Phase 2
N=43
OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT02468700 ↗Enrolled (actual)
43
Serious AEs
2.3%
Results posted
Mar 2018
Primary outcome: Primary: Total Corneal Fluorescein Staining — 4.09; 5.05 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Dexamethasone (Drug); Placebo Vehicle (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ocular Therapeutix, Inc.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Corneal Fluorescein Staining |
4.64; 6.38 | — |
| PRIMARY Total Corneal Fluorescein Staining |
4.64; 6.38 | — |
| PRIMARY Total Conjunctival Lissamine Green Staining |
6.41; 7.81 | — |
| PRIMARY Total Conjunctival Lissamine Green Staining |
6.41; 7.81 | — |
Summary
The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of dry eye disease
Eligibility Criteria
Inclusion Criteria
- Had a known history of dry eye disease
- Had a minimal Corneal Fluorescein Staining Score and OSDI score in each eye
Exclusion Criteria
- History of intraocular inflammation in either eye
- Use of the anti-inflammatory or immunomodulating agents ocular or systemic for the duration of the study
- Uncontrolled glaucoma or is on medications to treat glaucoma
- History of IOP spikes in either eye
- Active epiphora
Data sourced from ClinicalTrials.gov (NCT02468700). 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.