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
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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 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Dexamethasone Punctum Plug
Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
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Drug: OTX-DP (Dexamethasone punctum plug)
Sustained and tapered release of dexamethasone from hydrogel punctum plug
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Placebo Comparator: Placebo Vehicle Punctum Plug
Placebo punctum plug insertion
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Drug: Placebo Vehicle Punctum Plug
Hydrogel punctum plug without dexamethasone
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- Absence of Cells in Anterior Chamber of Study Eye [ Time Frame: Day 8 ]
- Absence of Pain in the Study Eye [ Time Frame: Day 8 ]
- 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.

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

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