Phase 1
N=19
CLN-0045: Safety, and Efficacy of OTX-TIC in Participants With Open Angle Glaucoma or Ocular Hypertension
Ocular Hypertension · Open Angle Glaucoma
Bottom Line
View on ClinicalTrials.gov: NCT04360174 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Ocular Treatment Emergent Adverse Events — 9; 7; 9; 1 Number of Treatment-Emergent Events
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- OTX-TIC (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ocular Therapeutix, Inc.
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Treatment Emergent Adverse Events |
9; 7; 9; 1 | — |
| PRIMARY Efficacy Outcome |
-5.6; -7.0; -3.0; -7.4 | — |
Summary
To assess the safety, tolerability and efficacy of a single sustained release dose of OTX-TIC, a sustained release travoprost drug product, in subjects with primary open-angle glaucoma or ocular hypertension.
Eligibility Criteria
Inclusion Criteria
- Have a documented diagnosis of ocular hypertension or primary open-angle glaucoma
- Have IOP that is currently controlled as assessed by the Investigator
- Have open, normal appearing anterior chamber angles as determined by gonioscopy
Exclusion Criteria
- Have closed angle glaucoma, narrow angle glaucoma, pseudoexfoliation syndrome, pseudoexfoliation glaucoma, pigment dispersion or pigmentary glaucoma, glaucoma diagnosis prior to 15 years of age, inflammatory, neovascular or other secondary
- Have a known or suspected allergy and/or hypersensitivity to a prostaglandin (i.e. travoprost), fluorescein or to any component of the study products
Data sourced from ClinicalTrials.gov (NCT04360174). 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.