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Completed

NCT Number: NCT01666210

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

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.

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Key information

Conditions

Ocular Inflammation and Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chicago Cornea Consultants, Ltd.

Hoffman Estates, Illinois, 60169, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTX-DP (Dexamethasone punctum plug)

Drug

Sustained and tapered release of dexamethasone from hydrogel punctum plug

Placebo Vehicle Punctum Plug

Drug

Hydrogel punctum plug without dexamethasone

Primary outcomes

  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 outcomes

  1. Adverse Events

    Time frame: Duration of each individual subject's participation in the study, up to 60 days

    Measure of adverse events over the duration of each subject's participation in the study.

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 16, 2012
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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