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 this study is to evaluate the short-term clinical performance of two toric contact lenses when compared to each other after 15 minutes of daily wear each.
Interventions
DEVICELens A (ocufilcon D)
15 minutes of daily wear
DEVICELens B (fanfilcon A)
15 minutes of daily wear
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
* Is between 18 and 40 years of age (inclusive) * Has had a self-reported visual exam in the last two years. * Is an adapted soft contact lens wearer. * Is not a habitual wearer of either study lens. * Has a contact lens spherical prescription between +5.00 to -9.00 (inclusive) best corrected visual acuity of 20/30 or better in either eye. * Have contact lens prescription of no less than -0.75D of astigmatism and no more than -2.25D 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 informed consent letter. * Patient contact lens refraction should fit within the available parameters of the study lenses. * Is willing to comply with the wear schedule (at least 5 days per week, \>8 hours/day assuming there are no contraindications for doing so). * Is willing to comply with the visit schedule.
Exclusion criteria
* Has a CL prescription outside the range of the available parameters of the study lenses. * Has a spectacle cylinder less than -0.75D or more than -2.50D of cylinder in either eye. * Slit lamp findings that would contraindicate contact lens wear such as: 1. Pathological dry eye or associated findings 2. Pterygium, pinguecula, or corneal scars within the visual axis 3. Neovascularization \> 0.75 mm in form of the limbus 4. Giant papillary conjuctivitis (GCP) worse than grade 1 5. Anterior uveitis or iritis (past or present) 6. Seborrheic eczema, seborrheic conjunctivitis 7. History of corneal ulcers or fungal infections 8. Poor personal hygiene 9. Has a known history of corneal hypoesthesia (reduced corneal sensitivity) 10. Has aphakia, keratoconus or a highly irregular cornea. 11. Has Presbyopia or has dependence on spectacles for near work over the contact lenses. 12. Has undergone corneal refractive surgery. 13. Is participating in any other type of eye related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Fit Acceptance | At the end of 15 minutes of daily wear | Overall lens fit acceptance was measured on a scale from 0-4 (0= Should not be worn, 4= Perfect) |
Countries
Mexico
Participant flow
Pre-assignment details
Forty participants were screened. All the participants who were eligible in the study were included in the analysis. (n=40)
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Includes all Study Participants | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | All Study Participants | — |
|---|---|---|
| Age, Continuous | 25.6 years STANDARD_DEVIATION 7.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 28 Participants | — |
| Sex: Female, Male Male | 12 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
Overall Fit Acceptance
Overall lens fit acceptance was measured on a scale from 0-4 (0= Should not be worn, 4= Perfect)
Time frame: At the end of 15 minutes of daily wear
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lens A (Ocufilcon D) | Overall Fit Acceptance | 3.6 units on a scale | Standard Deviation 0.8 |
| Lens B (Fanfilcon A) | Overall Fit Acceptance | 3.7 units on a scale | Standard Deviation 0.6 |