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OpenTrials
Completed

NCT Number: NCT02089113

OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation

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Key information

Conditions

Post-Surgical Ocular Pain Post-Surgical Ocular Inflammation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber lens
  • Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

Exclusion criteria

  • Any intraocular inflammation in the study eye present during the screening slit lamp examination
  • Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
  • Any intraocular inflammation in the study eye present during the screening slit lamp examination

Treatment and study plan

Dexamethasone

Drug

Placebo Vehicle

Procedure

Primary outcomes

  1. Number of Participants With an Absence of Anterior Chamber Inflammation

    Time frame: Day 14

    Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14

  2. Number of Participants With an Absence of Ocular Pain

    Time frame: Day 8

    Absence of pain (i.e., score of '0') in the study eye at Day 8

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Official study title

A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3B Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 17, 2014
Registry last updated
Sep 26, 2019

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.

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