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:

ClinicalTrials.gov Identifier:

NCT01666210

First Posted: August 16, 2012

Last Update Posted: April 27, 2017

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.

Information provided by (Responsible Party):

Ocular Therapeutix, Inc.

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 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

Resource links provided by NLM:

MedlinePlus related topics: Cataract

Drug Information available for: Dexamethasone Dexamethasone sodium phosphate Dexamethasone acetate

U.S. FDA Resources

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 ]
Absence of Pain in the Study Eye [ Time Frame: Day 8 ]

Other Outcome Measures:

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.


Enrollment:	60
Actual Study Start Date:	October 2012
Study Completion Date:	August 2013
Primary Completion Date:	August 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

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

Contacts and Locations

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.

More Information


Responsible Party:	Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier:	NCT01666210 History of Changes
Other Study ID Numbers:	OTX-12-002
First Submitted:	August 14, 2012
First Posted:	August 16, 2012
Results First Submitted:	February 9, 2016
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

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