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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00689078
Recruitment Status : Completed
First Posted : June 3, 2008
Last Update Posted : May 14, 2009
Information provided by:
ORA, Inc.

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.

Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis Drug: Prednisolone Acetate 1% Drug: Prednisolone Acetate 0.12% Drug: Loteprednol Etabonate 0.2% Drug: Artificial tears Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : May 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Arm Intervention/treatment
Active Comparator: 1
Prednisolone acetate 1%
Drug: Prednisolone Acetate 1%
One drop OU
Other Name: Pred Forte
Active Comparator: 2
Prednisolone acetate 0.12%
Drug: Prednisolone Acetate 0.12%
One drop OU
Other Name: Pred Mild
Active Comparator: 3
Loteprednol Etabonate 0.2%
Drug: Loteprednol Etabonate 0.2%
One drop OU
Other Name: Alrex
Placebo Comparator: 4
Drug: Artificial tears
One drop OU

Primary Outcome Measures :
  1. Ocular itching and conjunctival redness [ Time Frame: minutes post challenge ]

Secondary Outcome Measures :
  1. Chemosis [ Time Frame: minutes post-challenge ]
  2. Lid swelling [ Time Frame: minutes post challenge ]
  3. Ciliary redness [ Time Frame: minutes post challenge ]
  4. Episcleral redness [ Time Frame: minutes post challenge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00689078

United States, Massachusetts
Ophthalmic Research Associates
North Andover, Massachusetts, United States, 01845
Sponsors and Collaborators
ORA, Inc.
Principal Investigator: Gail L Torkildsen, MD Massachusetts Medical Society, Alpha Omega Honor Society, American board of Ophthalmology

Responsible Party: Paul Gomes, Ophthalmic Research Associates Identifier: NCT00689078     History of Changes
Other Study ID Numbers: 08-003-05
First Posted: June 3, 2008    Key Record Dates
Last Update Posted: May 14, 2009
Last Verified: May 2009

Keywords provided by ORA, Inc.:
Allergic conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Lubricant Eye Drops
Loteprednol Etabonate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Ophthalmic Solutions