Astigmatism
Conditions
Brief summary
This study was to evaluate the patient subjective experiences of two daily disposable toric contact lenses.
Detailed description
This was a participant masked, interventional, prospective, direct refit, bilateral wear study. The purpose of this study was to evaluate the patient subjective experiences of a hydrogel daily disposable toric contact lens when compared to a silicone hydrogel daily disposable toric contact lens after 15 minutes of daily wear each.
Interventions
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
A person was eligible for inclusion in the study if he/she: * Is at least 18 years of age and has full legal capacity to volunteer. * Has read and signed an information consent letter. * Self-reports having a full eye examination in the previous two years. * Anticipates being able to wear the study lenses for at least 8 hours a day, 5 days a week. * Is willing and able to follow instructions and maintain the appointment schedule. * Habitual soft contact lens wearers who currently wear toric contact lenses, or use spectacles for all distances vision correction, for the past 3 months minimum. * Has a contact lens spherical prescription between plano to - 10.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye. * Has refractive astigmatism no less than -0.75D and no more than 1.75D in both eyes. * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. * Has clear corneas and no active ocular disease. * Has read, understood, and signed the information consent letter.
Exclusion criteria
A person was excluded from the study if he/she: 1. Is participating in any concurrent clinical or research study. 2. Has any known active ocular disease and/or infection that contraindicates contact lens wear. 3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable. 4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable. 5. Has known sensitivity to the diagnostic sodium fluorescein used in the study. 6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment. 7. Has undergone refractive error surgery or intraocular surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Handling at Insertion, Dispensing Visit | 15 minutes | Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear. |
| Subjecting Handling at Insertion, Follow-up Visit | 15 minutes | Subjective handling at lens insertion was assessed at the follow-up visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes study participants that completed all study visits | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous Female | 27.08 years STANDARD_DEVIATION 6.17 | — |
| Age, Continuous Male | 27.10 years STANDARD_DEVIATION 6.04 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 27 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Subjecting Handling at Insertion, Follow-up Visit
Subjective handling at lens insertion was assessed at the follow-up visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Subjecting Handling at Insertion, Follow-up Visit | 92.63 score on a scale | Standard Deviation 9.28 |
| Lens B | Subjecting Handling at Insertion, Follow-up Visit | 90.13 score on a scale | Standard Deviation 9.97 |
Primary
Subjective Handling at Insertion, Dispensing Visit
Subjective handling an lens insertion was assessed at the dispending visit using a 0-100 scale, where 100=Excellent, very easy; 0=Very difficult to manage. Collected once at the end of 15 minutes of wear.
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A | Subjective Handling at Insertion, Dispensing Visit | 87.13 score on a scale | Standard Deviation 13.68 |
| Lens B | Subjective Handling at Insertion, Dispensing Visit | 88.50 score on a scale | Standard Deviation 10.14 |