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

Phase 2

Completed

• Conditions: Ocular Inflammation and Pain
• Interventions: Drug: OTX-DP (Dexamethasone punctum plug); Drug: Placebo Vehicle Punctum Plug

• Registration Number: NCT01666210
• Lead Sponsor: Ocular Therapeutix, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-14
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-16
• Study Start: 2012-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Results First Submitted: 2016-02-09
• Results First Submitted QC: 2017-03-15
• Results First Posted: 2017-04-27
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone Punctum Plug	OTX-DP (Dexamethasone punctum plug)	Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
Placebo Vehicle Punctum Plug	Placebo Vehicle Punctum Plug	Placebo punctum plug insertion

Primary Outcome Measures

Name	Time	Method
Absence of Pain in the Study Eye	Day 8
Absence of Cells in Anterior Chamber of Study Eye	Day 8

Trial Locations

Locations (1)

Chicago Cornea Consultants, Ltd.; 🇺🇸 Hoffman Estates, Illinois, United States