Trial Outcomes & Findings for Pilot Dispensing Evaluation of a Plus Power Lens (NCT NCT01228591)

Results Overview

Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

38 participants

Primary outcome timeframe

1 week

Results posted on

2018-06-19

Participant Flow

This is a 3 site, 3 visit, randomized, double-masked, bilateral crossover trial comparing Acuvue Advance to Acuvue Advance Plus lenses.

Of the 38 subjects enrolled, 2 were ineligible and not-randomized, 3 discontinued, and 33 completed as cohort.

Participant milestones

Participant milestones
Measure	Acuvue Advance Plus/ Acuvue Advance Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second	Acuvue Advance/ Acuvue Advance Plus Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
Baseline STARTED	18	18
Baseline COMPLETED	17	16
Baseline NOT COMPLETED	1	2
1-Week Follow-Up STARTED	17	16
1-Week Follow-Up COMPLETED	17	16
1-Week Follow-Up NOT COMPLETED	0	0
Final Visit STARTED	17	16
Final Visit COMPLETED	17	16
Final Visit NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Acuvue Advance Plus/ Acuvue Advance Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second	Acuvue Advance/ Acuvue Advance Plus Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
Baseline Lack of Efficacy	1	2

Baseline Characteristics

Pilot Dispensing Evaluation of a Plus Power Lens

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=33 Participants Subjects who were randomized and successfully completed the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	29.8 years STANDARD_DEVIATION 5.66 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: Subjects analyzed were those who were enrolled, randomized, and completed the study. Both monocular and binocular measurements were taken and included in analysis.

Visual acuity was measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study. Binocular and monocular measurements were collected.

Outcome measures

Outcome measures
Measure	Acuvue Advance Plus n=66 eyes Acuvue Advance Plus contact lenses-Binocular measurements	Acuvue Advance n=66 eyes Acuvue Advance contact lenses - Binocular Measurements
Visual Acuity One Week After Lens Wear Low Luminance/ High Contrast (Binocular)	0.11 LogMAR Standard Error 0.082	0.10 LogMAR Standard Error 0.063
Visual Acuity One Week After Lens Wear High Luminance/ Low Contrast (Binocular)	0.12 LogMAR Standard Error 0.075	0.13 LogMAR Standard Error 0.067
Visual Acuity One Week After Lens Wear High Luminance/ Low Contrast (Monocular)	0.22 LogMAR Standard Error 0.108	0.21 LogMAR Standard Error 0.097
Visual Acuity One Week After Lens Wear Low Luminance/ High Contrast (Monocular)	0.14 LogMAR Standard Error 0.100	0.14 LogMAR Standard Error 0.088

PRIMARY outcome

Timeframe: After 10-15 minutes of lens wear

Population: Analysis is conducted on those were enrolled and completed the trial.

Visual acuity will be measured using ETDRS visual acuity test. ETDRS stands for Early Treatment Diabetic Retinopathy Study.

Outcome measures

Outcome measures
Measure	Acuvue Advance Plus n=66 eyes Acuvue Advance Plus contact lenses-Binocular measurements	Acuvue Advance n=66 eyes Acuvue Advance contact lenses - Binocular Measurements
Visual Acuity at Time of Initial Fit Low Luminance/High Contrast (Binocular)	0.13 LogMAR Standard Deviation 0.087	0.11 LogMAR Standard Deviation 0.073
Visual Acuity at Time of Initial Fit Low Luminance/High Contrast (Monocular)	0.16 LogMAR Standard Deviation 0.106	0.15 LogMAR Standard Deviation 0.101
Visual Acuity at Time of Initial Fit High Luminance/Low Contrast (Binocular)	0.14 LogMAR Standard Deviation 0.076	0.13 LogMAR Standard Deviation 0.094
Visual Acuity at Time of Initial Fit High Luminance/Low Contrast (Monocular)	0.24 LogMAR Standard Deviation 0.123	0.21 LogMAR Standard Deviation 0.111

SECONDARY outcome

Timeframe: 1 week

Population: Analysis was on those who were enrolled and completed the study.

The subjective comfort questionnaire CLUE, assesses the overall lens comfort. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.

Outcome measures

Outcome measures
Measure	Acuvue Advance Plus n=33 Participants Acuvue Advance Plus contact lenses-Binocular measurements	Acuvue Advance n=33 Participants Acuvue Advance contact lenses - Binocular Measurements
Contact Lens Comfort Using Contact Lens User Experience (CLUE)	49.2 CLUE points Standard Error 3.28	50.7 CLUE points Standard Error 3.26

SECONDARY outcome

Timeframe: 1 week

Population: Analysis was on those who were enrolled and completed the study.

Overall vision was assessed by a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.

Outcome measures

Outcome measures
Measure	Acuvue Advance Plus n=33 Participants Acuvue Advance Plus contact lenses-Binocular measurements	Acuvue Advance n=33 Participants Acuvue Advance contact lenses - Binocular Measurements
Subject Reported Vision Using Contact Lens User Experience (CLUE).	42.5 CLUE points Standard Error 2.87	39.9 CLUE points Standard Error 2.86

SECONDARY outcome

Timeframe: Baseline

Population: Analysis was on those who were enrolled and completed the study.

Comfort was assessed using a subjective comfort questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. CLUE scores have a range of 0-120.

Outcome measures

Outcome measures
Measure	Acuvue Advance Plus n=33 Participants Acuvue Advance Plus contact lenses-Binocular measurements	Acuvue Advance n=33 Participants Acuvue Advance contact lenses - Binocular Measurements
Contact Lens Comfort at Initial Fit Using Contact Lens User Experience (CLUE)	65.3 CLUE points Standard Error 3.14	59.0 CLUE points Standard Error 3.19

SECONDARY outcome

Timeframe: Baseline

Population: Subjects analyzed included only those who were enrolled and completed the study.

Vision at initial fit was assessed using a subjective vision questionnaire. The CLUE Questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120.

Outcome measures

Outcome measures
Measure	Acuvue Advance Plus n=33 Participants Acuvue Advance Plus contact lenses-Binocular measurements	Acuvue Advance n=33 Participants Acuvue Advance contact lenses - Binocular Measurements
Subject Reported Vision at Initial Fit Using Contact Lens User Experience (CLUE)	46.7 CLUE points Standard Error 3.90	49.6 CLUE points Standard Error 3.98

Adverse Events

Acuvue Advance Plus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Acuvue Advance

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

Brian Pall, O.D., M.S., F.A.A.O. Principal Research Optometrist

Johnson & Johnson Vision Care

Phone: 1 904 443-1290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60