Astigmatism
Conditions
Brief summary
The aim of this study is to compare the short-term clinical performance of two Toric contact lenses.
Detailed description
The aim of the study is to evaluate and compare the performance of two soft toric contact lenses in existing soft toric lens wearers in a short term (15 minutes wear) study.
Interventions
DEVICELens A (omafilcon B)
15 minutes of daily wear.
DEVICELens B (comfilcon A)
15 minutes of daily wear.
Sponsors
Centre for Ocular Research & Education, Canada
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Single
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Are at least 17 years of age and has full legal capacity to volunteer. 2. Have understood and signed an information consent letter. 3. Are willing and able to follow instructions and maintain the appointment schedule. 4. Are an adapted soft toric contact lens wearer. 5. Do not habitually wear either of the two study lens types. 6. Have a vertex-corrected contact lens prescription with a spherical component of +4.00D to -9.00D in combination with astigmatism of no less than -0.75D and no more than -2.25D in each eye. 7. Can achieve best corrected distance visual acuity of +0.10 logMAR (subjective refraction) or better in each eye. 8. Can be fitted with and achieve a distance visual acuity of +0.18 logMAR or better in each eye with the study contact lenses.
Exclusion criteria
1. Are participating in any concurrent clinical or research study. 2. Have any known active ocular disease and/or infection or slit lamp findings that would contraindicate contact lens use. 3. Have a systemic condition that in the opinion of the investigator may affect a study outcome variable. 4. Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable. 5. Have known sensitivity to the diagnostic pharmaceuticals to be used in the study. 6. Have a history of not achieving comfortable CL use (5 days per week; \> 8 hours/day) 7. Are an employee of the Centre for Ocular Research & Education directly involved in the study (i.e. on the delegation log).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Fit Acceptance | After 15 minutes of continuous wear | Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect) |
Countries
Canada
Participant flow
Pre-assignment details
Thirty-eight Participants were screened. One Participant was not eligible due to screening failure. All the participants who were eligible in the study were included in the analysis. (n=37)
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes all Study Participants | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 29.6 years STANDARD_DEVIATION 13 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 32 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 |
| other Total, other adverse events | 0 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
Overall Fit Acceptance
Overall fit acceptance will be measured on scale of (0-4) where (0=Should not be worn and 4=Perfect)
Time frame: After 15 minutes of continuous wear
Population: All the participants who were eligible in the study were included in the analysis. (n=37)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A (Omafilcon B) | Overall Fit Acceptance | 3.5 Units on Scale | Standard Deviation 0.7 |
| Lens B (Comfilcon A) | Overall Fit Acceptance | 3.8 Units on Scale | Standard Deviation 0.4 |