NCT07465913

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4

Timeline
12mo left

Started May 2026

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
May 2026May 2027

First Submitted

Initial submission to the registry

March 6, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 14, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 6, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 6, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

12 months

First QC Date

March 6, 2026

Last Update Submit

May 20, 2026

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Change in mean diurnal intraocular pressure (IOP) from baseline

    3 months post-treatment initiation

Secondary Outcomes (2)

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

    3 months post-treatment initiation

  • Mean percentage decrease in intraocular pressure (IOP) from baseline

    3 months post-treatment initiation

Study Arms (2)

Rocklatan

EXPERIMENTAL

netarsudil and latanoprost 0.02%/0.005%

Drug: Rocklatan 0.02%-0.005% Ophthalmic Solution

Lantanoprost

ACTIVE COMPARATOR

0.005%

Drug: Latanoprost 0.005% Ophthalmic Solution

Interventions

Rocklatan 0.02%-0.005% Ophthalmic SolutionDRUG

netarsudil and latanoprost 0.02%/0.005%

Rocklatan
Latanoprost 0.005% Ophthalmic SolutionDRUG

Latanoprost 0.005%

Lantanoprost

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Centers of Southeast Texas

Beaumont, Texas, 77707, United States

RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

LatanoprostOphthalmic Solutions

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological FactorsPharmaceutical SolutionsSolutionsPharmaceutical PreparationsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Kevin Talbot, MD

    Eye Centers of Southeast Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Contralateral eye study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2026

First Posted

March 12, 2026

Study Start

May 14, 2026

Primary Completion (Estimated)

May 6, 2027

Study Completion (Estimated)

May 6, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)