An interventional study of galyfilcon A prototype lens and marketed galyfilcon A lens in Myopia, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2018-06-19.
Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment
The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's enrollment of 185 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The galyfilcon A prototype lens worn daily for 12-16 days during the first period then the marketed galyfilcon A lens worn daily for 12-16 days during the second period.
Device: galyfilcon A prototype lens · Device: marketed galyfilcon A lens
The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period; during each period.
Device: galyfilcon A prototype lens · Device: marketed galyfilcon A lens
Experimental silicone hydrogel contact lens
Marketed silicone hydrogel contact lens.
Also known as: ACUVUE(R) ADVANCE(TM)
Lens Front Surface Deposits at Day 7
Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.
Time frame: Evaluated at Day 7
Lens Front Surface Deposits at Day 14
Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.
Time frame: Evaluated at Day 14
Subject Reported Overall Lens Comfort at Day 7
The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE 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. 97% of the scores fall within 0 and 120 (mean +/-3\*SD).
Time frame: Evaluated at Day 7
Subject Reported Overall Lens Comfort at Day 14
The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE 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. 97% of the scores fall within 0 and 120 (mean +/-3\*SD).
Time frame: Evaluated at Day 14
| Milestone | Galyfilcon A Prototype/Marketed Galyfilcon A | Marketed Galyfilcon A/Galyfilcon A Prototype |
|---|---|---|
| Started | 92 | 88 |
| Completed | 90 | 86 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: No time for the follow-up visit | 1 | 0 |
| Withdrew: Unsatisfactory visual response | 1 | 0 |
| Milestone | Galyfilcon A Prototype/Marketed Galyfilcon A | Marketed Galyfilcon A/Galyfilcon A Prototype |
|---|---|---|
| Started | 90 | 86 |
| Completed | 87 | 84 |
| Not completed | 3 | 2 |
| Withdrew: Protocol violation | 2 | 0 |
| Withdrew: No time for the follow-up visit | 1 | 0 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Unsatisfactory lens fitting | 0 | 1 |
Deposits on the front surface of each lens were examined by the investigator after 7 days of lens wear, and graded on a 5-point scale; 0 = no deposit, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3 = 16%-25% deposits, and 4 = 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 Vs. grade 2 or higher.
| dichotomized grading scale | Galyfilcon A Prototype Lens | Marketed Galyfilcon A Lens |
|---|---|---|
| Lens Front Surface Deposits at Day 7 | 1.53 ± 0.769 | 1.53 ± 0.715 |
The overall lens comfort was assessed at Day 7 using the Contact Lens User Experience (CLUE) questionnaire. CLUE 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. 97% of the scores fall within 0 and 120 (mean +/-3\*SD).
| CLUE points | Galyfilcon A Prototype Lens | Marketed Galyfilcon A Lens |
|---|---|---|
| Subject Reported Overall Lens Comfort at Day 7 | 60.7787 ± 2.3993 | 59.3206 ± 2.3850 |
Deposits on the front surface of each lens were examined by the investigator after 14 days of lens wear, and graded on a 5-point scale; 0 = 0% deposits, 1 = 1%-5% deposits, 2 = 6%-15% deposits, 3=16%-25% deposits, and 4= 25% or more deposits. The grades were categorized into binary variable: grade 0 or 1 vs. grade 2 or higher.
| dichtomized grading scale | Galyfilcon A Prototype Lens | Marketed Galyfilcon A Lens |
|---|---|---|
| Lens Front Surface Deposits at Day 14 | 1.61 ± 0.681 | 1.67 ± 0.759 |
The overall lens comfort was assessed at Day 14 using the CLUE questionnaire. CLUE 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. 97% of the scores fall within 0 and 120 (mean +/-3\*SD).
| CLUE points | Galyfilcon A Prototype Lens | Marketed Galyfilcon A Lens |
|---|---|---|
| Subject Reported Overall Lens Comfort at Day 14 | 57.3230 ± 2.4790 | 55.4675 ± 2.4694 |
Collected over Adverse events were recorded when the subjects were exposed to the Investigational lenses.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects | — | 0/181 (0%) | 0/181 (0%) |
Baseline summary was conducted on all enrolled subjects who have the demographic data. Two enrolled subjects were excluded from the Baseline summary for age and gender categories due to missing demographic data, reducing the count from 185 to 183; one subject was ineligible and the other one withdrew their consent.
| Age, Continuous(years) | All Subjects |
|---|---|
| Mean | 27.5 ± 5.78 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 128 |
| Male | 55 |
| Region of Enrollment(participants) | All Subjects |
|---|---|
| United States | 183 |
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johnson & Johnson Vision Care, Inc.