Trial Outcomes & Findings for Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands (NCT NCT00965237)

Results Overview

Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

1 week of wear

Results posted on

2012-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Multifocal CL / Single Vision CL+ Reading Glasses Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.	Single Vision CL + Reading Glasses / Multifocal CL Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
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	8	8
Period 2, One Week of Wear COMPLETED	8	8
Period 2, One Week of Wear NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Study n=16 Participants This reporting group includes all enrolled and dispensed subjects.
Age Continuous	48.3 years STANDARD_DEVIATION 4.5 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week of wear

Population: Analysis conducted per protocol

Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied.

Outcome measures

Outcome measures
Measure	Lotrafilcon B Multifocal Contact Lens n=16 Participants Commercially marketed, lotrafilcon B, silicone hydrogel, multifocal contact lens for daily wear use	Lotrafilcon B Single Vision Contact Lens + Reading Glasses n=16 Participants Commercially marketed, lotrafilcon B, silicone hydrogel, single vision contact lenses for daily wear use, with over-reader spectacles worn as needed
Overall Satisfaction With the Lenses	82.5 Units on a Scale Standard Deviation 14.5	64.4 Units on a Scale Standard Deviation 22.9

Adverse Events

Multifocal Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Single Vision Contact Lens

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

Priya Janakiraman, OD, FAAO / Head, Global Clinical Affairs

CIBA VISION

Phone: 1-800-241-7629

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee No distribution of trial-specific information without express written permission of director.
Publication restrictions are in place

Restriction type: OTHER