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OTX-14-001: A Phase 2 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis

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Ocular Therapeutix

Status and phase

Completed
Phase 2

Conditions

Chronic Allergic Conjunctivitis

Treatments

Drug: Dexamethasone
Other: Placebo Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT02062905
OTX-14-001

Details and patient eligibility

About

The objective of the study was to evaluate the efficacy and safety of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of chronic allergic conjunctivitis

Enrollment

68 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
  • Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion criteria

  • History of ocular surgical intervention within the past 3 months
  • Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
  • Use any of the following disallowed medications during the period indicated

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

68 participants in 2 patient groups, including a placebo group

OTX-DP
Experimental group
Description:
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
Treatment:
Drug: Dexamethasone
PV
Placebo Comparator group
Description:
PV (placebo drug delivery vehicle)
Treatment:
Other: Placebo Vehicle

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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