Trial Outcomes & Findings for A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens (NCT NCT01539694)

NCT ID: NCT01539694

Last Updated: 2020-09-30

Results Overview

Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Recruitment status

COMPLETED

Study phase

Target enrollment

126 participants

Primary outcome timeframe

At 1 week follow up

Results posted on

2020-09-30

Participant Flow

A total of 126 participants (252 eyes) were enrolled. One-half of the participants were randomized to receive the investigational contact lens during the first crossover period, and the other half were randomized to receive the PureVision contact lens during the first crossover period. The participants crossed over to the other group at 1 week.

Participant milestones

Participant milestones
Measure	LD118033 Contact Lens Then PureVision Multifocal Contact Lens Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week	PureVision Multifocal Contact Lens Then LD118033 Contact Lens PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week. Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week
Overall Study STARTED	63	63
Overall Study COMPLETED	62	62
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Product Performance of a Low Add MultiFocal Soft Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=124 Participants All participants/eyes received both treatment groups.
Age, Continuous	47.0 years STANDARD_DEVIATION 4.7 • n=5 Participants
Sex: Female, Male Female	93 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 week follow up

Population: There were 124 eligible, dispensed participants (248 eyes). Participants/eyes received both treatment groups.

Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Outcome measures

Outcome measures
Measure	LD118033 Contact Lens n=248 eyes Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week	PureVision Multifocal Contact Lens n=248 eyes PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week.
Visual Acuity	0.023 logMAR Standard Deviation 0.078	0.005 logMAR Standard Deviation 0.069

SECONDARY outcome

Timeframe: At 1 week follow up

Population: There were 124 eligible, dispensed participants (248 eyes). Participants/eyes received both treatment groups.

Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.

Outcome measures

Outcome measures
Measure	LD118033 Contact Lens n=248 eyes Investigational LD118033 multifocal low add soft contact lenses, to be worn on a daily wear basis. LD118033 contact lens: Multifocal contact lens worn on a daily wear basis for 1 week	PureVision Multifocal Contact Lens n=248 eyes PureVision multifocal low add soft contact lens, to be worn on a daily wear basis. PureVision multifocal contact lens: PureVision multifocal contact lens worn on a daily wear basis for 1 week.
Symptoms/Complaints Burning/stinging upon insertion	91.3 score on a scale Standard Deviation 12.6	89.2 score on a scale Standard Deviation 16.9
Symptoms/Complaints Comfort upon insertion	87.0 score on a scale Standard Deviation 16.6	83.9 score on a scale Standard Deviation 18.0
Symptoms/Complaints Comfort at end of day	72.5 score on a scale Standard Deviation 24.4	68.1 score on a scale Standard Deviation 25.0
Symptoms/Complaints Overall comfort	79.2 score on a scale Standard Deviation 21.2	74.6 score on a scale Standard Deviation 22.9
Symptoms/Complaints Dryness	78.7 score on a scale Standard Deviation 22.4	75.2 score on a scale Standard Deviation 23.7
Symptoms/Complaints Itchiness	89.1 score on a scale Standard Deviation 17.0	84.5 score on a scale Standard Deviation 21.1
Symptoms/Complaints Redness	91.9 score on a scale Standard Deviation 12.3	87.0 score on a scale Standard Deviation 18.0
Symptoms/Complaints Distance Vision	69.3 score on a scale Standard Deviation 30.4	76.5 score on a scale Standard Deviation 23.3
Symptoms/Complaints Vision at intermediate distance	81.2 score on a scale Standard Deviation 20.3	80.7 score on a scale Standard Deviation 18.3
Symptoms/Complaints Vision at near distance	76.3 score on a scale Standard Deviation 25.7	72.2 score on a scale Standard Deviation 26.2
Symptoms/Complaints Overall vision	72.9 score on a scale Standard Deviation 25.8	73.7 score on a scale Standard Deviation 22.7
Symptoms/Complaints Ease of handling/insertion	85.7 score on a scale Standard Deviation 18.8	85.4 score on a scale Standard Deviation 19.7
Symptoms/Complaints Ease of handling/removal	88.5 score on a scale Standard Deviation 17.2	87.5 score on a scale Standard Deviation 17.5
Symptoms/Complaints Overall impression	24.7 score on a scale Standard Deviation 24.0	74.6 score on a scale Standard Deviation 22.7

Adverse Events

LD118033 Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PureVision Multifocal 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

Study Director

Bausch Health

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Contact sponsor directly for details.
Publication restrictions are in place

Restriction type: OTHER