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

Phase 2

Completed

• Conditions: Dry Eye
• Interventions: Other: Placebo Vehicle; Drug: Dexamethasone

• Registration Number: NCT02468700
• Lead Sponsor: Ocular Therapeutix, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-11
• Primary Completion: 2015-08
• Study Completion: 2015-11
• Results First Submitted: 2017-10-30
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-02
• Last Update Submitted: 2018-03-02
• Results First Posted: 2018-03-29
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PV	Placebo Vehicle	PV (placebo drug delivery vehicle)
OTX-DP	Dexamethasone	OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use

Primary Outcome Measures

Name	Time	Method
Total Corneal Fluorescein Staining	Day 30	National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)
Total Conjunctival Lissamine Green Staining	Day 30	National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)