Phase 2 Completed N=43 Randomized Double-blind Treatment

OTX-14-006: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

Dry Eye Disease

Source: ClinicalTrials.gov NCT02468700 ↗

Enrolled (actual)

Serious AEs

2.3%

Results posted

Mar 2018

Primary outcomePrimary: Total Corneal Fluorescein Staining — 4.09; 5.05 units on a scale

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Corneal Fluorescein Staining	4.64; 6.38	—
PRIMARY Total Conjunctival Lissamine Green Staining	6.41; 7.81	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.