Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses

Myopia Clinical Trial

— QUINCE  

Official title:

Ophthalmic Compatibility During Seven Days of Continuous Wear of Silicone Hydrogel Lenses (P/318/08/C)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934102
• Other study ID #: P-368-C-103
• Status: Completed
• Phase: N/A
• First received: July 6, 2009
• Last updated: June 26, 2012
• Start date: August 2009
• Est. completion date: September 2009

Study information

• Verified date: November 2010
• 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 assess the ophthalmic compatibility of three different silicone hydrogel lenses worn on an overnight basis for six nights.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

• Is at least 17 years of age and has full legal capacity to volunteer

• Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual vision correction

• Has had an ocular examination in the last two years

• Is a current soft (hydrogel or silicone hydrogel) contact lens wearer

• Has clear corneas and no active ocular disease

• Can be successfully fit with the lenses to be used in the study

• Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

• Is pregnant or lactating

• Has undergone corneal refractive surgery

• Currently wears lenses on an extended wear basis or was on extended wear within six months prior to the study

• Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Narafilcon A contact lens
Investigational, silicone hydrogel, spherical soft contact lens
• Lotrafilcon A contact lens
Commercially marketed, silicone hydrogel, spherical soft contact lens
• Galyfilcon A contact lens
Commercially marketed, silicone hydrogel, spherical soft 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	Front Surface Lens Deposits	Protein and lipid deposits on the contact lens surface as assessed by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4 with 0 being none and 4 being severe.	Period 2, Day 6	No