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the Clinical Performance of the Oxysoft Daily Disposable Silicone Hydrogel Soft Contact Lens

Myopia Clinical Trial

Official title:
A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxySoft Silicone Hydrogel Soft Contact Lens

Clinical Trial Summary

The objective of this study is to demonstrate that the OxySoft silicone hydrogel soft contact lens could be prescribed as a supportive care for myopes.

Clinical Trial Description

This is a double blind randomized control study to evaluate a daily disposable contact lens. It is planned to have 30 evaluable subjects at least divided evenly among 3 independent PIs. Each PI will enroll 12 subjects at least. The ration of evaluable test subjects to control subjects will be 2 to 1. The study lens will be dispensed randomly to subjects who have normal ocular health and conform to a set of criteria. It is necessary to wear the lens 8 hours a day and 5 days a week at least and follow up for one month (30 days). Data will be collected at baseline, 1 week, 2 week and 4 week of daily disposable modality including Adverse Reactions, Slit-lamp findings and Symptoms, Problems, and Complaints, vision acuity, keratometry change and reason for discontinuation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03934788
Study type Interventional
Source Visco Vision Inc.
Contact
Status Completed
Phase N/A
Start date September 26, 2018
Completion date November 29, 2018
View Details
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