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Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

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ClinicalTrials.gov Identifier: NCT01730872
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):
ORA, Inc.

Brief Summary:

The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,

Prednisolone, assessed by the following measures:

Chronic Allergic Inflammation assessed using confocal microscopy Ocular itching Conjunctival redness


Condition or disease Intervention/treatment Phase
Chronic Allergic Conjunctivitis Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1% Drug: Tears Naturale II Ophthalmic Solution Phase 4

Detailed Description:

Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 4 days between Visits 3 and 4.

Prednisolone phosphate Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 2 weeks

Controls:

Artificial Tears (Tears Naturale® II)


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Single-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of Prednisolone Sodium Phosphate Ophthalmic Solution, 1% Compared to Placebo in a Modified Conjunctival Allergen Challenge (CAC) Model
Study Start Date : November 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012


Arm Intervention/treatment
Experimental: Prednisolone
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Drug: Prednisolone Sodium Phosphate Ophthalmic Solution 1%
One drop in each eye, four times/day for 4 days.
Placebo Comparator: Placebo
Tears Naturale II Ophthalmic Solution, 1%
Drug: Tears Naturale II Ophthalmic Solution
one drop in each eye, four times/ day (QID) for 4 days



Primary Outcome Measures :
  1. Inflammation [ Time Frame: 90 minutes post CAC ]
    Visit 3A compared to Visit 5A


Secondary Outcome Measures :
  1. Ocular Itching [ Time Frame: 3 minutes post CAC ]
    Visit 3B compared to 5B

  2. Ocular Redness [ Time Frame: 7 minutes post-CAC ]
    Visit 3B compared to 5B



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT01730872


Locations
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
ORA, Inc.
Investigators
Principal Investigator: Gail Torkildsen, MD Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology

Responsible Party: ORA, Inc.
ClinicalTrials.gov Identifier: NCT01730872     History of Changes
Other Study ID Numbers: 12-270-0007
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013

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