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Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Ocular Therapeutix logo

Ocular Therapeutix

Status and phase

Completed
Phase 3

Conditions

Post Ocular Surgical Inflammation and Pain

Treatments

Drug: Punctum Plug
Drug: Dexamethasone

Study type

Interventional

Funder types

Industry

Identifiers

NCT02034019
OTX-13-002

Details and patient eligibility

About

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 post-surgical inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Enrollment

247 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

247 participants in 2 patient groups, including a placebo group

OTX-DP (Dexamethasone Punctum Plug)
Active Comparator group
Description:
Resorbable hydrogel drug delivery vehicle containing dexamethasone
Treatment:
Drug: Dexamethasone
Drug: Punctum Plug
PVPP (Placebo Punctum Plug)
Placebo Comparator group
Description:
Resorbable hydrogel drug delivery vehicle containing no drug
Treatment:
Drug: Punctum Plug

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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