Trial Outcomes & Findings for Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only (NCT NCT01268501)

Results Overview

Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

3 weeks of wear

Results posted on

2012-06-29

Participant Flow

A total of 103 participants were recruited at 25 US sites from December 8, 2010, to January 31, 2011.

Seven participants were enrolled in the study but not dispensed due to failing inclusion/exclusion criteria (1); withdrawing consent/disinterest (4); discomfort (1); and unacceptable subjective vision (1). These participants are included in the Actual Enrollment calculation, but not Participant Flow or Baseline Characteristics calculations.

Participant milestones

Participant milestones
Measure	Lotrafilcon B Multifocal Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
Overall Study STARTED	96
Overall Study COMPLETED	87
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotrafilcon B Multifocal Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	3
Overall Study Unacceptable Subjective Vision	3
Overall Study Handling Difficulties	2

Baseline Characteristics

Clinical Assessment of a Multifocal Contact Lens for People Who Use Reading Glasses Only

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lotrafilcon B Multifocal n=96 Participants Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
Age Continuous	44.9 years STANDARD_DEVIATION 2.7 • n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Region of Enrollment United States	96 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 weeks of wear

Population: Per Protocol. Two participants were excluded from analysis due to major protocol deviations as determined by masked review.

Overall convenience with contact lenses, as interpreted by the participant and reported on a questionnaire as a single, retrospective evaluation of 3 weeks of wear time. Overall convenience is measured on a 4-point scale: 1=very satisfied; 2=satisfied; 3=dissatisfied; 4=very dissatisfied. Results were reported as a percentage of participants who responded, "very satisfied" or "satisfied."

Outcome measures

Outcome measures
Measure	Lotrafilcon B Multifocal n=85 Participants Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
Overall Convenience With Contact Lenses	82.4 Percentage of participants Interval 72.6 to 89.8

Adverse Events

Lotrafilcon B Multifocal

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 Alcon Clinical

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