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

NCT ID: NCT01666210

Last Updated: 2021-10-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ocular Inflammation and Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexamethasone Punctum Plug

Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days

Group Type ACTIVE_COMPARATOR

OTX-DP (Dexamethasone punctum plug)

Intervention Type DRUG

Sustained and tapered release of dexamethasone from hydrogel punctum plug

Placebo Vehicle Punctum Plug

Placebo punctum plug insertion

Group Type PLACEBO_COMPARATOR

Placebo Vehicle Punctum Plug

Intervention Type DRUG

Hydrogel punctum plug without dexamethasone

Interventions

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OTX-DP (Dexamethasone punctum plug)

Sustained and tapered release of dexamethasone from hydrogel punctum plug

Intervention Type DRUG

Placebo Vehicle Punctum Plug

Hydrogel punctum plug without dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Chicago Cornea Consultants, Ltd.

Hoffman Estates, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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OTX-12-002

Identifier Type: -

Identifier Source: org_study_id