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Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

Information source: ORA, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Allergic Conjunctivitis

Intervention: Prednisolone Sodium Phosphate Ophthalmic Solution 1% (Drug); Tears Naturale II Ophthalmic Solution (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: ORA, Inc.

Official(s) and/or principal investigator(s):
Gail Torkildsen, MD, Principal Investigator, Affiliation: Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology


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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Inflammation

Secondary outcome:

Ocular Itching

Ocular Redness

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)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Locations and Contacts

Andover Eye Associates, Andover, Massachusetts 01810, United States
Additional Information

Starting date: November 2012
Last updated: May 14, 2013

Page last updated: August 23, 2015

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