Myopia
Conditions
Brief summary
The purpose of this study is to demonstrate that the VISCO (Olifilcon A) soft contact lens could be prescribed as a supportive care for myopic persons.
Detailed description
This randomized controlled study will involve at least 50 evaluable subjects divided evenly among 5 study sites in Taiwan. Each study site will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. Subjects who have normal ocular health and conform to a set of standard criteria will wear one of the study lenses on two eyes and follow up for 3 months (90 days). Lenses will be assigned to subject according to a predetermined randomized order. It is necessary to remove contact lenses every day and replace after 30 days. Any unscheduled visit will be allowed when there is a medication necessary. The data for slit lamp findings, symptoms/problems/complaints, keratometry (K) reading, refractive changes (absolute value), visual acuity data, average wear time (AWT), discontinuations, and lens replacement will be collected to claim that the VISCO Soft Contact Lens is as safe and effective as BIOFINITY (comfilcon A) Soft Contact Lens (CooperVision).
Interventions
DEVICEBiofinity soft contact lens
Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
DEVICEVisco soft contact lens
Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
Sponsors
Visco Vision Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject should have normal eyes and use no ocular medications * Subject with -1.00 to -10.00 D myopia, less than -1.25 D astigmatism * VA correctable to 20/25 or better. * Willing to comply with all study procedures and be available for the duration of the study. * Provide signed and dated informed consent form.
Exclusion criteria
* Subjects have history of allergies that would contraindicate solution use and/or normal contact lens wear. * Cornea sensitivity low, high myopes, Keratoconus, dry eye with Schirmer Test \< 5mm/5min or other physical condition that would contraindicate contact lens wear. * Subjects have other active ocular or systemic disease that would contraindicate contact lens wear. * Subjects have medications that would contraindicate contact lens wear. * Females who are pregnant, breastfeeding, birth control pill taken or who intended to become pregnant over the course of the study. * Current drug or alcohol use or dependence that would interfere with adherence to study requirements. * Individuals participating in other clinical studies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 3 months | Visual acuity correctable to snellen 20/25 or better |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Findings | 3 month | Any slit lamp finding \> Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings |
| Symptoms, Problems and Complaints and Incidence Rate | 3 month | Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Visco Soft Contact Lens Olifilcon A, Daily wear, monthly disposable soft contact lens
Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days. | 40 |
| Biofinity Soft Contact Lens Comfilcon A, Daily wear, monthly disposable soft contact lens
Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days. | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Biofinity Soft Contact Lens | Visco Soft Contact Lens | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 40 Participants | 60 Participants |
| Age, Continuous | 36.30 years STANDARD_DEVIATION 5.53 | 34.15 years STANDARD_DEVIATION 6.44 | 34.87 years STANDARD_DEVIATION 6.13 |
| Region of Enrollment Taiwan | 20 Participants | 40 Participants | 60 Participants |
| Sex: Female, Male Female | 17 Participants | 35 Participants | 52 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 20 |
| other Total, other adverse events | 0 / 40 | 0 / 20 |
| serious Total, serious adverse events | 0 / 40 | 0 / 20 |
Outcome results
Primary
Visual Acuity
Visual acuity correctable to snellen 20/25 or better
Time frame: 3 months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Visco Soft Contact Lens | Visual Acuity | 80 eye |
| Biofinity Soft Contact Lens | Visual Acuity | 40 eye |
Secondary
Slit Lamp Findings
Any slit lamp finding \> Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings
Time frame: 3 month
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Visco Soft Contact Lens | Slit Lamp Findings | 0 eye |
| Biofinity Soft Contact Lens | Slit Lamp Findings | 0 eye |
Secondary
Symptoms, Problems and Complaints and Incidence Rate
Subjective Responses to comfort/symptoms/complaints were measured at every visit. 1=Severe Burning to 10=No Burning for each eye
Time frame: 3 month
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Visco Soft Contact Lens | Symptoms, Problems and Complaints and Incidence Rate | 0 eye |
| Biofinity Soft Contact Lens | Symptoms, Problems and Complaints and Incidence Rate | 0 eye |