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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468700
Recruitment Status : Completed
First Posted : June 11, 2015
Results First Posted : March 29, 2018
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Dry Eye Drug: Dexamethasone Other: Placebo Vehicle Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OTX-DP
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
Drug: Dexamethasone
Placebo Comparator: PV
PV (placebo drug delivery vehicle)
Other: Placebo Vehicle



Primary Outcome Measures :
  1. Total Corneal Fluorescein Staining [ Time Frame: Day 15 ]
    National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)

  2. Total Corneal Fluorescein Staining [ Time Frame: Day 30 ]
    National Eye Institute (NEI) Scale; Grade 0-3 for each region, 5 regions total (Total maximum score=15; 0=No staining)

  3. Total Conjunctival Lissamine Green Staining [ Time Frame: Day 15 ]
    National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)

  4. Total Conjunctival Lissamine Green Staining [ Time Frame: Day 30 ]
    National Eye Institute (NEI) Scale; Grade 0-3 for each region, 6 regions total (Total maximum score=18; 0=No staining)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT02468700    
Other Study ID Numbers: OTX-14-006
First Posted: June 11, 2015    Key Record Dates
Results First Posted: March 29, 2018
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents