This trial is active, not recruiting.

Condition dry eye
Treatments sustained release dexamethasone, 0.4mg, placebo punctum plug, no drug
Phase phase 2
Sponsor Ocular Therapeutix, Inc.
Start date December 2014
End date December 2015
Trial size 43 participants
Trial identifier NCT02468700, OTX-14-006


To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone, 0.4mg) depot when placed in the canaliculus of the eyelid in subjects who exhibit signs and symptoms of dry eye disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
(Active Comparator)
Sustained release dexamethasone, 0.4mg
sustained release dexamethasone, 0.4mg
(Placebo Comparator)
Placebo punctum plug, no drug
placebo punctum plug, no drug

Primary Outcomes

Corneal Fluorescein Staining and Conjunctival Lissamine Green Staining using the NEI Scale
time frame: 30 days
SPEED Dry Eye Questionnaire
time frame: 30 days
Tear Film Break Up Time (TBUT)
time frame: 30 days
Presence of the punctum plug at all study visit time points through Day 30
time frame: 30 days
Pain on the VAS scale
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Has a known history (within the past 6 months) of dry eye disease - Has a corrected LogMAR VA ≤ 0.3 (20/40 Snellen or better) in each eye as assessed at the Screening Visit - Punctum Plug Only Phase: Minimal Cumulative (five areas) Corneal Fluorescein Staining Score of 8 as assessed at the Screening Visit in each eye - Treatment Phase: Minimal Cumulative (five areas) Corneal Fluorescein Staining Score of 5 as assessed on Day 1 (plug insertion) of the Treatment Phase in each eye - Has an OSDI score of ≥18 as assessed at the Screening Visit Exclusion Criteria: - Any history of intraocular inflammation or its presence during the screening or insertion slit lamp examination in either eye - Active or a history of chronic/recurrent ocular or systemic disease that is uncontrolled and will likely affect the study outcomes (e.g. iritis, uveitis, viral/bacterial keratitis, viral/bacterial/allergic conjunctivitis, Rheumatoid Arthritis, Crohn's disease, hepatitis C) - Use of the following anti-inflammatory or immunomodulating agents (e.g. cyclosporine) ocular or systemic for the duration of the study. Subjects will be allowed a maximum washout period of 30 days from informed consent to PV plug insertion. Washout periods for medications prior to plug only insertion are as follows: Systemic corticosteroids - 4 weeks (Note: Systemic corticosteroids in inhaler or nasal spray form are not exclusionary if they are used on a stable dosing regimen for at least 30 days prior to Visit 1 and no change in the medication during the study period is anticipated); Periocular injection of any corticosteroid solution - 3 months; Corticosteroid intra-vitreal depot injection in either eye - 3 months; Ozurdex in either eye - 9 months; Retisert in either eye - 40 months; Topical ocular corticosteroid - 2 weeks; Topical ocular NSAID - 7 days; Topical ocular or systemic cyclosporine - 1 month - Has uncontrolled Glaucoma or is on medications to treat glaucoma - Has ocular hypertension (Normalized IOP of ≥ 22 mmHg), is on medications to treat ocular hypertension or has a history of IOP spikes in either eye - Active or history of chronic or recurrent inflammatory eye disease (e.g. iritis, uveitis) - Active Epiphora - Requires use of any topical ophthalmic solutions other than non-preserved OTC Tears BID (maximum frequency) in the management of dry eye

Additional Information

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
Principal investigator John Sheppard, MD
Description This is a prospective, multi-center, randomized, parallel-arm, bilateral, double-masked, vehicle controlled study to evaluate the safety and efficacy of OTX-DP compared to the Placebo Vehicle (PV) for the treatment of subjects exhibiting signs and symptoms of dry eye disease. This is a serial phase trial. Initially, the effect of the PV will be established during a 6-week Punctum Plug Only Phase. This will establish baseline data to be used for analysis of the Treatment Phase where subjects will be randomized to the study drug (OTX-DP) or the placebo control (PV). Up to forty (40) subjects and eighty (80) eyes, who meet all inclusion and none of the exclusion criteria will be asked to participate in this study.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Ocular Therapeutix, Inc..