Trial Outcomes & Findings for Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers (NCT NCT01159015)

NCT ID: NCT01159015

Last Updated: 2020-10-05

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 534 participants
• Primary outcome timeframe: 42 days
• Results posted on: 2020-10-05

Participant Flow

Participant milestones

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

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy Volunteers

Baseline characteristics by cohort

Measure	KetoNaph n=357 Participants KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks	Vehicle n=177 Participants Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks	Total n=534 Participants Total of all reporting groups
Age, Continuous	31.8 years STANDARD_DEVIATION 17.2 • n=5 Participants	31.0 years STANDARD_DEVIATION 16.6 • n=7 Participants	31.5 years STANDARD_DEVIATION 17.0 • n=5 Participants
Sex: Female, Male Female	207 Participants n=5 Participants	97 Participants n=7 Participants	304 Participants n=5 Participants
Sex: Female, Male Male	150 Participants n=5 Participants	80 Participants n=7 Participants	230 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	KetoNaph n=357 Participants KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks	Vehicle n=177 Participants Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks
Percentage of Participants With at Least One Adverse Event.	113 Participants	34 Participants

Adverse Events

KetoNaph

Serious events: 3 serious events

Other events: 20 other events

Deaths: 0 deaths

Vehicle

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	KetoNaph n=357 participants at risk KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks	Vehicle n=177 participants at risk Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks
Gastrointestinal disorders Small intestinal obstruction	0.28% 1/357 • 42 days	0.00% 0/177 • 42 days
Hepatobiliary disorders Cholecystitis	0.28% 1/357 • 42 days	0.00% 0/177 • 42 days
Infections and infestations Septic shock	0.28% 1/357 • 42 days	0.00% 0/177 • 42 days
Injury, poisoning and procedural complications Road traffic accident	0.28% 1/357 • 42 days	0.00% 0/177 • 42 days
Psychiatric disorders Drug abuse	0.00% 0/357 • 42 days	0.56% 1/177 • 42 days
Psychiatric disorders Alcohol abuse	0.00% 0/357 • 42 days	0.56% 1/177 • 42 days

Other adverse events

Measure	KetoNaph n=357 participants at risk KetoNaph Ophthalmic Solution ketotifen fumarate 0.025%, naphazoline HCl 0.05% KetoNaph: Ophthalmic Solution administered BID for 6 weeks	Vehicle n=177 participants at risk Vehicle of KetoNaph Ophthalmic Solution Vehicle: Vehicle of KetoNaph ophthalmic solution administered bid for six weeks
Eye disorders Eye Irritation	5.6% 20/357 • 42 days	0.56% 1/177 • 42 days

Additional Information

Study Director

Bausch Health

Phone: 908-300-9920

Email: susan.harris@bauschhealth.com

Results disclosure agreements

• Principal investigator is a sponsor employee Please contact sponsor directly for details.
• Publication restrictions are in place

Restriction type: OTHER