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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Illinois
Chicago Cornea Consultants, Ltd.
Hoffman Estates, Illinois, United States, 60169

Sponsors and Collaborators

Ocular Therapeutix, Inc.

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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