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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


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:


Lid swelling

Ciliary redness

Episcleral redness


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 23, 2015

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