Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge Model
Information source: ORA, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Conjunctivitis
Intervention: Prednisolone Acetate 1% (Drug); Prednisolone Acetate 0.12% (Drug); Loteprednol Etabonate 0.2% (Drug); Artificial tears (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: ORA, Inc. Official(s) and/or principal investigator(s): Gail L Torkildsen, MD, Principal Investigator, Affiliation: Massachusetts Medical Society, Alpha Omega Honor Society, American board of Ophthalmology
Summary
The purpose of the study is to determine whether prednisolone acetate 1% ophthalmic
suspension is effective in preventing signs and symptoms of allergic conjunctivitis in
comparison with prednisolone acetate 0. 12% ophthalmic suspension, loteprednol etabonate 0. 2%
ophthalmic suspension and placebo in a modified conjunctival allergen challenge (CAC) model.
Clinical Details
Official title: A Single-Center, Randomized, Double-Masked Evaluation of the Efficacy of Prednisolone Acetate 1% Ophthalmic Suspension Compared to Prednisolone Acetate 0.12% Ophthalmic Suspension, Loteprednol Etabonate 0.2% Ophthalmic Suspension, and Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Ocular itching and conjunctival redness
Secondary outcome: ChemosisLid swelling Ciliary redness Episcleral redness
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- At least 18 years of age & either sex, any race
- Willing and able to follow all instructions
- Positive history of ocular allergies
- Reproducible positive ocular allergic reaction induced by conjunctival allergen
challenge
Exclusion Criteria:
- Have planned surgery during trial period
- Female currently pregnant, planning a pregnancy or lactating
- Use of disallowed medications
- Have ocular infections, or ocular conditions that could affect study parameters
- Have moderate to severe dry eye
- Have used an investigational drug or device within 30 days of start of study
- Female that is currently pregnant, planning a pregnancy or lactating
Locations and Contacts
Ophthalmic Research Associates, North Andover, Massachusetts 01845, United States
Additional Information
Starting date: May 2008
Last updated: May 13, 2009
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