Evaluation of Prednisolone in a Modified Conjunctival Allergen Challenge Model

NCT ID: NCT01730872

Last Updated: 2019-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2012-12-31

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

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)

Conditions

Chronic Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Prednisolone

Prednisolone Sodium Phosphate Ophthalmic Solution, 1%

Group Type: EXPERIMENTAL

Prednisolone Sodium Phosphate Ophthalmic Solution 1%

Intervention Type: DRUG

One drop in each eye, four times/day for 4 days.

Placebo

Tears Naturale II Ophthalmic Solution, 1%

Group Type: PLACEBO_COMPARATOR

Tears Naturale II Ophthalmic Solution

Intervention Type: DRUG

one drop in each eye, four times/ day (QID) for 4 days

Interventions

Prednisolone Sodium Phosphate Ophthalmic Solution 1%

One drop in each eye, four times/day for 4 days.

Intervention Type: DRUG

Tears Naturale II Ophthalmic Solution

one drop in each eye, four times/ day (QID) for 4 days

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gail Torkildsen, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts Medical Society, Alpha Omega Alpha Honor Society, American Academy of Ophthalmology

Locations

Andover Eye Associates

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

12-270-0007

Identifier Type: -

Identifier Source: org_study_id