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Completed

NCT Number: NCT02062905

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

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

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Key information

Conditions

Chronic Allergic Conjunctivitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Placebo Vehicle

Other

Primary outcomes

  1. Ocular Itching

    Time frame: 14 days post insertion

    Proprietary Ora Calibra Conjunctival Allergen Challenge Ocular Itching Scale (0 - 4 with 0.5 unit increments allowed; "0" = no itching)

Secondary outcomes

  1. Conjunctival Redness

    Time frame: 14 days post insertion

    Proprietary Ora Calibra Ocular Hyperemia Scale (0 - 4 with 0.5 unit increments allowed; "0" = no redness)

Sponsors and collaborators

Lead sponsor

Ocular Therapeutix, Inc.

Industry

Collaborators

  • ORA, Inc.

Registry information

Official study title

A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 2 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC™)

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 14, 2014
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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