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NCT02468700 Clinical Trial

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

Dry Eye Clinical Trial

Official title:
A Prospective, Multicenter, Randomized, Parallel-Arm, Bilateral, Double-Masked, Vehicle Controlled Feasibility Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Dry Eye

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02468700
Other study ID # OTX-14-006
Secondary ID
Status Completed
Phase Phase 2
First received June 4, 2015
Last updated March 2, 2018
Start date January 2015
Est. completion date November 2015

Study information
Verified date March 2018
Source Ocular Therapeutix, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date November 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone

Other:
• Placebo Vehicle

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Ocular Therapeutix, Inc. ORA, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Total Corneal Fluorescein Staining National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining) Day 15
Primary Total Corneal Fluorescein Staining National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining) Day 30
Primary Total Conjunctival Lissamine Green Staining National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining) Day 15
Primary Total Conjunctival Lissamine Green Staining National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining) Day 30
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