Trial Outcomes & Findings for A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens (NCT NCT01518868)

NCT ID: NCT01518868

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 2 weeks 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	Investigational Contact Lens Then PureVision Contact Lens multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week. Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis for one week	PureVision Contact Lens Multi-focal contact lens then Investigational Contact Lens PureVision contact lens: Worn on a daily wear basis for one week multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week.
Overall Study STARTED	63	63
Overall Study COMPLETED	59	59
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall n=124 Participants Participants received both treatment groups in this cross-over study.
Age, Continuous	51.6 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 2 weeks follow up

Population: There were 238 eyes assessed for visual acuity for this outcome measure. 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	Investigational Contact Lens n=238 eye multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week.	PureVision Contact Lens n=238 eye Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis for one week
Visual Acuity	0.079 logMAR Standard Deviation 0.102	0.090 logMAR Standard Deviation 0.091

SECONDARY outcome

Timeframe: At 2 weeks follow up

Population: There were 238 eyes assessed for symptoms/complaints for this outcome measure. 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	Investigational Contact Lens n=238 eyes multifocal high add soft contact lens Investigational contact lens: Worn on a daily wear basis for one week.	PureVision Contact Lens n=238 eyes Multi-focal contact lens PureVision contact lens: Worn on a daily wear basis for one week
Symptoms/Complaints Overall impression	73.3 score on a scale Standard Deviation 23.5	61.1 score on a scale Standard Deviation 29.9
Symptoms/Complaints Burning/stinging upon insertion	95.6 score on a scale Standard Deviation 8.9	92.5 score on a scale Standard Deviation 14.7
Symptoms/Complaints Comfort upon insertion	89.4 score on a scale Standard Deviation 17.0	81.5 score on a scale Standard Deviation 25.0
Symptoms/Complaints Comfort at end of day	75.3 score on a scale Standard Deviation 25.4	64.9 score on a scale Standard Deviation 28.8
Symptoms/Complaints Overall comfort	81.6 score on a scale Standard Deviation 20.3	70.5 score on a scale Standard Deviation 26.7
Symptoms/Complaints Dryness	80.3 score on a scale Standard Deviation 20.3	73.3 score on a scale Standard Deviation 26.4
Symptoms/Complaints Itchiness	91.9 score on a scale Standard Deviation 13.8	86.8 score on a scale Standard Deviation 22.1
Symptoms/Complaints Redness	91.4 score on a scale Standard Deviation 14.4	86.9 score on a scale Standard Deviation 23.0
Symptoms/Complaints Distance vision	67.7 score on a scale Standard Deviation 29.8	59.3 score on a scale Standard Deviation 30.8
Symptoms/Complaints Vision at intermediate distance	80.5 score on a scale Standard Deviation 22.5	70.3 score on a scale Standard Deviation 25.8
Symptoms/Complaints Vision at near distance	65.0 score on a scale Standard Deviation 30.0	58.8 score on a scale Standard Deviation 30.8
Symptoms/Complaints Overall vision	66.7 score on a scale Standard Deviation 25.4	56.2 score on a scale Standard Deviation 27.5
Symptoms/Complaints Ease of handling/insertion	86.5 score on a scale Standard Deviation 20.4	84.3 score on a scale Standard Deviation 21.7
Symptoms/Complaints Ease of handling/removal	88.6 score on a scale Standard Deviation 16.3	86.2 score on a scale Standard Deviation 19.6

Adverse Events

Investigational Contact Lens

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PureVision 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