Trial Outcomes & Findings for Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses (NCT NCT01300767)

NCT ID: NCT01300767

Last Updated: 2012-07-10

Results Overview

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2012-07-10

Participant Flow

Participants were recruited from 5 US study centers.

• One participant was enrolled but not dispensed due to failing inclusion/exclusion criteria. This participant is included in the Actual Enrollment calculation, but not in the Participant Flow or Baseline Characteristics calculations.

Participant milestones

Measure	Lotrafilcon B /Balafilcon A Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
Overall Study STARTED	74
Overall Study COMPLETED	70
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Lotrafilcon B /Balafilcon A Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
Overall Study Discomfort	2
Overall Study Biomicroscopy	1
Overall Study Unacceptable fit	1

Baseline Characteristics

Four Week Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

Baseline characteristics by cohort

Measure	Lotrafilcon B /Balafilcon A n=74 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
Age Continuous	32.8 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: Analysis conducted per protocol, with exclusions due to reasons such as, major protocol deviations as determined by masked review; discontinuations; and/or missing responses.

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort on insertion was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=70 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Comfort on Insertion	8.3 Units on a Scale Standard Deviation 1.6	7.5 Units on a Scale Standard Deviation 2.0

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=70 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Comfort During the Day	7.9 Units on a Scale Standard Deviation 1.8	7.2 Units on a Scale Standard Deviation 2.0

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Comfort at end of day was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=70 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Comfort at End of Day	7.1 Units on a Scale Standard Deviation 2.3	6.4 Units on a Scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=70 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Overall Comfort	7.7 Units on a Scale Standard Deviation 1.9	6.9 Units on a Scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=70 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Daytime Vision	8.7 Units on a Scale Standard Deviation 1.4	8.5 Units on a Scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=70 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Low Light Vision	8.5 Units on a Scale Standard Deviation 1.4	8.3 Units on a Scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=69 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Handling on Insertion	8.5 Units on a Scale Standard Deviation 1.8	7.5 Units on a Scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=69 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Handling at Removal	8.5 Units on a Scale Standard Deviation 1.8	7.9 Units on a Scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Delivers a healthy, natural feeling was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=70 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Delivers a Healthy, Natural Feeling	7.9 Units on a Scale Standard Deviation 2.0	6.8 Units on a Scale Standard Deviation 2.5

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Lens awareness was graded on a 10-point scale, with 1 being very aware and 10 being not aware.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=70 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Lens Awareness	7.7 Units on a Scale Standard Deviation 2.3	6.2 Units on a Scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=70 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Overall Satisfaction	7.8 Units on a Scale Standard Deviation 2.1	6.6 Units on a Scale Standard Deviation 2.3

PRIMARY outcome

Timeframe: 4 weeks

As interpreted and recorded by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. The participant was asked, "How likely would you be to purchase these lenses?" Purchase intent was graded on a 5-point Likert scale: Definitely would purchase, probably would purchase, may or may not purchase, probably would not purchase, definitely would not purchase. The Top-2-box response (definitely would purchase, probably would purchase) was calculated and reported as a percentage of all responses.

Outcome measures

Measure	Lotrafilcon B n=70 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.	Balafilcon A n=70 Participants Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
Purchase Intent	64.3 Percent likely to purchase	35.7 Percent likely to purchase

Adverse Events

Lotrafilcon B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Balafilcon A

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

Director of Clinical Trials

Alcon Research

Phone: 1-800-241-7629

Results disclosure agreements

• Principal investigator is a sponsor employee For a period of 10 years, the clinical investigator must hold all trial-related information and documents confidential and must agree to obtain sponsor's written consent before discussing, presenting, publicizing, or otherwise disclosing any preclinical and/or clinical data or impressions from this trial.
• Publication restrictions are in place

Restriction type: OTHER