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

NCT00836485 | Completed Phase 2

• 1 other identifier: SNJ-ALK201/08-003-11
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

• Ocular itching and bulbar conjunctival redness

  Visit 3 and Visit 4

Secondary Outcomes (2)

• 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

Study Arms (4)

1

EXPERIMENTAL

Ketotifen 4.0% Patch

Drug: Ketotifen 4.0% Patch

2

PLACEBO COMPARATOR

Placebo Patch

Drug: Placebo

3

ACTIVE COMPARATOR

Pataday(TM)

Drug: Olopatadine 0.2%

4

PLACEBO COMPARATOR

Placebo eye drops

Drug: Artificial tears

Interventions

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.

1

Placebo DRUG

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

2

Olopatadine 0.2% DRUG

1 gtt/eye on two separate occasions

Also known as: Pataday(TM)

3

Artificial tears DRUG

1 gtt/eye on two separate occasions

4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Senju USA, Inc.: lead

Study Sites (1)

Ora

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Ketotifen; Transdermal Patch; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Equipment and Supplies; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Gail Torkildsen, MD

  ORA, Inc.

  PRINCIPAL INVESTIGATOR

• TBD TBD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 4, 2009
• Study Start: February 1, 2009
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 4, 2023

Record last verified: 2023-08

Locations

US (1)