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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier:
NCT01666210
First received: August 14, 2012
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Ocular Therapeutix, Inc.:

Primary Outcome Measures:
  • Absence of cells in anterior chamber of study eye [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Absence of pain in the study eye [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 37 days ] [ Designated as safety issue: Yes ]

Enrollment: 60
Study Start Date: October 2012
Study Completion Date: August 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01666210

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

No publications provided

Responsible Party: Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier: NCT01666210     History of Changes
Other Study ID Numbers: OTX-12-002
Study First Received: August 14, 2012
Last Updated: November 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Capsule Opacification
Inflammation
Cataract
Eye Diseases
Lens Diseases
Pathologic Processes
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014