Skip to main content
OpenTrials
Completed

NCT Number: NCT00836485

Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Conjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ora

Andover, Massachusetts, 01810, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years of age of either sex and any race
  • positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months
  • able and willing to avoid all disallowed medication for the washout period and during the study

Exclusion criteria

  • active ocular infection or skin condition
  • ocular surgery within the past 3 months
  • pregnancy or nursing

Treatment and study plan

Ketotifen 4.0% Patch

Drug

This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.

Placebo

Drug

The control is a placebo patch that contains only the inactive ingredients of ketotifen.

Olopatadine 0.2%

Drug

1 gtt/eye on two separate occasions

Other names: Pataday(TM)

Artificial Tears

Drug

1 gtt/eye on two separate occasions

Primary outcomes

  1. Ocular itching and bulbar conjunctival redness

    Time frame: Visit 3 and Visit 4

Secondary outcomes

  1. Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge

    Time frame: Visit 3 and Visit 4

  2. Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms

    Time frame: Visit 3 and Visit 4

Sponsors and collaborators

Lead sponsor

Senju USA, Inc.

Industry

Registry information

Official study title

A Prospective, Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 4, 2009
Registry last updated
Aug 4, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.