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Rocklatan for Glaucoma

Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Eye Centers of Southeast Texas
Must be taking: Prostaglandin analogs
Must not be taking: Rocklatan, Latanoprost
Disqualifiers: Ocular hypertension, Glaucoma surgery, Advanced glaucoma, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

KT

Kevin Talbot, MD

Principal Investigator

Eye Centers of Southeast Texas

Are You a Good Fit for This Trial?

Inclusion Criteria

Best-corrected visual acuity (BCVA) ≥20/60 in both eyes
Ability and willingness to provide informed consent
I am an adult with mild to moderate open-angle glaucoma in both eyes.
See 2 more

Exclusion Criteria

Known hypersensitivity to Rocklatan, latanoprost, or study medication components
Pregnancy or lactation
I have advanced glaucoma that threatens my central vision.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Day 0
1 visit (in-person)

DSLT Procedure

Direct Selective Laser Trabeculoplasty (DSLT) procedure is performed

Day 0
1 visit (in-person)

Washout Period

Participants undergo a washout period before baseline measurements

8 weeks

Baseline Visit

Baseline measurements are taken post washout

Week 8
1 visit (in-person)

Treatment

Participants receive either Rocklatan or Latanoprost treatment

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Latanoprost
  • Rocklatan

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: RocklatanExperimental Treatment1 Intervention
Group II: LantanoprostActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eye Centers of Southeast Texas

Lead Sponsor

Sengi

Industry Sponsor

Trials
28
Recruited
2,100+

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