Skip to main content
OpenTrials
Completed

NCT Number: NCT02468700

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Placebo Vehicle

Other

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Collaborators

  • ORA, Inc.

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 11, 2015
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.