NCT02518490

A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear. The study results were not used for design validation of test lens.

Detailed description

Subjects were randomized to wear the test lens in one eye and control lens in the other eye. Both test and control lenses were used in a daily wear modality for one month. The study results were not used for design validation of test lens.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Sapphire Lens	Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
DEVICE	enfilcon A	Each subject will be randomized to wear the test lens on one eye and control lens on one eye.

Timeline

• Start date: 2015-08-01
• Primary completion: 2015-09-01
• Completion: 2015-10-01
• First posted: 2015-08-07
• Last updated: 2020-09-22
• Results posted: 2020-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study