NCT02555098

A Bilateral Dispensing Clinical Trial of an Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens

A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Toric for Astigmatism Lens Over 2 Weeks

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: CooperVision, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was conducted to evaluate the clinical performance of an investigational silicone-hydrogel lens against Senofilcon A toric lens. The study results were not used for design validation of the investigational product.

Detailed description

This will be a randomized, bilateral, 2-week cross-over, double-masked, dispensing study comparing the investigational test lens against the Senofilcon A Toric for Astigmatism control lens.

Conditions

• Astigmatism

Interventions

Type	Name	Description
DEVICE	Sapphire contact lenses	Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair
DEVICE	senofilcon A contact lenses	Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-02-01
• Completion: 2016-04-01
• First posted: 2015-09-21
• Last updated: 2020-10-19
• Results posted: 2020-09-23

Locations

1 site across 1 country: United States