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

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocular Therapeutix, Inc.
• Collaborator: ORA, Inc.
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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