Trial Outcomes & Findings for One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses (NCT NCT01300741)

NCT ID: NCT01300741

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.

Participant milestones

Measure	Lotrafilcon B / Galyfilcon A Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon 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	75
Overall Study COMPLETED	72
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Lotrafilcon B / Galyfilcon A Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon 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 Lens deposits	1
Overall Study Lost to Follow-up	1
Overall Study Discomfort	1

Baseline Characteristics

One Month Performance Comparison Between Two Commercially Available Silicone Hydrogel Lenses

Baseline characteristics by cohort

Measure	Lotrafilcon B / Galyfilcon A n=75 Participants Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon 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	30.9 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	22 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=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Comfort on Insertion	8.7 Units on a Scale Standard Deviation 1.4	8.5 Units on a Scale Standard Deviation 1.6

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 during the day was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Comfort During the Day	8.4 Units on a Scale Standard Deviation 1.5	8.4 Units on a Scale Standard Deviation 1.6

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 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=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Comfort at End of Day	7.8 Units on a Scale Standard Deviation 1.9	7.7 Units on a Scale Standard Deviation 2.0

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. Overall comfort was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Overall Comfort	8.3 Units on a Scale Standard Deviation 1.7	8.2 Units on a Scale Standard Deviation 1.7

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. Daytime vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Daytime Vision	8.8 Units on a Scale Standard Deviation 1.6	8.7 Units on a Scale Standard Deviation 1.6

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. Low light vision was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=69 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.	Galyfilcon A n=68 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Low Light Vision	8.6 Units on a Scale Standard Deviation 1.5	8.5 Units on a Scale Standard Deviation 1.5

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. Handling on insertion was graded on a 10-point scale, with 1 being difficult and 10 being easy.

Outcome measures

Measure	Lotrafilcon B n=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Handling on Insertion	8.8 Units on a Scale Standard Deviation 1.4	8.6 Units on a Scale Standard Deviation 1.7

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. Handling at removal was graded on a 10-point scale, with 1 being difficult and 10 being easy.

Outcome measures

Measure	Lotrafilcon B n=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Handling at Removal	8.8 Units on a Scale Standard Deviation 1.5	8.8 Units on a Scale Standard Deviation 1.5

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. 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=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Delivers a Healthy, Natural Feeling	8.6 Units on a Scale Standard Deviation 1.5	8.3 Units on a Scale Standard Deviation 1.9

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. 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=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Lens Awareness	8.1 Units on a Scale Standard Deviation 2.1	7.8 Units on a Scale Standard Deviation 2.5

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. Overall satisfaction was graded on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Overall Satisfaction	8.4 Units on a Scale Standard Deviation 1.7	8.0 Units on a Scale Standard Deviation 2.0

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. 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=69 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.	Galyfilcon A n=69 Participants Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
Purchase Intent	55.1 Percent likely to purchase	56.5 Percent likely to purchase

Adverse Events

Lotrafilcon B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Galyfilcon 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