Health TrialsbyHealthPanel

Rocklatan vs Latanoprost Post-DSLT

ConditionGlaucoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEye Centers of Southeast Texas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rocklatan 0.02%-0.005% Ophthalmic Solution

    Drug

    netarsudil and latanoprost 0.02%/0.005%

  • Latanoprost 0.005% Ophthalmic Solution

    Drug

    Latanoprost 0.005%

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: RocklatanExperimental treatment 1 intervention
Group B: LantanoprostActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in mean diurnal intraocular pressure (IOP) from baseline

Time frame
3 months post-treatment initiation

Secondary outcomes

1

Change in mean intraocular pressure (IOP) from baseline at each time of day

8am, 12pm, 4pm

Time frame
3 months post-treatment initiation
2

Mean percentage decrease in intraocular pressure (IOP) from baseline

Measured using the Snellen chart at each follow-up visit.

Time frame
3 months post-treatment initiation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eye Centers of Southeast Texas

Lead sponsor

Sengi

Collaborator

Source ClinicalTrials.gov
Apply now