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

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 Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis
• Intervention / Treatment: Drug: Ketotifen 4.0% Patch; Drug: Placebo; Drug: Olopatadine 0.2%; Drug: Artificial tears

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Ora

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Ketotifen 4.0% Patch	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.
Placebo Comparator: 2; Placebo Patch	Drug: Placebo; The control is a placebo patch that contains only the inactive ingredients of ketotifen.
Active Comparator: 3; Pataday(TM)	Drug: Olopatadine 0.2%; 1 gtt/eye on two separate occasions; Other Names: Pataday(TM)
Placebo Comparator: 4; Placebo eye drops	Drug: Artificial tears; 1 gtt/eye on two separate occasions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ocular itching and bulbar conjunctival redness	Visit 3 and Visit 4

Secondary Outcome Measures

Outcome Measure	Time Frame
Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge	Visit 3 and Visit 4
Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms	Visit 3 and Visit 4

Collaborators and Investigators

• Sponsor: Senju USA, Inc.
• Investigators: Principal Investigator: TBD TBD; Principal Investigator: Gail Torkildsen, MD, ORA, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 2, 2009
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (Estimated): February 4, 2009

Study Record Updates

• Last Update Posted (Actual): August 4, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Pharmaceutical Solutions; Histamine H1 Antagonists, Non-Sedating; Ophthalmic Solutions; Lubricant Eye Drops; Olopatadine Hydrochloride; Ketotifen
• Other Study ID Numbers: SNJ-ALK201/08-003-11