Trial Outcomes & Findings for Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials (NCT NCT01371539)

Results Overview

The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

1 week

Results posted on

2012-08-03

Participant Flow

Participants were recruited and enrolled from 12 US private practices.

Five participants were enrolled, but not dispensed, due to failing inclusion/exclusion criteria (4) and unacceptable subjective vision (1). Baseline characteristics are presented on all enrolled and dispensed participants: 104.

Participant milestones

Participant milestones
Measure	Lotrafilcon B / Comfilcon A Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.	Comfilcon A / Lotrafilcon B Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Period One: One Week STARTED	53	51
Period One: One Week COMPLETED	53	50
Period One: One Week NOT COMPLETED	0	1
Period Two: One Week STARTED	53	50
Period Two: One Week COMPLETED	53	47
Period Two: One Week NOT COMPLETED	0	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotrafilcon B / Comfilcon A Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.	Comfilcon A / Lotrafilcon B Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
Period One: One Week Lost to Follow-up	0	1
Period Two: One Week Lost to Follow-up	0	1
Period Two: One Week Unacceptable Objective Visual Acuity	0	1
Period Two: One Week Time/job conflict	0	1

Baseline Characteristics

Clinical Comparison of Two Multifocal Contact Lenses Made of Silicone Hydrogel Materials

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=104 Participants All enrolled and dispensed participants
Age Continuous	49.0 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	76 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants
Region of Enrollment United States	104 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal distance eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.

Outcome measures

Outcome measures
Measure	Lotrafilcon B n=98 Participants Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.	Comfilcon A n=101 Participants Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
Corrected Distance Binocular Visual Measurement in Normal Illumination Reported as Binocular Distance Visual Acuity	-0.00 logMAR Standard Deviation 0.07	0.00 logMAR Standard Deviation 0.06

PRIMARY outcome

Timeframe: 1 week

Population: The Efficacy Evaluable Set (EES) contained all enrolled and dispensed subjects with no major protocol deviations as determined by masked review that also completed a minimum of 4 days of lens wear with either study product and attended an assessing follow-up visit.

The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equated to a logMAR acuity of 0.0 and was considered normal near eyesight. A positive logMAR value indicated poorer vision, and a negative value denoted better visual acuity.

Outcome measures

Outcome measures
Measure	Lotrafilcon B n=98 Participants Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.	Comfilcon A n=102 Participants Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
Corrected Near Binocular Visual Measurement in Normal Illumination Reported as Binocular Near Visual Acuity	0.12 logMAR Standard Deviation 0.10	0.10 logMAR Standard Deviation 0.12

Adverse Events

Lotrafilcon B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comfilcon 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

Stacie Cummings, O.D.

Alcon Research, Ltd.

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