Trial Outcomes & Findings for Comparison of Two Multifocal Contact Lenses (NCT NCT01250054)

Results Overview

Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

17 participants

Primary outcome timeframe

One week of wear

Results posted on

2012-06-29

Participant Flow

This reporting group includes all enrolled and dispensed participants.

Participant milestones

Participant milestones
Measure	Lotrafilcon B / Comfilcon A Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.	Comfilcon A /Lotrafilcon B Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
Period 1, One Week of Wear STARTED	8	8
Period 1, One Week of Wear COMPLETED	8	8
Period 1, One Week of Wear NOT COMPLETED	0	0
Period 2, One Week of Wear STARTED	7	8
Period 2, One Week of Wear COMPLETED	6	8
Period 2, One Week of Wear NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lotrafilcon B / Comfilcon A Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.	Comfilcon A /Lotrafilcon B Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
Period 2, One Week of Wear Unacceptable subjective vision	1	0

Baseline Characteristics

Comparison of Two Multifocal Contact Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=17 Participants This reporting group includes all enrolled and dispensed subjects.
Age Continuous	48.6 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: One week of wear

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.

Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.

Outcome measures

Outcome measures
Measure	Lotrafilcon B n=16 Participants Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.	Comfilcon A n=13 Participants Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
Overall Vision	8.5 units on a scale Standard Deviation 1.2	8.3 units on a scale Standard Deviation 1.1

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

Joe Rappon, OD, MS, FAAO / Head, Clinical Trial Management

CIBA VISION

Phone: 1-678-415-3343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place