Ketotifen/Naphazoline Ophthalmic Solution in the Conjunctival Allergen Challenge Model of Acute Allergic Conjunctivitis.

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00770133
• Collaborator: (none)
• Enrollment: 141
• Location: 1
• Arms: 4
• Duration (Months): 3.9
• Patients Per Site Per Month: 35.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: Ketotifen/naphazoline; Drug: Naphazoline; Drug: Ketotifen; Drug: Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 141 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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.
• Study Start Date: Feb 1, 2010
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmic Research Consultants, Inc.	North Andover	Massachusetts	United States	01845

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Laura Trusso, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00770133
• Other Study ID Numbers: 572
• First Posted: Oct 9, 2008
• Last Update Posted: Oct 27, 2020
• Last Verified: Oct 1, 2020

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic; Ketotifen; Naphazoline

Study Results

Participant Flow

Recruitment Details	There were 70 eyes in the KetoNaph group, 72 in the ketotifen group, 70 in the naphazoline group, and 70 in the vehicle group, for a total of 282 eyes (141 subjects).

Arm/Group Title	Ketotifen/Naphazoline	Ketotifen	Naphazoline	Vehicle
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Period Title: Overall Study
STARTED	35	36	35	35
COMPLETED	32	35	32	32
NOT COMPLETED	3	1	3	3

Baseline Characteristics

Arm/Group Title	Ketotifen/Naphazoline	Ketotifen	Naphazoline	Vehicle	Total
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.	Total of all reporting groups
Overall Participants	35	36	35	35	141
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	36.1	40.7	38.2	38.4	38.4
Sex: Female, Male (Count of Participants)
Female	16 45.7%	21 58.3%	18 51.4%	18 51.4%	73 51.8%
Male	19 54.3%	15 41.7%	17 48.6%	17 48.6%	68 48.2%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challeng assessment.

Arm/Group Title	Ketotifen/Naphazoline	Ketotifen	Naphazoline	Vehicle
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Measure Participants	34	36	34	35
Measure eyes	68	72	68	70
3 minutes post-challenge	0.43 (0.62)	0.40 (0.65)	1.60 (0.92)	1.81 (0.88)
5 minutes post-challenge	0.65 (0.76)	0.59 (0.79)	1.67 (1.01)	1.96 (0.94)
7 minutes post-challenge	0.60 (0.83)	0.56 (0.87)	1.54 (0.96)	1.84 (1.01)

2. Primary Outcome

Title	Conjunctival Redness
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

Outcome Measure Data

Analysis Population Description

The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challeng assessment.

Arm/Group Title	Ketotifen/Naphazoline	Ketotifen	Naphazoline	Vehicle
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Measure Participants	34	36	34	35
Measure eyes	68	72	68	70
7 minutes post-challeng	0.89 (0.87)	1.49 (0.83)	1.63 (0.84)	2.06 (0.77)
15 minutes post-challenge	1.13 (1.00)	1.80 (0.87)	1.69 (0.89)	2.26 (0.78)
20 minutes post-challenge	1.13 (1.02)	1.88 (0.89)	1.57 (0.92)	2.18 (0.85)

3. Secondary Outcome

Title	Ciliary Redness
Description	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.
Time Frame	7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description

This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.

Arm/Group Title	Ketotifen/Naphazoline	Ketotifen	Naphazoline	Vehicle
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Measure Participants	34	36	34	0
Measure eyes	68	72	68	0
7 minutes post-challenge	0.81 (0.86)	1.33 (0.88)	1.49 (0.89)
15 minutes post-challenge	1.05 (1.05)	1.76 (0.91)	1.59 (0.91)
20 minutes post-challenge	1.04 (1.03)	1.76 (0.94)	1.54 (0.92)

4. Secondary Outcome

Title	Episcleral Redness
Description	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.
Time Frame	7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description

This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.

Arm/Group Title	Ketotifen/Naphazoline	Ketotifen	Naphazoline	Vehicle
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Measure Participants	34	36	34	0
Measure eyes	68	72	68	0
7 minutes post-challenge	0.91 (0.89)	1.51 (0.85)	1.65 (0.86)
15 minutes post-challenge	1.17 (1.01)	1.76 (0.88)	1.68 (0.94)
20 minutes post-challenge	1.15 (1.03)	1.88 (0.90)	1.60 (0.94)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.

Arm/Group Title	Ketotifen/Naphazoline	Ketotifen	Naphazoline	Vehicle
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Measure Participants	34	36	34	0
Measure eyes	68	72	68	0
7 minutes post-challenge	0.27 (0.33)	0.28 (0.30)	0.39 (0.40)
15 minutes post-challenge	0.34 (0.38)	0.46 (0.47)	0.54 (0.55)
20 minutes post-challenge	0.39 (0.41)	0.49 (0.46)	0.54 (0.58)

6. Secondary Outcome

Title	Eyelid Swelling
Description	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.
Time Frame	7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description

This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.

Arm/Group Title	Ketotifen/Naphazoline	Ketotifen	Naphazoline	Vehicle
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Measure Participants	34	36	34	0
Measure eyes	68	72	68	0
7 minutes post-challenge	0.2 (0.4)	0.2 (0.4)	0.2 (0.4)
15 minutes post-challenge	0.2 (0.5)	0.2 (0.4)	0.2 (0.4)
20 minutes post-challenge	0.2 (0.5)	0.2 (0.4)	0.2 (0.4)

7. Secondary Outcome

Title	Percentage of Eyes With hTearing
Description	Tearing was evaluated by the participant at 7, 15, and 20 minutes post challenge. Tearing was recorded as either absent or present.
Time Frame	7, 15, and 20 minutes post challenge at 14 days

Outcome Measure Data

Analysis Population Description

This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.

Arm/Group Title	Ketotifen/Naphazoline	Ketotifen	Naphazoline	Vehicle
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Measure Participants	34	36	34	0
Measure eyes	68	72	68	0
7 minutes post-challenge	7	11	13
15 minutes post-challenge	4	9	12
20 minutes post-challenge	5	6	11

8. Secondary Outcome

Title	Percentage of Eyes With Ocular Mucus Discharge
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

Outcome Measure Data

Analysis Population Description

This outcome measure was not assessed for the Vehicle group. The intent to treat population consisted of participants who were randomized, received investigational treatment, and had at least 1 post-challenge assessment.

Arm/Group Title	Ketotifen/Naphazoline	Ketotifen	Naphazoline	Vehicle
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.	Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.	Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.	Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
Measure Participants	34	36	34	0
Measure eyes	68	72	68	0
7 minutes post-challenge	0	0	0
15 minutes post-challenge	0	0	0
20 minutes post-challenge	0	0	0

Adverse Events

Time Frame	14 days
Arm/Group Title	Ketotifen/Naphazoline		Ketotifen		Naphazoline		Vehicle
Arm/Group Description	Ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen/naphazoline: One drop of ketotifen fumarate 0.025% and naphazoline HCl 0.05% ophthalmic solution at visit 3 and visit 4.		Ketotifen ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Ketotifen: One drop of ketotifen fumarate 0.025% ophthalmic solution at visits 3 and 4.		Naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Naphazoline: One drop of naphazoline HCl 0.05% ophthalmic solution at visits 3 and 4.		Vehicle of ketotifen/naphazoline ophthalmic solution administered in either the right eye, left eye or both eyes at visit 3 and visit 4. Vehicle: One drop of vehicle ophthalmic solution at visit 3 and visit 4.
All Cause Mortality
	Ketotifen/Naphazoline		Ketotifen		Naphazoline		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Ketotifen/Naphazoline		Ketotifen		Naphazoline		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/36 (0%)		0/35 (0%)		0/35 (0%)
Other (Not Including Serious) Adverse Events
	Ketotifen/Naphazoline		Ketotifen		Naphazoline		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/36 (0%)		0/35 (0%)		0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Contact sponsor directly for details.