N/A
N=60
Clinical Evaluation of Two Daily Wear Silicon Hydrogel Contact Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT02354924 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Visual Acuity — 80; 40 eye
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biofinity soft contact lens (Device); Visco soft contact lens (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Visco Vision Inc.
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
80; 40 | — |
| SECONDARY Slit Lamp Findings |
0; 0 | — |
| SECONDARY Symptoms, Problems and Complaints and Incidence Rate |
0; 0 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02354924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.