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

NCT ID: NCT01534195

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-02-29

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:

• 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 8 days between Visits 4 and 5.

• Prednisolone phosphate
• Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 19 days

Controls:

Artificial Tears (Tears Naturale® II)

Conditions

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 8 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 8 days

Interventions

Prednisolone Sodium Phosphate Ophthalmic Solution 1%

One drop in each eye, four times/day for 8 days.

Intervention Type: DRUG

Tears Naturale II Ophthalmic Solution

one drop in each eye, four times/ day (QID) for 8 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

Tarek Shazly, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic society of Egypt, Egyptian Glaucoma Society, American Acadamy of Ophthalmology, American Glaucoma Society, The association for research in vision and ophthalmology, international society of refractive surgery, Pan Arab Glaucoma Society

Locations

Andover Eye Associates

Andover, Massachusetts, United States

Countries

United States

Other Identifiers

12-270-0001

Identifier Type: -

Identifier Source: org_study_id