Trial Outcomes & Findings for A Study to Evaluate a Mid Add Multi-Focal Soft Contact Lens (NCT NCT01959178)

NCT ID: NCT01959178

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

146 participants

Primary outcome timeframe

At 1 Week follow up

Results posted on

2020-09-30

Participant Flow

There were 146 participants (292 eyes) were enrolled in this study. One-half of the participants were randomized to receive the investigational lens, and the other half to the control lens. After one week, the participant crossed over to the second lens type for one week.

Participant milestones

Participant milestones
Measure	LD127025 MF Then Air Optix Aqua MF LD127025 MF and then Air Optix Aqua MF after 1 week	Air Optix Aqua MF Then LD127025 MF Air Optix Aqua MF and then LD127025 MF after 1 week
Overall Study STARTED	73	73
Overall Study COMPLETED	71	71
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate a Mid Add Multi-Focal Soft Contact Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Overall Enrolled n=145 Participants Overall participants enrolled.
Age, Continuous	48.2 years STANDARD_DEVIATION 5.3 • n=5 Participants
Sex: Female, Male Female	110 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: At 1 Week follow up

Population: Eligible, dispensed eyes assessed for visual acuity are included in the analysis population.

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

Outcome measures

Outcome measures
Measure	LD127025 MF n=143 Participants Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week.	Air Optix Aqua MF n=288 eyes Medium add daily disposable soft contact lens worn on a daily wear basis for one week.
Mean Visual Acuity	-0.026 logMAR Standard Deviation 0.070	0.008 logMAR Standard Deviation 0.078

SECONDARY outcome

Timeframe: At 1 Week follow up

Population: Eligible, dispensed eyes assessed for symptoms/complaints are included in the analysis population.

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

Outcome measures

Outcome measures
Measure	LD127025 MF n=286 eyes Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week.	Air Optix Aqua MF n=282 eyes Medium add daily disposable soft contact lens worn on a daily wear basis for one week.
Symptoms/Complaints Distance vision	91.0 score on a scale Standard Deviation 16.1	82.0 score on a scale Standard Deviation 21.1
Symptoms/Complaints Burning/stinging upon insertion	96.1 score on a scale Standard Deviation 9.8	93.4 score on a scale Standard Deviation 11.8
Symptoms/Complaints Comfort upon insertion	95.4 score on a scale Standard Deviation 8.3	91.4 score on a scale Standard Deviation 12.6
Symptoms/Complaints Comfort at end of day	83.7 score on a scale Standard Deviation 19.5	79.9 score on a scale Standard Deviation 20.7
Symptoms/Complaints Overall comfort	88.3 score on a scale Standard Deviation 16.4	84.6 score on a scale Standard Deviation 17.4
Symptoms/Complaints Ease of handling/insertion	92.3 score on a scale Standard Deviation 13.3	93.5 score on a scale Standard Deviation 9.6
Symptoms/Complaints Ease of handling/removal	89.3 score on a scale Standard Deviation 16.5	93.6 score on a scale Standard Deviation 9.7
Symptoms/Complaints Dryness	86.1 score on a scale Standard Deviation 18.2	85.6 score on a scale Standard Deviation 16.9
Symptoms/Complaints Itchiness	94.4 score on a scale Standard Deviation 10.3	90.2 score on a scale Standard Deviation 15.1
Symptoms/Complaints Redness	95.3 score on a scale Standard Deviation 7.6	91.0 score on a scale Standard Deviation 13.9
Symptoms/Complaints Overall impression	84.1 score on a scale Standard Deviation 19.7	83.3 score on a scale Standard Deviation 19.9
Symptoms/Complaints Vision at intermediate distance	80.8 score on a scale Standard Deviation 21.8	84.4 score on a scale Standard Deviation 16.3
Symptoms/Complaints Vision at near distance	60.1 score on a scale Standard Deviation 28.6	76.1 score on a scale Standard Deviation 22.6
Symptoms/Complaints Overall vision	74.0 score on a scale Standard Deviation 23.0	79.5 score on a scale Standard Deviation 19.9

Adverse Events

LD127025 MF

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Air Optix Aqua MF

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