Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge Model - Tabular View

Tracking Information

First Received Date ^ICMJE

May 30, 2008

Last Updated Date

May 13, 2009

Start Date ^ICMJE

May 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Ocular itching and conjunctival redness [ Time Frame: minutes post challenge ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00689078 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Chemosis [ Time Frame: minutes post-challenge ] [ Designated as safety issue: No ]
Lid swelling [ Time Frame: minutes post challenge ] [ Designated as safety issue: No ]
Ciliary redness [ Time Frame: minutes post challenge ] [ Designated as safety issue: No ]
Episcleral redness [ Time Frame: minutes post challenge ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge Model

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Allergic Conjunctivitis

Intervention ^ICMJE

Drug: Prednisolone Acetate 1%
Drug: Prednisolone Acetate 0.12%
Drug: Loteprednol Etabonate 0.2%
Drug: Artificial tears

Study Arms / Comparison Groups

Active Comparator: Prednisolone acetate 1%
Active Comparator: Prednisolone acetate 0.12%
Active Comparator: Loteprednol Etabonate 0.2%
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2008

Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00689078

Responsible Party

Paul Gomes, Ophthalmic Research Associates

Study ID Numbers ^ICMJE

08-003-05

Study Sponsor ^ICMJE

ORA, Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Gail L Torkildsen, MD

Massachusetts Medical Society, Alpha Omega Honor Society, American board of Ophthalmology

Information Provided By

ORA, Inc.

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP