NCT02362724

Evaluation of Investigational (Frequent Replacement) FRP Lens for Daily Wear

Evaluation of the CooperVision, Inc. Sapphire and Pearl Silicone Hydrogel Daily Wear Contact Lenses When Used for Frequent Replacement for Up to One (1) Month of Daily Wear.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the investigational contact lens to a marketed contact lens. The study results were not used for design validation of investigational contact lens,

Detailed description

The objective of this evaluation is to provide evidence supporting the claim that the performance of the Test Lens is substantially equivalent to that of the Control Lens when used in a one month (up to 30 days) recommended replacement, daily wear modality. The study results were not used for design validation of investigational contact lens,

Conditions

• Ametropia

Interventions

Type	Name	Description
DEVICE	Sapphire	silicone hydrogel contact lens
DEVICE	Pearl	silicone hydrogel contact lens

Timeline

• Start date: 2015-02-01
• Primary completion: 2015-06-01
• Completion: 2015-12-01
• First posted: 2015-02-13
• Last updated: 2020-10-14
• Results posted: 2020-09-24

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study