NCT02484586

Dispensing Study to Assess the Visual Performance of Optimised Prototype Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Brien Holden Vision · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to assess the visual performance of multiple optimised prototype soft contact lens designs compared to commercially available contact lenses.

Detailed description

Prospective, double-masked, crossover, bilateral wear, dispensing clinical trial where participants will wear multiple prototype (test) and commercial (control) lenses. Multiple prototype contact lens designs will be assessed against commercial control lenses during the study, where each design will be worn for up to a week. There will be a minimum 1 night washout period between lens designs.

Conditions

• Presbyopia
• Refractive Error

Interventions

Type	Name	Description
DEVICE	Etafilcon A	Prototype lens material
DEVICE	Etafilcon A	Control lens for presbyope group
DEVICE	Nelfilcon A	Control lens for presbyope group
DEVICE	Nesofilcon A	Control lens for presbyope group
DEVICE	Nelfilcon A	Control lens for non-presbyope group
DEVICE	Etafilcon A	Control lens for non-presbyope group
DEVICE	Somofilcon A	Control lens for presbyope group
DEVICE	58% Poly-HEMA	Control lens for presbyope group
DEVICE	Omafilcon A	Control lens for non-presbyope group

Timeline

• Start date: 2015-10-01
• Primary completion: 2017-02-07
• Completion: 2017-02-07
• First posted: 2015-06-29
• Last updated: 2017-09-11

Locations

1 site across 1 country: Australia