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Active Not Recruiting NCT06865144

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

Conditions: Primary Open Angle Glaucoma or Ocular Hypertension

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 70
Sponsor: East Coast Institute for Research

Location: East Coast Institute for Research at Florida Eye Specialists Jacksonville Florida

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 Criteria

Inclusion Criteria: 1. Age ≥ 18 years 2. Documented diagnosis of bilateral POAG or ocular hypertension as determined by the investigator based on medical record review. 3. At Screening (V1), the subject completed SLT in both the eyes within the last 90 days. 4. Mean diurnal IOP of 16 to 28 mmHg at Randomization (V2 ) 5. 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 6. 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) 7. 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 Criteria: 1. History of more than one treatment with SLT in either eye 2. Unable or unwilling to discontinue current IOP-lowering medication(s), if applicable 3. Prior or current treatment with a rho kinase inhibitor 4. Prior microinvasive glaucoma surgery (MIGS) 5. Advanced stage of glaucoma, as determined by the investigator based on medical record review 6. Any condition that prevents reliable applanation tonometry in either eye (e.g., significant corneal surface abnormalities, scars, keratoconus) 7. Previous or currently active corneal disease that, in the opinion of the investigator, could affect the study outcomes 8. Active or recurrent intraocular infection, inflammation, iritis or uveitis 9. Retinal disease (e.g., diabetic retinopathy, macular degeneration, central retinal vein or artery occlusion, macular edema) 10. Intraocular injection performed ≤ 6 months prior to Screening (V1) 11. Anticipated use of any topical ocular steroids and/or topical ocular nonsteroidal anti-inflammatory drugs (NSAID) during the study period 12. 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. 13. Any condition in the opinion of the investigator that would potentially confound the results of this study

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06865144). StuddyBuddy aggregates publicly available trial information.