Trial Outcomes & Findings for Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks (NCT NCT01293240)

NCT ID: NCT01293240

Last Updated: 2012-07-10

Results Overview

Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 117 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2012-07-10

Participant Flow

Participant milestones

Measure	Lotrafilcon B Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Overall Study STARTED	117
Overall Study COMPLETED	115
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Lotrafilcon B Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Overall Study Noncompliance	2

Baseline Characteristics

Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

Baseline characteristics by cohort

Measure	Lotrafilcon B n=117 Participants Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Age Continuous	45.8 years STANDARD_DEVIATION 12.6 • n=5 Participants
Gender Female	79 participants n=5 Participants
Gender Male	36 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=112 Participants Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Overall Comfort	8.6 Units on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: 4 weeks

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

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

Outcome measures

Measure	Lotrafilcon B n=112 Participants Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Overall Comfort	8.1 Units on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: 2 weeks

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

End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

Outcome measures

Measure	Lotrafilcon B n=112 Participants Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
End of Day Dryness	7.4 Units on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: 4 weeks

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

End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.

Outcome measures

Measure	Lotrafilcon B n=112 Participants Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
End of Day Dryness	7.0 Units on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 2 weeks

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

Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.

Outcome measures

Measure	Lotrafilcon B n=112 Participants Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Ocular Redness	9.1 Units on a scale Standard Deviation 1.4

PRIMARY outcome

Timeframe: 4 weeks

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

Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.

Outcome measures

Measure	Lotrafilcon B n=112 Participants Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Ocular Redness	9.0 Units on a scale Standard Deviation 1.6

PRIMARY outcome

Timeframe: 2 weeks

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

Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=112 Participants Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Visual Clarity	8.4 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 protocol deviations as determined by masked review; discontinuations; and/or missing responses.

Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.

Outcome measures

Measure	Lotrafilcon B n=112 Participants Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Visual Clarity	8.2 Units on a scale Standard Deviation 1.5

PRIMARY outcome

Timeframe: 2 weeks

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

Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.

Outcome measures

Measure	Lotrafilcon B n=112 Participants Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Lens Deposits	0.6 Units on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: 4 weeks

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

Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.

Outcome measures

Measure	Lotrafilcon B n=224 eyes Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Lens Deposits	0.8 Units on a scale Standard Deviation 0.7

PRIMARY outcome

Timeframe: 2 weeks

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

Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.

Outcome measures

Measure	Lotrafilcon B n=222 Eyes Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Corrected Visual Acuity	0.04 logMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: 4 weeks

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

Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.

Outcome measures

Measure	Lotrafilcon B n=223 Eyes Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
Corrected Visual Acuity	0.04 logMAR Standard Deviation 0.08

Adverse Events

Lotrafilcon B

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

Peter Bergenske

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