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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2023-08-04

No results posted yet for this study

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

Interventions

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

DRUG

Artificial tears

1 gtt/eye on two separate occasions

Sponsors & Collaborators

  • Senju USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Gail Torkildsen, MD · ORA, Inc.

  • TBD TBD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00836485 on ClinicalTrials.gov