Myopia, Hyperopia, Astigmatism
Conditions
Brief summary
Bilateral dispensing clinical trial of fanfilcon A toric lens verses enfilcon A toric lens over two weeks.
Detailed description
Evaluation of the clinical performance of an investigational silicone-hydrogel lens called fanfilcon A (test) compared to a FDA-cleared commercially available contact lens called enfilcon A toric lens (control) when worn on a daily wear basis over 2 weeks in a randomized, bilateral, cross-over, dispensing study.
Interventions
DEVICEfanfilcon A
contact lens
DEVICEenfilcon A
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are at least 17 years of age for Canada and 18 years of age for the USA and have full legal capacity to volunteer; * Have read and signed an information consent letter; * Are willing and able to follow instructions and maintain the appointment schedule; * Are an adapted soft contact lens wearer; * Require spectacle lens powers in both eyes; * Sphere: between -0.50 to -6.00 diopters and * Astigmatism: between -1.25 to -2.00 and * Axis: 180 ± 20 degrees * Are willing to wear contact lens in both eyes; * Have manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye; * To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit including toric orientation as acceptable;
Exclusion criteria
* Are participating in any concurrent clinical or research study; * Have any known active\* ocular disease and/or infection; * Have a systemic condition that in the opinion of the investigator may affect a study outcome variable; * Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; * Have known sensitivity to the diagnostic pharmaceuticals to be used in the study; * Are pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); * Are aphakic; * Have undergone refractive error surgery;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comfort (Subjective Rating Scale) | Dispensing (Baseline) and 2 weeks | Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever) |
| Comfort Preference | Dispensing (Baseline) and 2 weeks | Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference. |
Countries
Canada, United States
Participant flow
Pre-assignment details
44 subjects were enrolled (assigned an ID per protocol), but 11 were not assigned to any group due to screen failure.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All subjects were wore both fanfilcon A and enfilcon A toric lenses as either the first or second intervention. | 44 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Lens 1 | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 24 years STANDARD_DEVIATION 5 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 32 |
| other Total, other adverse events | 0 / 33 | 0 / 32 |
| serious Total, serious adverse events | 0 / 33 | 0 / 32 |
Outcome results
Primary
Comfort Preference
Subjective assessment for comfort preference for each lens pair. Choices: fanfilcon A lens, enfilcon A lens, No preference.
Time frame: Dispensing (Baseline) and 2 weeks
Population: Analysis population differs slightly due to protocol deviation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Fanfilcon A | Comfort Preference | fanfilcon A | 12 Participants |
| Fanfilcon A | Comfort Preference | enfilcon A | 10 Participants |
| Fanfilcon A | Comfort Preference | No Preference | 9 Participants |
| Enfilcon A | Comfort Preference | fanfilcon A | 14 Participants |
| Enfilcon A | Comfort Preference | enfilcon A | 12 Participants |
| Enfilcon A | Comfort Preference | No Preference | 5 Participants |
Primary
Comfort (Subjective Rating Scale)
Participant rating for comfort at dispense visit and at the 2 week follow-up on a subjective rating scale (0-100, 0=cannot be worn. Causes pain,100=Cannot be felt ever)
Time frame: Dispensing (Baseline) and 2 weeks
Population: Analysis population differs slightly due to 1 participant who was excluded from analysis due to a protocol deviation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fanfilcon A | Comfort (Subjective Rating Scale) | Dispensing | 87 units on a scale | Standard Deviation 17 |
| Fanfilcon A | Comfort (Subjective Rating Scale) | 2 week | 79 units on a scale | Standard Deviation 15 |
| Enfilcon A | Comfort (Subjective Rating Scale) | Dispensing | 88 units on a scale | Standard Deviation 10 |
| Enfilcon A | Comfort (Subjective Rating Scale) | 2 week | 76 units on a scale | Standard Deviation 18 |