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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Visco soft contact lens | Experimental | Olifilcon A, Daily wear, monthly disposable soft contact lens |
|
| Biofinity soft contact lens | Active Comparator | Comfilcon A, Daily wear, monthly disposable soft contact lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofinity soft contact lens | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | Visual acuity correctable to snellen 20/25 or better | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Slit Lamp Findings | Any slit lamp finding > Grade 2; Measured on a scale of 0-4 with 0=no findings and 4=severe findings | 3 month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huey Chuan Cheng, MD. MS | Mackey Memorial Hospital | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity | Visual acuity correctable to snellen 20/25 or better | Posted | Count of Units | eye | 3 months | eye | eye |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Visco Soft Contact Lens | Olifilcon A, Daily wear, monthly disposable soft contact lens Visco 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Huey-Chuan Cheng | Mackay Memorial Hospital_Taipei | 886-2-25433535 | hccheng@ms2.mmh.org.tw |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Visco soft contact lens | Device | 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. |
|
| 3 month |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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 | Posted | Count of Units | eye | 3 month | eye | 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 | Posted | Count of Units | eye | 3 month | eye | eye |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Biofinity Soft Contact Lens | Comfilcon A, Daily wear, monthly disposable soft contact lens Biofinity 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. | 0 | 20 | 0 | 20 | 0 | 20 |
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