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This was a prospective, randomized, double-blind, parallel, active-controlled clinical study to assess the safety and efficacy of Silicone Hydrogel Contact Lens for vision correction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | Si-Hy (Samfilcon A) |
|
| Group II | Experimental | Si-Hy (Otufilcon A) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Soft Contact Lens | Device | Vision Correction |
|
| Measure | Description | Time Frame |
|---|---|---|
| The effectiveness of corrected visual acuity | The effectiveness of corrected visual acuity at 3-month. Effectiveness is defined as visual acuities of both eyes correctable to ≥1.0 with contact lens. Effectiveness formula (%): total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %. Definition of total number of subjects enrolled at a given time: the total number of subjects conforming to the PPS criteria and having worn lenses for 3 months. | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of corrected visual acuity | Effectiveness of corrected visual acuity at 1 week, 1 month and 2 months. The effectiveness (%) is defined as total number of subjects with vision correction of ≥ 1.0 at a given timepoint / total number of subjects enrolled at a given time × 100 %. | 1 week, 1 month and 2 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tri-Service General Hospital | Taipei | 114202 | Taiwan | |||
| Linkou Chang Gung Memorial Hospital |
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| Average contact lens corrected visual acuity |
The mean, standard deviation, median, maximum, minimum, Q1, Q3 and Inter-Quartile Range (IQR) will be calculated for "Lens corrected visual acuity". Comparisons between the Treatment group and Control group will be made. |
| 1 week, 1 month, 2 months and 3 months |
| Change in diopter (Spherical and cylindrical power of subjective optometry) | The mean, standard deviation, median, maximum, minimum, Q1, Q3 and Inter-Quartile Range (IQR) will be calculated for "power" (the spherical and cylindrical power). Comparisons between the Treatment group and Control group will be made. | 1 week, 1 month, 2 months and 3 months |
| Change in corneal astigmatism (the vertical and horizontal keratometry meridian, the power and axis of astigmatism) | The mean, standard deviation, median, maximum, minimum, Q1, Q3, and Inter-Quartile Range (IQR) will be calculated for "corneal astigmatism" (the vertical and horizontal curvature, the power and axis of astigmatism). Comparisons between the Treatment group and Control group will be made. | 1 week, 1 month, 2 months and 3 months |
| Lens broken rate | The number and percentage of parameters (total lenses, unbroken lenses, broken lenses) will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made. | 1 week, 1 month, 2 months and 3 months |
| Lens fitting (lens centration, lens movement, coverage, and tightness) | The total number and percentage of parameters (lens centration, lens movement, coverage, tightness) with grading scale evaluated by investigators will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made. | 1 week, 1 month, 2 months and 3 months |
| Subjective acceptance (comfort, vision, lens handling, lens cleaning) | The total number and percentage of parameters (comfort, vision, lens handling, lens cleaning) with a grading scale using questionnaires will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made. | 1 week, 1 month, 2 months and 3 months |
| Lens state (lens front surface wettability, front surface deposits, back surface deposits) | The total number and percentage of parameters (lens front surface wettability, front surface deposits, back surface deposits) with a grading scale evaluated by investigators will be calculated and analyzed. Comparisons between the Treatment group and Control group will be made. | 1 week, 1 month, 2 months and 3 months |
| Taoyuan |
| 333 |
| Taiwan |
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| ID | Term |
|---|---|
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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