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)

This study has been completed.
Sponsor:
Collaborator:
ORA, Inc.
Information provided by (Responsible Party):
Eye Therapies, LLC
ClinicalTrials.gov Identifier:
NCT01275105
First received: January 10, 2011
Last updated: March 2, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Vehicle
Drug: Brimonidine Tartrate 0.01%
Drug: Brimonidine Tartrate 0.025%
Drug: Oxymetazoline HCl 0.025%
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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)

Resource links provided by NLM:


Further study details as provided by Eye Therapies, LLC:

Primary Outcome Measures:
  • Conjunctival Redness [ Time Frame: at specified timepoints for up to 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 68
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vehicle Drug: Vehicle
one drop in each eye at designated visits
Active Comparator: Brimonidine Tartrate 0.01% Drug: Brimonidine Tartrate 0.01%
one drop in each eye at designated visits
Active Comparator: Oxymetazoline HCl 0.025% Drug: Oxymetazoline HCl 0.025%
one drop in each eye at designated visits
Active Comparator: Brimonidine Tartrate 0.025% Drug: Brimonidine Tartrate 0.025%
one drop in each eye at designated visits

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01275105

Locations
United States, Massachusetts
Ora, Inc.
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Eye Therapies, LLC
ORA, Inc.
  More Information

No publications provided

Responsible Party: Eye Therapies, LLC
ClinicalTrials.gov Identifier: NCT01275105     History of Changes
Other Study ID Numbers: 10-100-0008
Study First Received: January 10, 2011
Last Updated: March 2, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Oxymetazoline
Phenylephrine
Brimonidine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Cardiotonic Agents
Mydriatics
Protective Agents
Adrenergic alpha-2 Receptor Agonists

ClinicalTrials.gov processed this record on April 15, 2014