Astigmatism
Conditions
Brief summary
Prospective study to evaluate the clinical performance of fanfilcon A toric contact lens and senofilcon A toric contact lens after two weeks of wear.
Detailed description
The aim of this prospective study is to evaluate the clinical performance of Avaira Vitality toric and ACUVUE OASYS® for ASTIGMATISM contact lenses after 2-weeks of wear in each pair.
Interventions
DEVICEfanfilcon A toric lens
contact lens
DEVICEsenofilcon A toric lens
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double masked (participant and investigator)
Intervention model description
Prospective, randomized, double masked, bilateral, 2-weeks, crossover study.
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 * Has a contact lens spherical prescription between +6.00 to - 9.00 (inclusive) * Have no less than -0.75D of astigmatism and no more than -2.25 D 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. * 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 -2.50 D of cylinder in either eye. * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. * Presence of clinically significant (grade 2-4) anterior segment abnormalities * Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * Slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Pterygium, pinguecula, or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from of the limbus * Giant papillary conjunctivitis (GCP) worse than grade 1 * Anterior uveitis or iritis (past or present) * Seborrheic eczema, Seborrheic conjunctivitis * History of corneal ulcers or fungal infections * Poor personal hygiene * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has aphakia, keratoconus or a highly irregular cornea. * Has Presbyopia or has dependence on spectacles for near work over the contact lenses. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lens Centration | Baseline | Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable) |
| Corneal Coverage | Baseline | Lens covering the cornea (Yes, No) |
| Post Blink Movement | Baseline | Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wearing Time | 2 weeks | Average daily wearing time (hours/day) |
| Comfortable Wearing Time | 2 weeks | Comfortable daily wearing time (hours/day) |
Countries
Mexico
Participant flow
Recruitment details
45 habitual lens wearers were enrolled. 1 participant was ineligible for the study due to an unacceptable lens fit. 44 participants were dispensed and completed all study visits.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All subjects are randomized to 2-week cross-over study to compare fanfilcon A and senofilcon A. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 44 Participants | — |
| Age, Continuous | 25 years STANDARD_DEVIATION 7.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Mexico | 44 participants | — |
| Sex: Female, Male Female | 30 Participants | — |
| Sex: Female, Male Male | 14 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Corneal Coverage
Lens covering the cornea (Yes, No)
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fanfilcon A | Corneal Coverage | Yes | 44 Participants |
| Fanfilcon A | Corneal Coverage | No | 0 Participants |
| Senofilcon A | Corneal Coverage | No | 0 Participants |
| Senofilcon A | Corneal Coverage | Yes | 44 Participants |
Primary
Corneal Coverage
Lens covering the cornea (Yes, No)
Time frame: 2 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fanfilcon A | Corneal Coverage | Yes | 44 Participants |
| Fanfilcon A | Corneal Coverage | No | 0 Participants |
| Senofilcon A | Corneal Coverage | Yes | 44 Participants |
| Senofilcon A | Corneal Coverage | No | 0 Participants |
Primary
Lens Centration
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Time frame: Baseline
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fanfilcon A | Lens Centration | 44 Participants |
| Senofilcon A | Lens Centration | 44 Participants |
Primary
Lens Centration
Centration of lens on eye (Optimum, Decentration acceptable, Decentration unacceptable)
Time frame: 2 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fanfilcon A | Lens Centration | Optimal Centration | 44 Participants |
| Fanfilcon A | Lens Centration | Decentration Acceptable | 0 Participants |
| Fanfilcon A | Lens Centration | Decentration unacceptable | 0 Participants |
| Senofilcon A | Lens Centration | Optimal Centration | 44 Participants |
| Senofilcon A | Lens Centration | Decentration Acceptable | 0 Participants |
| Senofilcon A | Lens Centration | Decentration unacceptable | 0 Participants |
Primary
Post Blink Movement
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Post Blink Movement | 1.91 units on a scale | Standard Deviation 0.3 |
| Senofilcon A | Post Blink Movement | 1.98 units on a scale | Standard Deviation 0.3 |
Primary
Post Blink Movement
Amount of lens movement after blink (0-5 Likert Scale, 0=Insufficient, 2=Optimal, 4=Excessive movement)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Post Blink Movement | 2.00 units on a scale | Standard Deviation 0 |
| Senofilcon A | Post Blink Movement | 2.02 units on a scale | Standard Deviation 0.3 |
Secondary
Comfortable Wearing Time
Comfortable daily wearing time (hours/day)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Comfortable Wearing Time | 10.0 hours/day | Standard Deviation 3.2 |
| Senofilcon A | Comfortable Wearing Time | 9.0 hours/day | Standard Deviation 3 |
Secondary
Wearing Time
Average daily wearing time (hours/day)
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fanfilcon A | Wearing Time | 12.2 hours/day | Standard Deviation 2.9 |
| Senofilcon A | Wearing Time | 11.6 hours/day | Standard Deviation 3.1 |