NCT03934788

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Visco Vision Inc. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	oxysoft (olifilcon C)	subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.
DEVICE	Si-Hy (olifilcon B)	subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality.

Timeline

• Start date: 2018-09-26
• Primary completion: 2018-11-29
• Completion: 2018-11-29
• First posted: 2019-05-02
• Last updated: 2019-05-02

Locations

3 sites across 1 country: Taiwan