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Completed

NCT Number: NCT02445326

OTX-14-007: A Phase 3 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 3

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 refractive surgery (including LASIK procedures)
  • History of retinal detachment, diabetic retinopathy, or active retinal disease
  • Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
  • Use any of the disallowed medications during the period indicated
  • History of IOP increase as a result of steroid treatment

Treatment and study plan

Dexamethasone

Drug

Placebo Vehicle

Other

Primary outcomes

  1. Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6

    Time frame: 3 minutes

    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  2. Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6

    Time frame: 5 minutes

    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  3. Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6

    Time frame: 7 minutes

    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  4. Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6

    Time frame: 7 minutes

    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  5. Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6

    Time frame: 15 minutes

    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

  6. Conjunctival Redness Post-CAC (Conjunctival Allergen Challenge) at Visit 6

    Time frame: 20 minutes

    Modified CAC model (Ora, Andover, MA); Grade 0-4, allowing half unit increments; 0=None

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 3 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
2015
Primary completion
2015
Study completion
2015
First posted
May 15, 2015
Registry last updated
Mar 29, 2018

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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