Allergic Conjunctivitis Clinical Trial
Official title:
A Multi-Center, Double-Masked, Randomized, Vehicle and Active Controlled Evaluation of the Onset and Duration of Action of KetoNaph Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis
NCT number | NCT00769886 |
Other study ID # | 571 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 2008 |
Est. completion date | June 2009 |
Verified date | October 2020 |
Source | Bausch & Lomb Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 144 |
Est. completion date | June 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years and older |
Eligibility | 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 in 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. |
Country | Name | City | State |
---|---|---|---|
United States | Ophthalmic Research Consultants, Inc. | North Andover | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Bausch & Lomb Incorporated |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ocular Itching | 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. | 3, 5, and 7 minutes post challenge at 14 days | |
Primary | Conjunctival Hyperemia | 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. | 7, 15, and 20 minutes post challenge at 14 days | |
Secondary | Ciliary Redness | Ciliary hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using a 0-4 scale, allowing 0.5- unit increments, with 0.0 = None and 4.0 = Extremely severe. | 7, 15, and 20 minutes post challenge at 14 days | |
Secondary | Episcleral Redness | Episcleral hyperemia (redness) was evaluated by the Investigator at 7, 15, and 20 minutes post challenge. Assessments were made using a 0-4 scale, allowing 0.5- unit increments, with 0.0 = None and 4.0 = Extremely severe. | 7, 15, and 20 minutes post challenge at 14 days | |
Secondary | Chemosis | 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. | 7, 15, and 20 minutes post challenge at 14 days | |
Secondary | Eyelid Swelling | Lid swelling was evaluated by the subject 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. | 7, 15, and 20 minutes post challenge at 14 days | |
Secondary | Percentage of Eyes With Tearing | Tearing was evaluated by the subject at 7, 15, and 20 minutes post challenge (absent or present). Tearing was recorded as either absent or present. | 7, 15, and 20 minutes post challenge at 14 days | |
Secondary | Percentage of Eyes With Ocular Mucus Drainage | 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. | 7, 15, and 20 minutes post challenge at 14 days |
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