Trial Outcomes & Findings for Tetracaine Versus Lidocaine Gel for Anesthetic Effect and Comfort in Patients Undergoing LASIK (NCT NCT01383200)

Results Overview

Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

1 hour (60minutes) post LASIK operation

Results posted on

2017-08-11

Participant Flow

The recruitment period is now over. Eligible patients included healthy patients undergoing bilateral LASIK surgery.

Participant milestones

Participant milestones
Measure	Tetracaine Right Eye / Lidocaine Left Eye Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel 11 eyes received 0.5% tetracaine drops.	Tetracaine Left Eye / Lidocaine Right Eye Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel 11 eyes received 20% lidocaine gel.
Overall Study STARTED	5	6
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Tetracaine Versus Lidocaine Gel for Anesthetic Effect and Comfort in Patients Undergoing LASIK

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TetracaineRight Eye / LidocaineLeft Eye n=5 Participants 0.5% tetracaine drops Right eye /2% lidocaine gel Left eye	TetracaineLeft Eye /LidocaineRight Eye n=6 Participants 0.5% tetracaine drops Left eye / 2% lidocaine gel Right eye	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Region of Enrollment United States	5 participants n=93 Participants	6 participants n=4 Participants	11 participants n=27 Participants

PRIMARY outcome

Timeframe: 1 hour (60minutes) post LASIK operation

Population: Five participants received tetracaine right eye and lidocaine left eye and six participants received lidocaine right eye and tetracaine left eye. A total of 22 eyes were analyzed for pain.

Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort

Outcome measures

Outcome measures
Measure	Tetracaine n=11 eyes 0.5% tetracaine drops	Lidocaine n=11 eyes 2% lidocaine gel
Participants Score on Pain Scale	1.95 Score on scale Standard Deviation .75	2.01 Score on scale Standard Deviation .93

Adverse Events

Tetracaine Right Eye / Lidocaine Left Eye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tetracaine Left Eye / Lidocaine Right Eye

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sonia Yoo

Bascom Palmer Eye Institute

Phone: 305-243-2020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place