Back to resultsA Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vehicle
Brimonidine Tartrate 0.01%
Brimonidine Tartrate 0.025%
Oxymetazoline HCl 0.025%
Sponsored by
About this trial
This is an interventional prevention trial for Allergic Conjunctivitis
Eligibility Criteria
Inclusion Criteria:
- Be at least 18 years of age;
- If female, cannot be not pregnant or nursing
- Have a positive skin test reaction to cat hair, cat dander, grasses, ragweed, dog dander, cockroach, dust mite, and/or trees within the past 24 months;
- Have a calculated best corrected visual acuity of 0.6 logMAR or better in each eye as measured using an ETDRS chart;
Exclusion Criteria:
- Have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
- Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety;
- Have a presence of active ocular infection;
- Use specified disallowed medications during the study or appropriate pre-study washout period;
- Have any significant illness;
- Have planned surgery (ocular or systemic) during the trial period or within 30 days after;
- Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
- Be a female who is currently pregnant or nursing.
Sites / Locations
- Ora, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Active Comparator
Active Comparator
Active Comparator
Arm Label
Vehicle
Brimonidine Tartrate 0.01%
Oxymetazoline HCl 0.025%
Brimonidine Tartrate 0.025%
Arm Description
Outcomes
Primary Outcome Measures
Conjunctival Redness
Secondary Outcome Measures
Full Information
NCT ID
NCT01275105
First Posted
January 10, 2011
Last Updated
March 2, 2012
Sponsor
Eye Therapies, LLC
Collaborators
ORA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01275105
Brief Title
A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)
Official Title
A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye Therapies, LLC
Collaborators
ORA, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.
It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.
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 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle
Arm Type
Other
Arm Title
Brimonidine Tartrate 0.01%
Arm Type
Active Comparator
Arm Title
Oxymetazoline HCl 0.025%
Arm Type
Active Comparator
Arm Title
Brimonidine Tartrate 0.025%
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
one drop in each eye at designated visits
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate 0.01%
Intervention Description
one drop in each eye at designated visits
Intervention Type
Drug
Intervention Name(s)
Brimonidine Tartrate 0.025%
Intervention Description
one drop in each eye at designated visits
Intervention Type
Drug
Intervention Name(s)
Oxymetazoline HCl 0.025%
Intervention Description
one drop in each eye at designated visits
Primary Outcome Measure Information:
Title
Conjunctival Redness
Time Frame
at specified timepoints for up to 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Be at least 18 years of age;
If female, cannot be not pregnant or nursing
Have a positive skin test reaction to cat hair, cat dander, grasses, ragweed, dog dander, cockroach, dust mite, and/or trees within the past 24 months;
Have a calculated best corrected visual acuity of 0.6 logMAR or better in each eye as measured using an ETDRS chart;
Exclusion Criteria:
Have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety;
Have a presence of active ocular infection;
Use specified disallowed medications during the study or appropriate pre-study washout period;
Have any significant illness;
Have planned surgery (ocular or systemic) during the trial period or within 30 days after;
Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
Be a female who is currently pregnant or nursing.
Facility Information:
Facility Name
Ora, Inc.
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)
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