Trial Outcomes & Findings for Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens (NCT NCT01094730)
NCT ID: NCT01094730
Last Updated: 2018-06-19
Results Overview
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.
COMPLETED
NA
185 participants
Evaluated at Day 7
2018-06-19
Participant Flow
There were five subjects enrolled who were not randomized to a study arm due to exclusion criteria dropping the study enrollment from 185 to 180.
Participant milestones
| Measure |
Galyfilcon A Prototype/Marketed Galyfilcon A
The galyfilcon A prototype lens worn daily for 12-16 days during the first period then marketed galyfilcon A lens worn daily for 12-16 days during the second period.
|
Marketed Galyfilcon A/Galyfilcon A Prototype
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.
|
|---|---|---|
|
Period 1 (14 Days)
STARTED
|
92
|
88
|
|
Period 1 (14 Days)
COMPLETED
|
90
|
86
|
|
Period 1 (14 Days)
NOT COMPLETED
|
2
|
2
|
|
Period 2 (14 Days)
STARTED
|
90
|
86
|
|
Period 2 (14 Days)
COMPLETED
|
87
|
84
|
|
Period 2 (14 Days)
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Galyfilcon A Prototype/Marketed Galyfilcon A
The galyfilcon A prototype lens worn daily for 12-16 days during the first period then marketed galyfilcon A lens worn daily for 12-16 days during the second period.
|
Marketed Galyfilcon A/Galyfilcon A Prototype
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.
|
|---|---|---|
|
Period 1 (14 Days)
Lost to Follow-up
|
0
|
1
|
|
Period 1 (14 Days)
Withdrawal by Subject
|
0
|
1
|
|
Period 1 (14 Days)
No time for the follow-up visit
|
1
|
0
|
|
Period 1 (14 Days)
Unsatisfactory visual response
|
1
|
0
|
|
Period 2 (14 Days)
Protocol Violation
|
2
|
0
|
|
Period 2 (14 Days)
No time for the follow-up visit
|
1
|
0
|
|
Period 2 (14 Days)
Adverse Event
|
0
|
1
|
|
Period 2 (14 Days)
Unsatisfactory lens fitting
|
0
|
1
|
Baseline Characteristics
Pilot Evaluation of a New Galyfilcon A Contact Lens Compared to a Marketed Galyfilcon A Contact Lens
Baseline characteristics by cohort
| Measure |
All Subjects
n=183 Participants
All enrolled subjects who have the demographic data and worn at least one study lens.
|
|---|---|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 5.78 • n=39 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
183 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Evaluated at Day 7Population: Analysis was conducted on subjects who successfully completed the study.
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.
Outcome measures
| Measure |
Galyfilcon A Prototype Lens
n=341 eyes
Experimental silicone hydrogel contact lens.
|
Marketed Galyfilcon A Lens
n=338 eyes
Marketed silicone hydrogel contact lens.
|
|---|---|---|
|
Lens Front Surface Deposits at Day 7
|
1.53 dichotomized grading scale
Standard Deviation 0.769
|
1.53 dichotomized grading scale
Standard Deviation 0.715
|
PRIMARY outcome
Timeframe: Evaluated at Day 14Population: Analysis was conducted on subjects who successfully completed the study.
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.
Outcome measures
| Measure |
Galyfilcon A Prototype Lens
n=338 Contact Lenses
Experimental silicone hydrogel contact lens.
|
Marketed Galyfilcon A Lens
n=340 Contact Lenses
Marketed silicone hydrogel contact lens.
|
|---|---|---|
|
Lens Front Surface Deposits at Day 14
|
1.61 dichtomized grading scale
Standard Deviation 0.681
|
1.67 dichtomized grading scale
Standard Deviation 0.759
|
SECONDARY outcome
Timeframe: Evaluated at Day 7Population: Analysis was conducted on subjects who successfully completed the study.
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).
Outcome measures
| Measure |
Galyfilcon A Prototype Lens
n=170 Participants
Experimental silicone hydrogel contact lens.
|
Marketed Galyfilcon A Lens
n=170 Participants
Marketed silicone hydrogel contact lens.
|
|---|---|---|
|
Subject Reported Overall Lens Comfort at Day 7
|
60.7787 CLUE points
Standard Error 2.3993
|
59.3206 CLUE points
Standard Error 2.3850
|
SECONDARY outcome
Timeframe: Evaluated at Day 14Population: Analysis was conducted on subjects who successfully completed the study.
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).
Outcome measures
| Measure |
Galyfilcon A Prototype Lens
n=169 Participants
Experimental silicone hydrogel contact lens.
|
Marketed Galyfilcon A Lens
n=169 Participants
Marketed silicone hydrogel contact lens.
|
|---|---|---|
|
Subject Reported Overall Lens Comfort at Day 14
|
57.3230 CLUE points
Standard Error 2.4790
|
55.4675 CLUE points
Standard Error 2.4694
|
Adverse Events
All Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John R. Buch, O.D., M.S., F.A.A.O., Principal Research Optometrist
Johnson & Johnson Vision Care
Results disclosure agreements
- Principal investigator is a sponsor employee Publication requires the agreement and written authorization of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER