NCT04886479

Comparing Silicone Hydrogel Contact Lens Wearers to Hydrogel Contact Lens Wearers and Non-lens Wearers

Comparing Habitual Daily Disposable Silicone Hydrogel (DDSH) Contact Lens Wearers to Habitual Daily Disposable Hydrogel (DDH) Contact Lens Wearers and Non-lens Wearers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 17 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study was a multi-site, prospective, randomized, non-masked, unilateral, non-dispensing study.

Detailed description

The purpose of this study was to to compare physiological response baseline data between 3 groups - habitual wearers of Daily Disposable Silicone Hydrogel (DDSH) contact lenses, habitual wearers of Daily Disposable Hydrogel (DDH) contact lenses, and non-lens wearers. The study then compared physiological response data following wear of a low Dk HEMA contact lens between habitual wearers of DDSH and habitual wearers of DDH.

Conditions

• Myopia

Interventions

Type	Name	Description
OTHER	Control	No lens
DEVICE	Test Lens	Low Dk HEMA contact lens worn for 3 hours

Timeline

• Start date: 2019-03-06
• Primary completion: 2022-10-07
• Completion: 2022-10-07
• First posted: 2021-05-14
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

2 sites across 2 countries: Canada, United Kingdom

Regulatory

• FDA-regulated device study