Myopia
Conditions
Keywords
Refractive Errors, Eye Diseases
Brief summary
The purpose of this study was to compare subjective ratings of lens handling at insertion for a monthly replacement lens versus a daily disposable lens in habitual soft lens wearers.
Detailed description
This was a non-dispensing, randomized, double-masked, crossover study. Participants wore 2 different contact lenses bilaterally over 4 study visits, all conducted on the same day. Estimated duration of involvement for each participant was 4 hours.
Interventions
DEVICEControl Lens
Daily disposable contact lens for 90 minutes
DEVICETest Lens
Monthly replacement contact lens for 90 minutes
Sponsors
Centre for Ocular Research & Education, Canada
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
1. Were 17 to 40 years of age and have full legal capacity to volunteer; 2. Had read and signed an information consent letter; 3. Were willing and able to follow instructions and maintain the appointment schedule; 4. Were habitual daily wearers of spherical single vision soft contact lenses to correct for distance vision in each eye 5. Were correctable to a visual acuity of 20/20 or better (in each eye) with sphero-cylindrical subjective refraction; 6. Had an astigmatism of ≤ 0.75DC in subjective refraction; 7. Could be fit with the study contact lenses with a power between -1.00 and -6.00DS; this translates to best corrected vision sphere refraction that vertexes to a CL power between -1.00 and -6.00 (inclusive) at screening visit. 8. Demonstrated an acceptable fit with the study lenses.
Exclusion criteria
1. Had taken part in another clinical research study within the last 14 days; 2. Were currently habitual wearers of toric, multifocal or monovision lenses. 3. Had worn any rigid contact lenses in the past 6 months 4. Were an extended lens wearer (i.e., sleeping with their lenses) 5. Had a difference of ≥1.5 D in best vision sphere subjective refraction between eyes; 6. Had amblyopia and/or distance strabismus/binocular vision problem; 7. Had any known active ocular disease, allergies and/or infection; 8. Had a systemic condition that in the opinion of the investigator may affect a study outcome variable; 9. Were using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 10. Had a known sensitivity to the diagnostic pharmaceuticals to be used in the study; 11. Had undergone refractive error surgery or intraocular surgery; 12. Were a member of CORE directly involved in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Handling at Insertion | Immediately after lens application | Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All participants who were dispensed lenses and successfully completed the study | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Continuous | 23.8 years STANDARD_DEVIATION 5.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 26 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Lens Handling at Insertion
Participants completed subjective ratings of the ease of application of the study lenses to eye immediately after lens application on a 0-100 integer scale, where 100=very easy and 0=very difficult.
Time frame: Immediately after lens application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Lens | Lens Handling at Insertion | 83 score on a scale | Standard Deviation 16 |
| Test Lens | Lens Handling at Insertion | 93 score on a scale | Standard Deviation 9 |