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

This study has been completed.
Sponsor:
Information provided by:
ORA, Inc.
ClinicalTrials.gov Identifier:
NCT00689078
First received: May 30, 2008
Last updated: May 13, 2009
Last verified: May 2009
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

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

Keywords provided by ORA, Inc.:
Allergic conjunctivitis

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Loteprednol etabonate
 Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on May 21, 2013