Trial Outcomes & Findings for Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens (NCT NCT01180985)

NCT ID: NCT01180985

Last Updated: 2018-06-19

Results Overview

Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 53 participants
• Primary outcome timeframe: after 7 +/- 1 days of lens wear
• Results posted on: 2018-06-19

Participant Flow

This study was a four (4) site, bilateral crossover study. Data were collected in three (3) visits (initial, 1 wk follow-up, and final visit).

Fifty-three (53) subjects enrolled, one(1) subject was discontinued and fifty-two (52) completed the study.

Participant milestones

Measure	Galyfilcon A (Test)/Comfilcon A (Control) Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.	Comfilcon A (Control)/Galyfilcon A (Test) Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
Period 1 (7 +/- Days) STARTED	27	26
Period 1 (7 +/- Days) COMPLETED	27	26
Period 1 (7 +/- Days) NOT COMPLETED	0	0
Period 2 (7 +/- 1 Days) STARTED	27	26
Period 2 (7 +/- 1 Days) COMPLETED	26	26
Period 2 (7 +/- 1 Days) NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Galyfilcon A (Test)/Comfilcon A (Control) Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.	Comfilcon A (Control)/Galyfilcon A (Test) Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
Period 2 (7 +/- 1 Days) Lost to Follow-up	1	0

Baseline Characteristics

Dispensing Evaluation of a Galyfilcon A Prototype Lens and a Marketed Contact Lens

Baseline characteristics by cohort

Measure	All Subjects n=53 Participants All enrolled subjects at baseline.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	28.00 years STANDARD_DEVIATION 5.82 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants

PRIMARY outcome

Timeframe: after 7 +/- 1 days of lens wear

Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

Snellen monocular visual acuity measurement was measured in both eyes that wore lenses for one week and came in for the evaluation with an inserted lens.

Outcome measures

Measure	Comfilcon A Lens (Control) n=104 eyes All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation	Galyfilcon A Lens (Test) n=104 eyes All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
Visual Acuity Monocular 20/15 monocular	53 eyes	49 eyes
Visual Acuity Monocular 20/20 monocular	49 eyes	48 eyes
Visual Acuity Monocular 20/25 monocular	2 eyes	4 eyes
Visual Acuity Monocular 20/30 monocular	0 eyes	3 eyes

PRIMARY outcome

Timeframe: after 7 +/- 1 days of lens wear

Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

Snellen binocular visual acuity measurement

Outcome measures

Measure	Comfilcon A Lens (Control) n=52 Participants All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation	Galyfilcon A Lens (Test) n=52 Participants All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
Visual Acuity Binocular 20/10 binocular	0 participants	1 participants
Visual Acuity Binocular 20/15 binocular	31 participants	29 participants
Visual Acuity Binocular 20/20 binocular	21 participants	20 participants
Visual Acuity Binocular 20/25 binocular	0 participants	1 participants
Visual Acuity Binocular 20/30 binocular	0 participants	1 participants

PRIMARY outcome

Timeframe: after 7 +/-1 days of lens wear

Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

The contract Lens Experience (CLUE)TM questionnaire is a validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.

Outcome measures

Measure	Comfilcon A Lens (Control) n=50 Participants All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation	Galyfilcon A Lens (Test) n=50 Participants All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.	57.72 CLUE score Standard Error 4.47	67.06 CLUE score Standard Error 4.50

PRIMARY outcome

Timeframe: after 7 +/- 1 days of lens wear

Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.

Outcome measures

Measure	Comfilcon A Lens (Control) n=50 Participants All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation	Galyfilcon A Lens (Test) n=50 Participants All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.	62.75 CLUE score Standard Error 2.83	59.98 CLUE score Standard Error 2.81

SECONDARY outcome

Timeframe: after 7 days of lens wear

Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

Outcome measures

Measure	Comfilcon A Lens (Control) n=104 eyes All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation	Galyfilcon A Lens (Test) n=104 eyes All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
Limbal Redness Grade 0 = No redness	37 eyes	36 eyes
Limbal Redness Grade 1 = Trace redness	36 eyes	42 eyes
Limbal Redness Grade 2 = Mild redness	31 eyes	26 eyes

SECONDARY outcome

Timeframe: after 7 days of lens wear

Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.

Outcome measures

Measure	Comfilcon A Lens (Control) n=104 eyes All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation	Galyfilcon A Lens (Test) n=104 eyes All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
Bulbar Redness Grade 0 = No redness	39 eyes	37 eyes
Bulbar Redness Grade 1 = Trace redness	55 eyes	59 eyes
Bulbar Redness Grade 2 = Mild redness	10 eyes	8 eyes

SECONDARY outcome

Timeframe: 10 minutes after lens insertion at time of initial lens fitting

Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.

Contact Lens User Experience CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population 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.

Outcome measures

Measure	Comfilcon A Lens (Control) n=50 Participants All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation	Galyfilcon A Lens (Test) n=50 Participants All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.	80.32 CLUE score Standard Deviation 18.36	82.76 CLUE score Standard Deviation 17.01

Adverse Events

Galyfilcon A Prototype/Comfilcon A

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

John Buch, OD, MS, FAAO

Johnson & Johnson Vision Care

Phone: 1 904 443-1707

Email: jbuch@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee Publication requires agreement and written consent from the Sponsor.
• Publication restrictions are in place

Restriction type: OTHER