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

Ocular Inflammation and Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01666210
• Other study ID #: OTX-12-002
• Status: Completed
• Phase: Phase 2
• Start date: October 2012
• Est. completion date: August 2013

Study information

• Verified date: September 2021
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Inflammation
• Ocular Inflammation and Pain

Intervention

Drug:
• OTX-DP (Dexamethasone punctum plug)
Sustained and tapered release of dexamethasone from hydrogel punctum plug
• Placebo Vehicle Punctum Plug
Hydrogel punctum plug without dexamethasone

Locations

Country	Name	City	State
United States	Chicago Cornea Consultants, Ltd.	Hoffman Estates	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events	Measure of adverse events over the duration of each subject's participation in the study.	Duration of each individual subject's participation in the study, up to 60 days
Primary	Absence of Cells in Anterior Chamber of Study Eye		Day 8
Primary	Absence of Pain in the Study Eye		Day 8