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:
Ocular Therapeutix, Inc.
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
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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 (Adult, Senior) |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01666210
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
| 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:
|
Inflammation Cataract Capsule Opacification Pathologic Processes Lens Diseases Eye Diseases Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate 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 |
ClinicalTrials.gov processed this record on September 23, 2016