Myopia
Conditions
Brief summary
The purpose of this study is to evaluate the lens fit (mechanical and cosmetic lens fit) of the printed etafilcon A with polyvinylpyrrolidone (PVP).
Interventions
DEVICEetafilcon A (A)
Daily wear contact lens
DEVICEetafilcon A (B)
Daily wear contact lens
DEVICEetafilcon A (C)
Daily wear contact lens
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. The subject must be at least 18 years of age and less than 40 years of age. 2. The subject must be a light eye Caucasian female habitual soft contact lens wearer. 3. The subject must be concept acceptors for cosmetic and/or limbal ring lenses. A concept screening questionnaire will be used and top 3 box (in 5-point scale) is eligible. 4. The subject must have no known ocular or systemic allergies that might interfere with contact lens wear. 5. The subject must have no known systemic disease, or need for medication, which might interfere with contact lens wear. 6. The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D. 7. Any cylinder power must be ≤ -0.75D. 8. The subject must have visual acuity best correctable to 20/25+3 or better for each eye. 9. The subject must have normal eyes (no ocular medications or ocular infection of any type). 10. The subject must read and sign the Statement of Informed Consent. 11. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion criteria
1. Ocular or systemic allergies or disease which might interfere with contact lens wear. 2. Systemic disease or use of medication which might interfere with contact lens wear. 3. Clinically significant (grade 3 or worse) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear. 4. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear. 5. Any ocular infection. 6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 7. Any color deficiencies - to the best of the subject's knowledge. 8. Pregnancy or lactation. 9. Diabetes. 10. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV). 11. Habitual contact lens type is toric, multifocal, or is worn as extended wear.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit Acceptance | 10-15 minutes post lens fit | Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular Snellen Visual Acuity (VA) | 10-15 minutes post lens fit | Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction. |
| Corneal Staining | After 6-9 days of lens wear | Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis. |
Countries
United States
Participant flow
Recruitment details
This study was an eight-site, randomized, 4-visit, bilateral crossover, dispensing trial.
Pre-assignment details
Of those 95 enrolled subjects in this study, 3 did not meet the eligibility criteria, 6 prematurely discontinued from the study, and 6 excluded from the analysis due to protocol deviations.
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Subjects were to wear all three lenses over the course of the study. | 95 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Poor lens fit | 4 |
| Overall Study | Protocol Violation | 6 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 95 Participants |
| Region of Enrollment United States | 95 participants |
| Sex: Female, Male Female | 95 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 95 |
| serious Total, serious adverse events | 1 / 95 |
Outcome results
Primary
Lens Fit Acceptance
Lens fit acceptance (whether acceptable or unacceptable) was assessed by the Investigator at dispensing.
Time frame: 10-15 minutes post lens fit
Population: All subjects who successfully completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A (A) | Lens Fit Acceptance | Acceptable | 158 eyes |
| Etafilcon A (A) | Lens Fit Acceptance | Unacceptable | 0 eyes |
| Etafilcon A (B) | Lens Fit Acceptance | Acceptable | 158 eyes |
| Etafilcon A (B) | Lens Fit Acceptance | Unacceptable | 2 eyes |
| Etafilcon A (C) | Lens Fit Acceptance | Acceptable | 157 eyes |
| Etafilcon A (C) | Lens Fit Acceptance | Unacceptable | 0 eyes |
Secondary
Binocular Snellen Visual Acuity (VA)
Binocular Snellen VA was assessed at dispensing by Investigator using a Snellen vision chart. Subjects were analyzed based on their performance on a Snellen Vision chart exam in the study lenses in an effort to measure how well the lenses perform for vision correction.
Time frame: 10-15 minutes post lens fit
Population: All subjects who successfully completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A (A) | Binocular Snellen Visual Acuity (VA) | 20/15 | 42 participants |
| Etafilcon A (A) | Binocular Snellen Visual Acuity (VA) | 20/20 | 36 participants |
| Etafilcon A (B) | Binocular Snellen Visual Acuity (VA) | 20/15 | 39 participants |
| Etafilcon A (B) | Binocular Snellen Visual Acuity (VA) | 20/20 | 39 participants |
| Etafilcon A (C) | Binocular Snellen Visual Acuity (VA) | 20/15 | 45 participants |
| Etafilcon A (C) | Binocular Snellen Visual Acuity (VA) | 20/20 | 33 participants |
Secondary
Corneal Staining
Corneal staining type was graded in a 5-point scale over the 5 corneal regions by Investigator using a slit lamp; 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe. Maximum grade of corneal staining type over the 5 corneal regions was categorized either absence or presence of corneal staining for the analysis.
Time frame: After 6-9 days of lens wear
Population: All subjects who successfully completed the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etafilcon A (A) | Corneal Staining | Central region grade > 0 | 4 eyes |
| Etafilcon A (A) | Corneal Staining | Superior region grade > 0 | 7 eyes |
| Etafilcon A (A) | Corneal Staining | Nasal region grade > 0 | 2 eyes |
| Etafilcon A (A) | Corneal Staining | Temporal region grade > 0 | 8 eyes |
| Etafilcon A (A) | Corneal Staining | Inferior region grade > 0 | 34 eyes |
| Etafilcon A (B) | Corneal Staining | Temporal region grade > 0 | 3 eyes |
| Etafilcon A (B) | Corneal Staining | Central region grade > 0 | 6 eyes |
| Etafilcon A (B) | Corneal Staining | Inferior region grade > 0 | 25 eyes |
| Etafilcon A (B) | Corneal Staining | Nasal region grade > 0 | 6 eyes |
| Etafilcon A (B) | Corneal Staining | Superior region grade > 0 | 5 eyes |
| Etafilcon A (C) | Corneal Staining | Inferior region grade > 0 | 44 eyes |
| Etafilcon A (C) | Corneal Staining | Temporal region grade > 0 | 5 eyes |
| Etafilcon A (C) | Corneal Staining | Superior region grade > 0 | 3 eyes |
| Etafilcon A (C) | Corneal Staining | Central region grade > 0 | 3 eyes |
| Etafilcon A (C) | Corneal Staining | Nasal region grade > 0 | 7 eyes |