Prospective, Randomized, Double- Masked Study to Evaluate the Effect of Rhopressa Versus Placebo on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-Selective Laser Trabeculoplasty (SLT)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to collect data about how Rhopressa affects IOP in patients who have had an SLT procedure in both eyes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years

• Documented diagnosis of bilateral POAG or ocular hypertension as determined by the investigator based on medical record review.

• At Screening (V1), the subject completed SLT in both the eyes within the last 90 days.

• Mean diurnal IOP of 16 to 28 mmHg at Randomization (V2 )

• At Randomization (V2), in the opinion of the investigator, subject may benefit from additional IOP reduction in the study eye and is a candidate for treatment with Rhopressa

• At Randomization (V2), if treated with IOP-lowering medication(s) in either eye prior to SLT, subject has completed the minimum washout period for the medication(s) (see Table 1)

• If female, subject is either incapable of pregnancy (e.g., history of bilateral oophorectomy, hysterectomy, bilateral tubal ligation) or post-menopausal (amenorrheic for at least 2 years) or will use an effective (e.g., double barrier) method of birth control for the duration of the study

Locations
United States
Florida
East Coast Institute for Research at Florida Eye Specialists
RECRUITING
Jacksonville
Contact Information
Primary
Rebecca Goldfaden, PharmD
rg@eastcoastresearch.net
904-267-1584
Time Frame
Start Date: 2025-06-27
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 70
Treatments
Experimental: Rhopressa
Placebo_comparator: Artificial Tears
Sponsors
Leads: East Coast Institute for Research
Collaborators: Florida Eye Specialists, Alcon, a Novartis Company

This content was sourced from clinicaltrials.gov