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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date October 2020
Source Bausch & Lomb Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

Drug:
Ketotifen/naphazoline
One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.
Ketotifen
One drop of Ketotifen in study eye at visit 3 and visit 4.
Naphazoline
One drop of naphazoline in study eye at vist 3 and visit 4.
Vehicle
One drop of vehicle in study eye at visit 3 and visit 4.

Locations

Country Name City State
United States Ophthalmic Research Consultants, Inc. North Andover Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

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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