Myopia
Conditions
Brief summary
The purpose of this study is to compare lens surface characteristics and comfort between an experimental contact lens and a marketed contact lens.
Interventions
Experimental silicone hydrogel contact lens
DEVICEmarketed galyfilcon A lens
Marketed silicone hydrogel contact lens.
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* The subject must be at least 18 years of age and no more than 39 years of age. * The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of daily wear (DW) for a minimum of 1 month prior to the study) and willing to wear the study lenses on a daily wear basis (defined as a minimum of 6 hours of wear per day at least five days of the week) for the duration of the study. * The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 9.00D. * Any cylinder power must be ≤ -0.75D. * The subject must have visual acuity best correctable to 20/25+3 or better for each eye. * The subject must read and sign the Statement of Informed Consent. * The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion criteria
* Ocular or systemic allergies or disease which might interfere with contact lens wear. * Systemic disease or use of medication which might interfere with contact lens wear. * Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. * Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. * Any ocular infection. * Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * Pregnancy or lactation. * Diabetes. * Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). * Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Front Surface Deposits at Day 7 | Evaluated 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. |
| Lens Front Surface Deposits at Day 14 | Evaluated 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Reported Overall Lens Comfort at Day 7 | Evaluated 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). |
| Subject Reported Overall Lens Comfort at Day 14 | Evaluated 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). |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All enrolled subjects who have the demographic data and worn at least one study lens. | 183 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 1 (14 Days) | Lost to Follow-up | 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 1 (14 Days) | Withdrawal by Subject | 0 | 1 |
| Period 2 (14 Days) | Adverse Event | 0 | 1 |
| Period 2 (14 Days) | No time for the follow-up visit | 1 | 0 |
| Period 2 (14 Days) | Protocol Violation | 2 | 0 |
| Period 2 (14 Days) | Unsatisfactory lens fitting | 0 | 1 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 27.5 years STANDARD_DEVIATION 5.78 |
| Region of Enrollment United States | 183 participants |
| Sex: Female, Male Female | 128 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 181 |
| serious Total, serious adverse events | 0 / 181 |
Outcome results
Primary
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
Population: Analysis was conducted on subjects who successfully completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A Prototype Lens | Lens Front Surface Deposits at Day 14 | 1.61 dichtomized grading scale | Standard Deviation 0.681 |
| Marketed Galyfilcon A Lens | Lens Front Surface Deposits at Day 14 | 1.67 dichtomized grading scale | Standard Deviation 0.759 |
Primary
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
Population: Analysis was conducted on subjects who successfully completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A Prototype Lens | Lens Front Surface Deposits at Day 7 | 1.53 dichotomized grading scale | Standard Deviation 0.769 |
| Marketed Galyfilcon A Lens | Lens Front Surface Deposits at Day 7 | 1.53 dichotomized grading scale | Standard Deviation 0.715 |
Secondary
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
Population: Analysis was conducted on subjects who successfully completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A Prototype Lens | Subject Reported Overall Lens Comfort at Day 14 | 57.3230 CLUE points | Standard Error 2.479 |
| Marketed Galyfilcon A Lens | Subject Reported Overall Lens Comfort at Day 14 | 55.4675 CLUE points | Standard Error 2.4694 |
Secondary
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
Population: Analysis was conducted on subjects who successfully completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Galyfilcon A Prototype Lens | Subject Reported Overall Lens Comfort at Day 7 | 60.7787 CLUE points | Standard Error 2.3993 |
| Marketed Galyfilcon A Lens | Subject Reported Overall Lens Comfort at Day 7 | 59.3206 CLUE points | Standard Error 2.385 |