Back to resultsEvaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Prednisolone Sodium Phosphate Ophthalmic Solution 1%
Tears Naturale II Ophthalmic Solution
Sponsored by
About this trial
This is an interventional prevention trial for Allergic Conjunctivitis
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
Sites / Locations
- Andover Eye Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Prednisolone
Placebo
Arm Description
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Tears Naturale II Ophthalmic Solution, 1%
Outcomes
Primary Outcome Measures
Ocular Itching Change From Baseline to Day 11
Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).
Secondary Outcome Measures
Conjunctival Redness Change From Baseline to Day 11
Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)
Episcleral Redness Change From Baseline to Day 6
Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).
Ciliary Redness Change From Baseline to Day 6
Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01534195
Brief Title
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
Official Title
A Phase 4, Randomized, Double-Masked, Single Center, Placebo-Controlled Adaptive Clinical Trial, Using Prednisolone Sodium Phosphate Ophthalmic Solution, 1%, in Subjects With Allergic Conjunctivitis to Evaluate a Modified Conjunctival Allergen Challenge (CAC) Model
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ORA, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prednisolone
Arm Type
Experimental
Arm Description
Prednisolone Sodium Phosphate Ophthalmic Solution, 1%
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Tears Naturale II Ophthalmic Solution, 1%
Intervention Type
Drug
Intervention Name(s)
Prednisolone Sodium Phosphate Ophthalmic Solution 1%
Intervention Description
One drop in each eye, four times/day for 8 days.
Intervention Type
Drug
Intervention Name(s)
Tears Naturale II Ophthalmic Solution
Intervention Description
one drop in each eye, four times/ day (QID) for 8 days
Primary Outcome Measure Information:
Title
Ocular Itching Change From Baseline to Day 11
Description
Ocular itching, as assessed by the participant, was measured on a 4-point scale 5 minutes after the conjunctival allergen challenge (CAC). 0 was best (no itching), and 4 was worst (worst itching).
Time Frame
5 minutes post-CAC
Secondary Outcome Measure Information:
Title
Conjunctival Redness Change From Baseline to Day 11
Description
Conjunctival Redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (no redness), and 4 was worst (most redness)
Time Frame
7 Minutes post-CAC
Title
Episcleral Redness Change From Baseline to Day 6
Description
Episcleral redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC.0 was best (least redness), and 4 was worst (most redness).
Time Frame
7 minutes post-CAC
Title
Ciliary Redness Change From Baseline to Day 6
Description
Ciliary redness, as measured by the investigator, on a 4-point scale 7 minutes after the CAC. 0 was best (least redness), and 4 was worst (most redness).
Time Frame
7 minutes post-CAC
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Shazly, MD
Organizational Affiliation
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
Official's Role
Principal Investigator
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model
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