Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
This study has been completed.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT00770133
First received: October 8, 2008
Last updated: December 7, 2011
Last verified: December 2011
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Purpose
The purpose of this study is to establish the safety and efficacy of ketotifen/naphazoline ophthalmic solution compared to vehicle and its individual components in alleviating the signs and symptoms of conjunctival allergen challenge (CAC)-induced allergic conjunctivitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Allergic Conjunctivitis |
Drug: Ketotifen/naphazoline Drug: Naphazoline Drug: Ketotifen Drug: Vehicle |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-center, Double-masked, Randomized, Placebo-controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis. |
Resource links provided by NLM:
Further study details as provided by Bausch & Lomb Incorporated:
Primary Outcome Measures:
- Ocular itching [ Time Frame: 3, 5 and 7 minutes post-challenge ] [ Designated as safety issue: No ]
- Conjunctival redness [ Time Frame: 7, 15 and 20 minutes post-challenge ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Ciliary and episcleral redness, chemosis, lid swelling, tearing and ocular mucus discharge. [ Time Frame: 7, 15 and 20 minutes post challenge ] [ Designated as safety issue: No ]
| Enrollment: | 133 |
| Study Start Date: | February 2010 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ketotifen/naphazoline
Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
|
Drug: Ketotifen/naphazoline
One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.
|
|
Placebo Comparator: Vehicle
Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
|
Drug: Vehicle
One drop of vehicle ophthalmic solution at visit 3 and visit 4.
|
|
Active Comparator: Naphazoline
Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
|
Drug: Naphazoline
One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.
|
|
Active Comparator: Ketotifen
Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
|
Drug: Ketotifen
One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.
|
Eligibility| Ages Eligible for Study: | 6 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Positive history of ocular allergies and positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months.
- Calculated best-corrected visual acuity of 0.7 logMAR or better in each eye as measured using the ETDRS chart.
- Positive bilateral conjunctival allergen challenge(CAC) reaction within 10 minutes of instillation of the last titration of allergen at visit 1.
- Positive bilateral CAC reaction for at least 2 out of 3 time points at visit 2.
Exclusion Criteria:
- Known contraindications or sensitivities to the study medication or its components.
- Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
- Use of disallowed medications during the period indicated prior to study enrollment or during the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770133
Locations
| United States, Massachusetts | |
| Ophthalmic Research Consultants, Inc. | |
| North Andover, Massachusetts, United States, 01845 | |
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
| Study Director: | Laura Trusso | Bausch & Lomb Incorporated |
More Information
No publications provided
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT00770133 History of Changes |
| Other Study ID Numbers: | 572 |
| Study First Received: | October 8, 2008 |
| Last Updated: | December 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Conjunctivitis, Allergic Conjunctivitis Conjunctival Diseases Eye Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Ketotifen Naphazoline Antipruritics Dermatologic Agents Therapeutic Uses Pharmacologic Actions Histamine H1 Antagonists |
Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Allergic Agents Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Nasal Decongestants Vasoconstrictor Agents Cardiovascular Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 23, 2013