Phase 2 N=60 Randomized Double-blind Treatment

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

Ocular Inflammation and Pain

Bottom Line

View on ClinicalTrials.gov: NCT01666210 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

Apr 2017

Primary outcome: Primary: Absence of Cells in Anterior Chamber of Study Eye — 6; 3 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: OTX-DP (Dexamethasone punctum plug) (Drug); Placebo Vehicle Punctum Plug (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Ocular Therapeutix, Inc.
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Absence of Cells in Anterior Chamber of Study Eye	6; 3	—
PRIMARY Absence of Pain in the Study Eye	23; 9	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01666210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.