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OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

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ClinicalTrials.gov Identifier: NCT02736175
Recruitment Status : Completed
First Posted : April 13, 2016
Results First Posted : October 11, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Post-Surgical Ocular Pain Post-Surgical Ocular Inflammation Drug: Dexamethasone Other: Placebo Vehicle Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3C Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Actual Study Start Date : October 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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. Absence of Ocular Pain [ Time Frame: Day 8 ]
    Absence of pain (i.e., score of '0') in the study eye at Day 8


Eligibility Criteria
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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:

  • Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of 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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT02736175    
Other Study ID Numbers: OTX-15-003
First Posted: April 13, 2016    Key Record Dates
Results First Posted: October 11, 2017
Last Update Posted: November 13, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cataract
Capsule Opacification
Inflammation
Pathologic Processes
Lens Diseases
Eye 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