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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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ClinicalTrials.gov Identifier: NCT01275105
Recruitment Status : Completed
First Posted : January 12, 2011
Last Update Posted : March 6, 2012
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Eye Therapies, LLC

Tracking Information
First Submitted Date  ICMJE January 10, 2011
First Posted Date  ICMJE January 12, 2011
Last Update Posted Date March 6, 2012
Study Start Date  ICMJE January 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2011)
Conjunctival Redness [ Time Frame: at specified timepoints for up to 30 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01275105 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Allergic Conjunctivitis
Intervention  ICMJE
  • Drug: Vehicle
    one drop in each eye at designated visits
  • Drug: Brimonidine Tartrate 0.01%
    one drop in each eye at designated visits
  • Drug: Brimonidine Tartrate 0.025%
    one drop in each eye at designated visits
  • Drug: Oxymetazoline HCl 0.025%
    one drop in each eye at designated visits
Study Arms  ICMJE
  • Vehicle
    Intervention: Drug: Vehicle
  • Active Comparator: Brimonidine Tartrate 0.01%
    Intervention: Drug: Brimonidine Tartrate 0.01%
  • Active Comparator: Oxymetazoline HCl 0.025%
    Intervention: Drug: Oxymetazoline HCl 0.025%
  • Active Comparator: Brimonidine Tartrate 0.025%
    Intervention: Drug: Brimonidine Tartrate 0.025%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 1, 2012)
68
Original Estimated Enrollment  ICMJE
 (submitted: January 11, 2011)
80
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01275105
Other Study ID Numbers  ICMJE 10-100-0008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eye Therapies, LLC
Study Sponsor  ICMJE Eye Therapies, LLC
Collaborators  ICMJE ORA, Inc.
Investigators  ICMJE Not Provided
PRS Account Eye Therapies, LLC
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP