Glaucoma
Conditions
Brief summary
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.
Interventions
netarsudil and latanoprost 0.02%/0.005%
Latanoprost 0.005%
Sponsors
Eye Centers of Southeast Texas
Sengi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Contralateral eye study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (≥18 years) with a diagnosis of mild to moderate bilateral primary open-angle glaucoma (POAG) or open-angle glaucoma (OAG). * On 3 topical glaucoma medications at screening, one of which must be a prostaglandin analog. * Post-DSLT and post-washout, baseline intraocular pressure (IOP) 16-36 mmHg in both eyes. * Best-corrected visual acuity (BCVA) ≥20/60 in both eyes. * Ability and willingness to provide informed consent.
Exclusion criteria
* Ocular hypertension only (no glaucomatous damage). * Inability or medical ineligibility for washout of ocular hypotensive medications. * Prior selective laser trabeculoplasty (SLT) within 12 months of screening. * History of glaucoma surgery (trabeculectomy, tube shunt, minimally invasive glaucoma surgery \[MIGS\] affecting outflow). * Narrow or closed angles with gonioscopy (Shaffer grading ≤2). * Active ocular infection, uveitis, or severe dry eye. * Corneal pathology interfering with IOP measurement. * Advanced glaucoma (threat to fixation). * Known hypersensitivity to Rocklatan, latanoprost, or study medication components. * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean diurnal intraocular pressure (IOP) from baseline | 3 months post-treatment initiation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean intraocular pressure (IOP) from baseline at each time of day | 3 months post-treatment initiation | 8am, 12pm, 4pm |
| Mean percentage decrease in intraocular pressure (IOP) from baseline | 3 months post-treatment initiation | Measured using the Snellen chart at each follow-up visit. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKevin Talbot, MD
Eye Centers of Southeast Texas
Outcome results
None listed