Myopia
Conditions
Brief summary
The purpose of this study is to compare visual acuity and redness of eyes between a prototype contact lens and an already marketed contact lens.
Interventions
silicone hydrogel contact lens
DEVICEcomfilcon A
silicone hydrogel contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study. * The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D. * 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 the 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 |
|---|---|---|
| Visual Acuity Monocular | after 7 +/- 1 days of lens wear | 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. |
| Visual Acuity Binocular | after 7 +/- 1 days of lens wear | Snellen binocular visual acuity measurement |
| Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | after 7 +/-1 days of lens wear | 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. |
| Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire. | after 7 +/- 1 days of lens wear | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bulbar Redness | after 7 days of lens wear | Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe. |
| Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | 10 minutes after lens insertion at time of initial lens fitting | 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. |
| Limbal Redness | after 7 days of lens wear | Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
Fifty-three (53) subjects enrolled, one(1) subject was discontinued and fifty-two (52) completed the study.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All enrolled subjects at baseline. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 (7 +/- 1 Days) | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants |
| Age, Continuous | 28.00 years STANDARD_DEVIATION 5.82 |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Lens (Control) | Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | 57.72 CLUE score | Standard Error 4.47 |
| Galyfilcon A Lens (Test) | Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | 67.06 CLUE score | Standard Error 4.5 |
Primary
Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire.
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Lens (Control) | Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire. | 62.75 CLUE score | Standard Error 2.83 |
| Galyfilcon A Lens (Test) | Subjective Assessment of Quality of Vision Using the Contact Lens User Experience(CLUE)TM Questionnaire. | 59.98 CLUE score | Standard Error 2.81 |
Primary
Visual Acuity Binocular
Snellen binocular visual acuity measurement
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A Lens (Control) | Visual Acuity Binocular | 20/15 binocular | 31 participants |
| Comfilcon A Lens (Control) | Visual Acuity Binocular | 20/25 binocular | 0 participants |
| Comfilcon A Lens (Control) | Visual Acuity Binocular | 20/20 binocular | 21 participants |
| Comfilcon A Lens (Control) | Visual Acuity Binocular | 20/30 binocular | 0 participants |
| Comfilcon A Lens (Control) | Visual Acuity Binocular | 20/10 binocular | 0 participants |
| Galyfilcon A Lens (Test) | Visual Acuity Binocular | 20/30 binocular | 1 participants |
| Galyfilcon A Lens (Test) | Visual Acuity Binocular | 20/10 binocular | 1 participants |
| Galyfilcon A Lens (Test) | Visual Acuity Binocular | 20/15 binocular | 29 participants |
| Galyfilcon A Lens (Test) | Visual Acuity Binocular | 20/20 binocular | 20 participants |
| Galyfilcon A Lens (Test) | Visual Acuity Binocular | 20/25 binocular | 1 participants |
Primary
Visual Acuity Monocular
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A Lens (Control) | Visual Acuity Monocular | 20/15 monocular | 53 eyes |
| Comfilcon A Lens (Control) | Visual Acuity Monocular | 20/20 monocular | 49 eyes |
| Comfilcon A Lens (Control) | Visual Acuity Monocular | 20/25 monocular | 2 eyes |
| Comfilcon A Lens (Control) | Visual Acuity Monocular | 20/30 monocular | 0 eyes |
| Galyfilcon A Lens (Test) | Visual Acuity Monocular | 20/30 monocular | 3 eyes |
| Galyfilcon A Lens (Test) | Visual Acuity Monocular | 20/15 monocular | 49 eyes |
| Galyfilcon A Lens (Test) | Visual Acuity Monocular | 20/25 monocular | 4 eyes |
| Galyfilcon A Lens (Test) | Visual Acuity Monocular | 20/20 monocular | 48 eyes |
Secondary
Bulbar Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time frame: after 7 days of lens wear
Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A Lens (Control) | Bulbar Redness | Grade 0 = No redness | 39 eyes |
| Comfilcon A Lens (Control) | Bulbar Redness | Grade 1 = Trace redness | 55 eyes |
| Comfilcon A Lens (Control) | Bulbar Redness | Grade 2 = Mild redness | 10 eyes |
| Galyfilcon A Lens (Test) | Bulbar Redness | Grade 0 = No redness | 37 eyes |
| Galyfilcon A Lens (Test) | Bulbar Redness | Grade 1 = Trace redness | 59 eyes |
| Galyfilcon A Lens (Test) | Bulbar Redness | Grade 2 = Mild redness | 8 eyes |
Secondary
Limbal Redness
Scale of 0 to 4, where 0=None, 2=Trace, 3=Mild, 4=Moderate, 5=Severe.
Time frame: after 7 days of lens wear
Population: Analysis is on those subjects who were enrolled, randomized to a study arm, and completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A Lens (Control) | Limbal Redness | Grade 0 = No redness | 37 eyes |
| Comfilcon A Lens (Control) | Limbal Redness | Grade 1 = Trace redness | 36 eyes |
| Comfilcon A Lens (Control) | Limbal Redness | Grade 2 = Mild redness | 31 eyes |
| Galyfilcon A Lens (Test) | Limbal Redness | Grade 0 = No redness | 36 eyes |
| Galyfilcon A Lens (Test) | Limbal Redness | Grade 1 = Trace redness | 42 eyes |
| Galyfilcon A Lens (Test) | Limbal Redness | Grade 2 = Mild redness | 26 eyes |
Secondary
Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire.
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A Lens (Control) | Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | 80.32 CLUE score | Standard Deviation 18.36 |
| Galyfilcon A Lens (Test) | Subjective Assessment of Lens Comfort Using the Contact Lens User Experience (CLUE)TM Questionnaire. | 82.76 CLUE score | Standard Deviation 17.01 |