In-vivo Wettability Grading and Assessment Study

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: enfilcon A; Device: lotrafilcon B; Device: balafilcon A; Device: senofilcon A

• Registration Number: NCT01010555
• Lead Sponsor: CIBA VISION

Brief Summary

The purpose of this study is to investigate the front surface wettability of soft contact lenses while on eye.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-05-03
• Results First Submitted QC: 2011-05-03
• Results First Posted: 2011-05-30
• Status Verified: 2012-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• is at least 17 years of age
• has read and signed an information consent letter
• is a current daily wear contact lens wearer
• has acceptable fit with the study lenses
• has had an ocular exam in the last two years
• other protocol-defined inclusion criteria may apply

Exclusion Criteria

• has any ocular disease
• has undergone corneal refractive surgery or is aphakic
• has any systemic disease affecting ocular health
• is pregnant or lactating
• other protocol-defined exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
enfilcon A	enfilcon A	Enfilcon A contact lens randomly assigned to one eye, with senofilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
lotrafilcon B	lotrafilcon B	Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
balafilcon A	balafilcon A	Balafilcon A contact lens randomly assigned to one eye, with lotrafilcon B contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear senofilcon A contact lens randomly assigned to one eye and enfilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.
senofilcon A	senofilcon A	Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral wear. Both products to be worn on a daily wear basis for 4 weeks, after which participant will wear lotrafilcon B contact lens randomly assigned to one eye and balafilcon A contact lens in the fellow eye for an additional 4 weeks of daily wear.

Primary Outcome Measures

Name	Time	Method
On-eye Wettability	4 weeks of wear	On-eye wettability, as assessed at the 4-week visit by a masked observer from a video taken of the eye 5 minutes after lens insertion. On-eye wettability was recorded on a 5-point scale, with 0=excellent and 4=very poor.

Trial Locations

Locations (1)

Centre for Contact Lens Research: University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada