Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Interventions
- Registration Number
- NCT00770133
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 141
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ketotifen/naphazoline Ketotifen/naphazoline Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle Vehicle Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline Naphazoline Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen Ketotifen Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4.
- Primary Outcome Measures
Name Time Method Ocular Itching 3, 5, and 7 minutes post challenge at 14 days Ocular itching was evaluated by the participant at 3, 5, and 7 minutes post challenge. Assessments were made using a 0-4 numerical analog scale, allowing 0.5-unit increments (but disallowing 0.25-unit increments), where: 0.0=None and 4.0=Incapacitating itch with an irresistible urge to rub
Conjunctival Redness 7, 15, and 20 minutes post challenge at 14 days Conjunctival hyperemia was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were completed using a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.
- Secondary Outcome Measures
Name Time Method Episcleral Redness 7, 15, and 20 minutes post challenge at 14 days Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.
Chemosis 7, 15, and 20 minutes post challenge at 14 days Chemosis was evaluated by the Investigator at 7, 15, and 20 minutes post challenge on a 0-4 numerical analog scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.
Eyelid Swelling 7, 15, and 20 minutes post challenge at 14 days Lid swelling was evaluated by the participant at 7, 15, and 20 minutes post challenge on a 0-3 numerical analog scale, with 0.5-unit increments disallowed, where: 0.0=None and 3.0=Severe.
Percentage of Eyes With Ocular Mucus Discharge 7, 15, and 20 minutes post challenge at 14 days Ocular mucous discharge was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Mucous discharged was recorded as either absent or present.
Ciliary Redness 7, 15, and 20 minutes post challenge at 14 days Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using the same 0-4 scale, allowing 0.5-unit increments, where: 0.0=None and 4.0=Extremely severe.
Percentage of Eyes With hTearing 7, 15, and 20 minutes post challenge at 14 days Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. Tearing was recorded as either absent or present.
Trial Locations
- Locations (1)
Ophthalmic Research Consultants, Inc.
🇺🇸North Andover, Massachusetts, United States