RecruitingPhase 4NCT06865144

Effect of Rhopressa on Intraocular Pressure (IOP) in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension Post-SLT

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)

Sponsor

East Coast Institute for Research

Enrollment

70 participants

Start Date

Jun 27, 2025

Study Type

INTERVENTIONAL

Conditions

Primary Open Angle Glaucoma or Ocular Hypertension

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

Min Age: 18 Years

Inclusion Criteria7

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

Exclusion Criteria13

History of more than one treatment with SLT in either eye
Unable or unwilling to discontinue current IOP-lowering medication(s), if applicable
Prior or current treatment with a rho kinase inhibitor
Prior microinvasive glaucoma surgery (MIGS)
Advanced stage of glaucoma, as determined by the investigator based on medical record review
Any condition that prevents reliable applanation tonometry in either eye (e.g., significant corneal surface abnormalities, scars, keratoconus)
Previous or currently active corneal disease that, in the opinion of the investigator, could affect the study outcomes
Active or recurrent intraocular infection, inflammation, iritis or uveitis
Retinal disease (e.g., diabetic retinopathy, macular degeneration, central retinal vein or artery occlusion, macular edema)
Intraocular injection performed ≤ 6 months prior to Screening (V1)
Anticipated use of any topical ocular steroids and/or topical ocular nonsteroidal anti-inflammatory drugs (NSAID) during the study period
Current participation in any drug or device clinical investigation, receipt of investigational drug within 6 drug half-lives of Screening (V1), or any previous placement of an investigational device.
Any condition in the opinion of the investigator that would potentially confound the results of this study