Refractive Error
Conditions
Brief summary
The objective of this study is to compare the ease of removing two daily disposable soft contact lenses off the eye.
Interventions
DEVICEdelefilcon A
Daily disposable soft contact lens to be worn at least 8 hours daily
DEVICEnarafilcon A
Daily disposable contact lens to be worn at least 8 hours daily
Sponsors
Johnson & Johnson Vision Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject must be between 18 and 45 years of age (inclusive)with no presbyopic add. 2. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form. This should be recorded on the Case Report Form (CRF). 3. The subject must be willing to wear the study lenses for at least 8 hours per day, at least 6 days between visits. 4. The subject must be a current successful spherical soft contact lens wearer in both eyes. 5. The subject must appear willing and able to adhere to the instructions set forth in this clinical protocol. 6. The subject's subjective refraction must result in a vertex corrected spherical contact lens prescription in the range of -1.00D to -6.00D (inclusive) in each eye. 7. The subject's refractive astigmatism must be less than or equal to -0.75D in both eyes. 8. The subject must have corrective visual acuity of 6/9 (20/30) or better in each eye. 9. The subject must require a visual correction in both eyes (no monofit or monovision allowed).
Exclusion criteria
1. Any ocular or systemic allergies or diseases that may interfere with contact lens wear. 2. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 3. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or infiltrates 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. Currently pregnant or lactating (subject who become pregnant during the study will be discontinued). 8. Diabetes. 9. Infectious diseases (e.g. hepatitis, tuberculosis) or an immunosuppressive disease (e.g. HIV). 10. Amblyopia 11. Evidence of lid abnormality or infection (including blepharitis/meibomitis) 12. Conjunctival abnormality or infection. 13. Any active ocular disease. 14. Employee or family member of the staff of the investigational site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Ease of Lens Removal | Day 7 | After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor). |
Countries
United Kingdom
Participant flow
Pre-assignment details
A total of 279 subjects were enrolled in the study; 4 did not meet the eligibility criteria, 2 prematurely discontinued and 273 completed the study. Of those 273 completers, 23 were excluded from the primary analysis due to major protocol deviations; hence, 250 completed the study per protocol and were included in the analysis.
Participants by arm
| Arm | Count |
|---|---|
| Delefilcon A Spherical daily disposable soft contact lens
delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily | 137 |
| Narafilcon A Spherical daily disposable soft contact lens Class 1 UV blocking
narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily | 138 |
| Total | 275 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Unsatisfactory Lens Fitting | 1 | 0 |
Baseline characteristics
| Characteristic | Delefilcon A | Narafilcon A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 11 Participants | 9 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 126 Participants | 129 Participants | 255 Participants |
| Age, Continuous | 30.0 years STANDARD_DEVIATION 8.17 | 29.0 years STANDARD_DEVIATION 7.69 | 29.5 years STANDARD_DEVIATION 7.93 |
| Region of Enrollment United Kingdom | 88 participants | 87 participants | 175 participants |
| Region of Enrollment United States | 49 participants | 51 participants | 100 participants |
| Sex: Female, Male Female | 99 Participants | 76 Participants | 175 Participants |
| Sex: Female, Male Male | 38 Participants | 62 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 137 | 0 / 138 |
| serious Total, serious adverse events | 0 / 137 | 0 / 138 |
Outcome results
Primary
Subjective Ease of Lens Removal
After 1-week of lens wear, each subject was asked to rate a question, 'Ease of taking the lenses off of your eyes', using 5-point scale (1=Excellent, 2=Very Good, 3=Good, 4=Fair, 5=Poor).
Time frame: Day 7
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Delefilcon A | Subjective Ease of Lens Removal | Very Good | 23 participants |
| Delefilcon A | Subjective Ease of Lens Removal | Fair | 23 participants |
| Delefilcon A | Subjective Ease of Lens Removal | Good | 24 participants |
| Delefilcon A | Subjective Ease of Lens Removal | Poor | 12 participants |
| Delefilcon A | Subjective Ease of Lens Removal | Excellent | 45 participants |
| Narafilcon A | Subjective Ease of Lens Removal | Poor | 0 participants |
| Narafilcon A | Subjective Ease of Lens Removal | Excellent | 76 participants |
| Narafilcon A | Subjective Ease of Lens Removal | Very Good | 34 participants |
| Narafilcon A | Subjective Ease of Lens Removal | Good | 10 participants |
| Narafilcon A | Subjective Ease of Lens Removal | Fair | 3 participants |