Phase 3
N=565
Phase 3 Study Evaluating Safety and Efficacy of OTX-TP in Subjects With OAG or OHT
Open Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02914509 ↗Enrolled (actual)
565
Serious AEs
2.3%
Results posted
Oct 2021
Primary outcome: Primary: Mean IOP — 21; 22.9; 20.2; 21.9 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Travoprost (Drug); Placebo Vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ocular Therapeutix, Inc.
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean IOP |
22.8; 23.2; 21.7; 22.5; 21.4; 22.1 | — |
| PRIMARY Mean IOP |
22.8; 23.2; 21.7; 22.5; 21.4; 22.1 | — |
| PRIMARY Mean IOP |
22.8; 23.2; 21.7; 22.5; 21.4; 22.1 | — |
Summary
The objective of the study is to evaluate evaluate the safety and IOP lowering efficacy of OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension
Eligibility Criteria
Inclusion Criteria
- Documented diagnosis of ocular hypertension with an open angle of Schaffer Grade 3 or greater or open-angle glaucoma without pseudoexfoliation or pigment dispersion or evidence of traumatic angle recession
- IOP is currently controlled as assessed by the Investigator
Exclusion Criteria
- Punctum size smaller than 0.4 mm or greater than 0.9 mm in either eye as measured using a standard punctum gauge
- A history of an inadequate response or no response to topical prostaglandin
- Known or suspected allergy and/or hypersensitivity to travoprost or any prostaglandin, fluorescein, or to any component of the study products
Data sourced from ClinicalTrials.gov (NCT02914509). 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.