OTX-15:003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Post-Surgical Ocular Inflammation Clinical Trial

Official title:

A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3C 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: NCT02736175
• Other study ID #: OTX-15-003
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2016
• Last updated: October 11, 2017
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2017
• Source: Ocular Therapeutix, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation

Recruitment information / eligibility

• Status: Completed
• Enrollment: 438
• Est. completion date: July 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of posterior chamber lens

• Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

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 in the study eye at Screening

• Any intraocular inflammation in the study eye present during the screening slit lamp examination

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Inflammation
• Post-Surgical Ocular Inflammation
• Post-Surgical Ocular Pain

Intervention

Drug:
• Dexamethasone

Other:
• Placebo Vehicle

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ocular Therapeutix, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of Anterior Chamber Inflammation	Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14	Day 14
Primary	Absence of Ocular Pain	Absence of pain (i.e., score of '0') in the study eye at Day 8	Day 8