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

Sponsored by:	Ophthalmic Research Associates
Information provided by:	Ophthalmic Research Associates
ClinicalTrials.gov Identifier:	NCT00689078

Purpose

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.

Condition	Intervention	Phase
Allergic Conjunctivitis	Drug: Prednisolone Acetate 1% Drug: Prednisolone Acetate 0.12% Drug: Loteprednol Etabonate 0.2% Drug: Artificial tears	Phase IV

Drug Information available for: Prednisolone 6-Methylprednisolone Depo-medrol Medrol veriderm Methylprednisolone Methylprednisolone hemisuccinate Methylprednisolone Sodium Succinate Prednisolone acetate Prednisolone sodium phosphate Prednisolone Sodium Succinate Loteprednol Loteprednol etabonate 16-Methyleneprednisolone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Ophthalmic Research Associates:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	36
Study Start Date:	May 2008
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Prednisolone acetate 1%	Drug: Prednisolone Acetate 1% One drop OU
2: Active Comparator Prednisolone acetate 0.12%	Drug: Prednisolone Acetate 0.12% One drop OU
3: Active Comparator Loteprednol Etabonate 0.2%	Drug: Loteprednol Etabonate 0.2% One drop OU
4: Placebo Comparator Placebo	Drug: Artificial tears One drop OU

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689078

Locations

United States, Massachusetts
Ophthalmic Research Associates
North Andover, Massachusetts, United States, 01845

Sponsors and Collaborators

Ophthalmic Research Associates

Investigators

Principal Investigator:

Gail L Torkildsen, MD

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

More Information

Responsible Party:	Ophthalmic Research Associates ( Paul Gomes )
Study ID Numbers:	08-003-05
Study First Received:	May 30, 2008
Last Updated:	May 30, 2008
ClinicalTrials.gov Identifier:	NCT00689078
Health Authority:	United States: Institutional Review Board

Keywords provided by Ophthalmic Research Associates:

Allergic conjunctivitis

Study placed in the following topic categories:

Hypersensitivity
Conjunctivitis, Allergic
Methylprednisolone
Eye Diseases
Prednisolone
Hypersensitivity, Immediate

Methylprednisolone acetate
Prednisolone acetate
Conjunctivitis
Loteprednol etabonate
Conjunctival Diseases
Methylprednisolone Hemisuccinate

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Anti-Allergic Agents

Protective Agents
Neuroprotective Agents
Glucocorticoids
Hormones
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009