Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01159015
• Collaborator: (none)
• Enrollment: 534
• Arms: 2
• Duration (Months): 3

Study Details

Study Description

Brief Summary

This study is being conducted to evaluate the safety of KetoNaph ophthalmic solution in healthy adult subjects and in pediatric subjects with a history or family history of ocular allergy.

Condition or Disease	Intervention/Treatment	Phase
Allergic Conjunctivitis	Drug: KetoNaph; Drug: Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 534 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Screening
• Official Title: A Multi-center, Double-masked, Randomized, Placebo-controlled, Parallel-group Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy, Normal Volunteers
• Study Start Date: Jul 1, 2010
• Actual Primary Completion Date: Sep 1, 2010
• Actual Study Completion Date: Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KetoNaph KetoNaph Ophthalmic Solution	Drug: KetoNaph; Ophthalmic Solution administered BID for 6 weeks
Placebo Comparator: Vehicle Vehicle of KetoNaph Ophthalmic Solution	Drug: Vehicle; Vehicle of KetoNaph ophthalmic solution administered bid for six weeks

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With at Least One Adverse Event. [42 days]

   An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects less than 18 years of age, have either a history or family history of ocular allergy.

• ocular health within normal limits, including a calculated best-corrected visual acuity of 0.3 logMar or better, in each eye. For subjects under 10 years old who are developmentally unable to use the ETDRS chart, visual acuity will be made using the LEA symbols. For these subjects, 20-foot Snellen equivalent units of 20/63 or better in both eyes will be required.

Exclusion Criteria:

• Contraindications or sensitivities to the use of any of the investigational product(s) or their components.

• Subjects less than 18 years of age that have had symptoms and/or signs of allergic conjunctivitis/rhinitis and/or treatment with topical or systemic anti-allergy therapy, or have had a history of ragweed hypersensitivity during the 21-day period prior to visit 1.

• Surgical intervention within three months prior to Visit 1 or during the refractive surgery within the past 6 months.

• A known history of retinal detachment, diabetic retinopathy, or active retinal disease;

• An active ocular infection (bacterial, viral or fungal

• Use of any topical ophthalmic agents other than investigational products during study participation or within 5 days of beginning study treatment.

• Current or anticipated use of contact lenses during study participation or within 5 days of beginning study treatment.

• Current, prior (within 14 days of beginning study treatment) or anticipated use of systemic corticosteroids, and/or any other systemic medications which the Investigator feels may confound study data or interfere with the subject's study participation. Prior (within 21 days of beginning study treatment), current or anticipated use of any topical (including nasal) or systemic anti-allergy medications.

• Intraocular pressure (IOP) that is less than 5 mmHg or greater than 22 mmHg or have a normal IOP with a diagnosis of glaucoma.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Principal Investigator: Tuyen Ong, MD, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT01159015
• Other Study ID Numbers: 586
• First Posted: Jul 9, 2010
• Last Update Posted: Oct 5, 2020
• Last Verified: Oct 1, 2020

• Additional relevant MeSH terms: Conjunctivitis; Conjunctivitis, Allergic

Study Results

Participant Flow

Arm/Group Title	KetoNaph	Vehicle
Arm/Group Description	KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks	Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks
Period Title: Overall Study
STARTED	357	177
COMPLETED	339	170
NOT COMPLETED	18	7

Baseline Characteristics

Arm/Group Title	KetoNaph	Vehicle	Total
Arm/Group Description	KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks	Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks	Total of all reporting groups
Overall Participants	357	177	534
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.8 (17.2)	31.0 (16.6)	31.5 (17.0)
Sex: Female, Male (Count of Participants)
Female	207 58%	97 54.8%	304 56.9%
Male	150 42%	80 45.2%	230 43.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With at Least One Adverse Event.
Description	An adverse event was defined as unfavorable and unintended sign, symptom, or disease temporally associated with the use of a test article, whether or not considered related to test article.
Time Frame	42 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	KetoNaph	Vehicle
Arm/Group Description	KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks	Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks
Measure Participants	357	177
Count of Participants [Participants]	113 31.7%	34 19.2%

Adverse Events

Time Frame	42 days
Arm/Group Title	KetoNaph		Vehicle
Arm/Group Description	KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks		Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks
All Cause Mortality
	KetoNaph		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	KetoNaph		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/357 (0.8%)		1/177 (0.6%)
Gastrointestinal disorders
Small intestinal obstruction	1/357 (0.3%)		0/177 (0%)
Hepatobiliary disorders
Cholecystitis	1/357 (0.3%)		0/177 (0%)
Infections and infestations
Septic shock	1/357 (0.3%)		0/177 (0%)
Injury, poisoning and procedural complications
Road traffic accident	1/357 (0.3%)		0/177 (0%)
Psychiatric disorders
Drug abuse	0/357 (0%)		1/177 (0.6%)
Alcohol abuse	0/357 (0%)		1/177 (0.6%)
Other (Not Including Serious) Adverse Events
	KetoNaph		Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/357 (5.6%)		1/177 (0.6%)
Eye disorders
Eye Irritation	20/357 (5.6%)		1/177 (0.6%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Please contact sponsor directly for details.