NCT02214797

Dispensing Study to Assess Visual Performance of Prototype Contact Lenses

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 67 (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 visual performance of prototype soft contact lens designs compared to commercially available contact lenses over one-week of lens wear.

Detailed description

Prospective, participant-masked, multiple arm, crossover dispensing clinical trial where participants will wear prototype (test) and commercial (control) lenses bilaterally. Participants will be stratified based on their refractive error into either presbyopic or non-presbyopic group. Each of the stratified group will have a maximum of 4 parallel arms. Up to 4 test lens designs will be assessed against the control/s in each parallel arm in a randomized cross over fashion, with a minimum 2 day washout period between the lens types. Each lens assessment will require 2 scheduled clinic attendances - a fitting visit and an evaluation visit.

Conditions

• Presbyopia
• Refractive Error

Interventions

Type	Name	Description
DEVICE	Etafilcon A, Lotrafilcon B , Senofilcon A

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-08-12
• Last updated: 2015-06-25

Locations

1 site across 1 country: Australia