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

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ClinicalTrials.gov Identifier: NCT01666210
Recruitment Status : Completed
First Posted : August 16, 2012
Results First Posted : April 27, 2017
Last Update Posted : April 27, 2017
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 ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Condition or disease Intervention/treatment Phase
Ocular Inflammation and Pain Drug: OTX-DP (Dexamethasone punctum plug) Drug: Placebo Vehicle Punctum Plug Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 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 II 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 2012
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Dexamethasone Punctum Plug
Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
Drug: OTX-DP (Dexamethasone punctum plug)
Sustained and tapered release of dexamethasone from hydrogel punctum plug
Placebo Comparator: Placebo Vehicle Punctum Plug
Placebo punctum plug insertion
Drug: Placebo Vehicle Punctum Plug
Hydrogel punctum plug without dexamethasone



Primary Outcome Measures :
  1. Absence of Cells in Anterior Chamber of Study Eye [ Time Frame: Day 8 ]
  2. Absence of Pain in the Study Eye [ Time Frame: Day 8 ]

Other Outcome Measures:
  1. Adverse Events [ Time Frame: Duration of each individual subject's participation in the study ]
    Measure of adverse events over the duration of each subject's participation in the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule
  • Is greater than or equal to 21 years of age
  • Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens

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 at Screening
  • Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface

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): NCT01666210


Locations
United States, Illinois
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, United States, 60169
Sponsors and Collaborators
Ocular Therapeutix, Inc.

Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT01666210     History of Changes
Other Study ID Numbers: OTX-12-002
First Posted: August 16, 2012    Key Record Dates
Results First Posted: April 27, 2017
Last Update Posted: April 27, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Inflammation
Cataract
Capsule Opacification
Pathologic Processes
Lens Diseases
Eye Diseases
Dexamethasone acetate
Dexamethasone
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