In-vivo Wettability Grading and Assessment Study

Myopia Clinical Trial

— CIAN  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010555
• Other study ID #: P-368-C-104
• Status: Completed
• Phase: N/A
• First received: November 9, 2009
• Last updated: June 26, 2012
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• lotrafilcon B
Commercially marketed, silicone hydrogel, spherical contact lens
• balafilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
• senofilcon A
Commercially marketed, silicone hydrogel, spherical contact lens
• enfilcon A
Commercially marketed, silicone hydrogel, spherical contact lens

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research: University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
CIBA VISION	University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	On-eye Wettability	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.	4 weeks of wear	No