NCT03139201

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

A Prospective Randomized Controlled Study to Evaluate the Clinical Performance of OxyAqua 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 OxyAqua 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 from one hospital. 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	OxyAqua	OxyAqua (olifilcon D) silicone hydrogel soft contact lens
DEVICE	Si-Hy	Si-Hy (oliflcon B) silicone hydrogel soft contact lens

Timeline

• Start date: 2016-09-21
• Primary completion: 2016-12-08
• Completion: 2016-12-08
• First posted: 2017-05-03
• Last updated: 2017-05-03