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:
Eye Therapies, LLC
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
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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:
MedlinePlus related topics:
Pinkeye
Drug Information available for:
Phenylephrine
Phenylephrine hydrochloride
Oxymetazoline
Oxymetazoline hydrochloride
Brimonidine Tartrate
U.S. FDA Resources
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 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 October 18, 2012
