Clinical Comparison of Two Daily Disposable Contact Lenses in a Population of Daily Disposable Contact Lens Wearers

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233076
• Other study ID #: P-337-C-034
• Status: Completed
• Phase: N/A
• First received: November 1, 2010
• Last updated: June 26, 2012
• Start date: October 2010
• Est. completion date: November 2010

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the performance of two commercially marketed daily disposable contact lenses in a population of daily disposable contact lens wearers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Currently wearing daily disposable lenses in daily wear, daily disposable modality, except DAILIES AquaComfort Plus and 1-DAY ACUVUE TruEye.

• Able to wear study lenses in the available powers from -1.00D to -6.00D.

• Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

• Eye injury within twelve weeks of enrollment.

• History of corneal or refractive surgery.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Currently enrolled in any clinical trial.

• Currently wearing DAILIES AquaComfort Plus or 1-DAY ACUVUE TruEye lenses.

• Monovision correction during the study.

• Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Nelfilcon A contact lens
Commercially marketed, spherical contact lens for daily wear, daily disposable use
• Narafilcon B contact lens
Commercially marketed (US), spherical contact lens for daily wear, daily disposable use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CIBA VISION

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Vision Quality	Overall vision quality, as interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 1 week of wear. Overall vision quality is evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent.	1 week of wear	No