Trial | NCT00836485  Report issue

Title

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
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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    122
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.
Study Started
Feb 28
2009
Primary Completion
Mar 31
2009
Study Completion
Mar 31
2009
Last Update
Aug 04
2023

Drug Ketotifen 4.0% Patch

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

Drug Placebo

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

Drug Olopatadine 0.2%

1 gtt/eye on two separate occasions

  • Other names: Pataday(TM)

Drug Artificial tears

1 gtt/eye on two separate occasions

1 Experimental

Ketotifen 4.0% Patch

2 Placebo Comparator

Placebo Patch

3 Active Comparator

Pataday(TM)

4 Placebo Comparator

Placebo eye drops

Criteria 

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
No Results Posted