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Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

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: NCT02034019
Recruitment Status : Completed
First Posted : January 13, 2014
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.

Brief Summary:
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Condition or disease Intervention/treatment Phase
Post Ocular Surgical Inflammation and Pain Drug: Dexamethasone Drug: Punctum Plug Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 247 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: OTX-DP (Dexamethasone Punctum Plug)
Resorbable hydrogel drug delivery vehicle containing dexamethasone
Drug: Dexamethasone
Drug: Punctum Plug
Placebo Comparator: PVPP (Placebo Punctum Plug)
Resorbable hydrogel drug delivery vehicle containing no drug
Drug: Punctum Plug



Primary Outcome Measures :
  1. Absence of cells in anterior chamber of the study eye [ Time Frame: Day 14 ]
  2. Absence of pain in study eye [ Time Frame: Day 8 ]

Secondary Outcome Measures :
  1. Cells in the anterior chamber in the study eye [ Time Frame: Days 2, 4, 8, 30 ]
  2. Pain in the study eye [ Time Frame: Days 2, 4, 14, 30 ]


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 a posterior chamber intraocular 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02034019


Locations
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United States, Texas
Texan Eye / Keystone Research, Ltd.
Austin, Texas, United States, 78731
Sponsors and Collaborators
Ocular Therapeutix, Inc.
Investigators
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Study Director: Deepa Mulani Sponsor GmbH

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Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT02034019     History of Changes
Other Study ID Numbers: OTX-13-002
First Posted: January 13, 2014    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Dexamethasone
Dexamethasone acetate
BB 1101
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
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action