lantanoprost
    0.005%

Primary Outcome Measure

Change in mean diurnal intraocular pressure (IOP) from baseline [ Time Frame: 3 months post-treatment initiation ]

Locations (1)

FacilityCityStateZIPSite coordinators
Eye Centers of Southeast TexasBeaumontTexas77707
Carol McKee
409-833-0444
Kevin Talbot, MD (PRINCIPAL_INVESTIGATOR)

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