Phase 2
Completed N=41
Safety and Efficacy of ENV515 Travoprost Extended Release (XR) in Patients With Bilateral Ocular Hypertension or Primary Open Angle Glaucoma
Glaucoma and Ocular Hypertension
Source: ClinicalTrials.gov NCT02371746 ↗
Enrolled (actual)
41
Serious AEs
12.2%
Results posted
Oct 2019
Primary outcomePrimary: Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1) — -5.10; -6.65; -3.17; -5.67 mm Hg — p=<0.001
Summary
This is a multiple cohort study that will evaluate the safety and efficacy of ENV515 travoprost XR in patients with open-angle glaucoma or ocular hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Change From Baseline Average Intraocular Pressure Diurnal Measurement by Treatment Group Population (Cohort 1) |
-5.10; -6.65; -3.17; -5.67 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of either ocular hypertension or open angle glaucoma in both eyes.
- Are currently treated with topical PGA for ocular hypertension in both eyes.
- Patients who in the opinion of the Investigator: have an IOP in both eyes that is considered to be adequately controlled, can be safely withdrawn from IOP medications in both eyes during the washout period, and who are not considered to be at significant risk for disease progression throughout the trial.
Exclusion Criteria
- Eye surgery (including cataract surgery) within the past 3 months.
- History of glaucoma related surgery.
Data sourced from ClinicalTrials.gov (NCT02371746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.