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

Sponsor:	ORA, Inc.
Information provided by:	ORA, Inc.
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

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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

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

U.S. FDA Resources

Further study details as provided by ORA, Inc.:

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
Study Completion Date:	June 2008
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

ORA, Inc.

Investigators

Principal Investigator:

Gail L Torkildsen, MD

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

More Information

No publications provided

Responsible Party:	Ophthalmic Research Associates ( Paul Gomes )
Study ID Numbers:	08-003-05
Study First Received:	May 30, 2008
Last Updated:	May 13, 2009
ClinicalTrials.gov Identifier:	NCT00689078 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by ORA, Inc.:

Allergic conjunctivitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Methylprednisolone
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Prednisolone acetate
Neuroprotective Agents
Loteprednol etabonate
Hormones
Hypersensitivity
Therapeutic Uses
Methylprednisolone Hemisuccinate
Immune System Diseases
Conjunctivitis, Allergic

Antineoplastic Agents, Hormonal
Eye Diseases
Gastrointestinal Agents
Methylprednisolone acetate
Anti-Allergic Agents
Conjunctivitis
Protective Agents
Glucocorticoids
Conjunctival Diseases
Pharmacologic Actions
Autonomic Agents
Prednisolone
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009