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

This study has been completed.
Information provided by:
ORA, Inc. Identifier:
First received: May 30, 2008
Last updated: May 13, 2009
Last verified: May 2009
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by ORA, Inc.:

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

Secondary Outcome Measures:
  • Chemosis [ Time Frame: minutes post-challenge ]
  • Lid swelling [ Time Frame: minutes post challenge ]
  • Ciliary redness [ Time Frame: minutes post challenge ]
  • Episcleral redness [ Time Frame: minutes post challenge ]

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
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


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Paul Gomes, Ophthalmic Research Associates Identifier: NCT00689078     History of Changes
Other Study ID Numbers: 08-003-05
Study First Received: May 30, 2008
Last Updated: May 13, 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
Loteprednol Etabonate
Lubricant Eye Drops
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Allergic Agents processed this record on April 28, 2017