Back to resultsKetotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ketotifen/naphazoline
Ketotifen
Naphazoline
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis
Eligibility 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 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.
Sites / Locations
- Ophthalmic Research Consultants, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
KetoNaph
Naphazoline
Ketotifen
Vehicle
Arm Description
KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution
Naphazoline HCl 0.05% ophthalmic solution
Ketotifen fumarate 0.025% ophthalmic solution
Vehicle of KetoNaph ophthalmic solution
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT00769886
First Posted
October 8, 2008
Last Updated
October 5, 2020
Sponsor
Bausch & Lomb Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00769886
Brief Title
Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KetoNaph
Arm Type
Experimental
Arm Description
KetoNaph (ketotifen fumarate 0.025%, naphazoline HCl 0.05%) ophthalmic solution
Arm Title
Naphazoline
Arm Type
Active Comparator
Arm Description
Naphazoline HCl 0.05% ophthalmic solution
Arm Title
Ketotifen
Arm Type
Active Comparator
Arm Description
Ketotifen fumarate 0.025% ophthalmic solution
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle of KetoNaph ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Ketotifen/naphazoline
Intervention Description
One drop of ketotifen/naphazoline in study eye at visit 3 and visit 4.
Intervention Type
Drug
Intervention Name(s)
Ketotifen
Intervention Description
One drop of Ketotifen in study eye at visit 3 and visit 4.
Intervention Type
Drug
Intervention Name(s)
Naphazoline
Intervention Description
One drop of naphazoline in study eye at vist 3 and visit 4.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
One drop of vehicle in study eye at visit 3 and visit 4.
Primary Outcome Measure Information:
Title
Ocular Itching
Description
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.
Time Frame
3, 5, and 7 minutes post challenge at 14 days
Title
Conjunctival Hyperemia
Description
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.
Time Frame
7, 15, and 20 minutes post challenge at 14 days
Secondary Outcome Measure Information:
Title
Ciliary Redness
Description
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.
Time Frame
7, 15, and 20 minutes post challenge at 14 days
Title
Episcleral Redness
Description
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.
Time Frame
7, 15, and 20 minutes post challenge at 14 days
Title
Chemosis
Description
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.
Time Frame
7, 15, and 20 minutes post challenge at 14 days
Title
Eyelid Swelling
Description
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.
Time Frame
7, 15, and 20 minutes post challenge at 14 days
Title
Percentage of Eyes With Tearing
Description
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.
Time Frame
7, 15, and 20 minutes post challenge at 14 days
Title
Percentage of Eyes With Ocular Mucus Drainage
Description
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.
Time Frame
7, 15, and 20 minutes post challenge at 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Facility Information:
Facility Name
Ophthalmic Research Consultants, Inc.
City
North Andover
State/Province
Massachusetts
ZIP/Postal Code
01845
Country
United States
12. IPD Sharing Statement
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Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Allergic Conjunctivitis.
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