Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01254760
• Other study ID #: P-416-C-001 Sub 04
• Status: Completed
• Phase: N/A
• First received: December 3, 2010
• Last updated: June 26, 2012
• Start date: December 2010
• Est. completion date: January 2011

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 trial is to evaluate and compare the clinical performance of two multifocal contact lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years to 68 Years

Eligibility

Inclusion Criteria:

• Age 41 to 68 (inclusive).

• Spectacle add between +0.75 and +2.75D (inclusive).

• Habitual spectacle prescription = 1.00DC (cyl).

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks of enrollment.

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

• Currently enrolled in a clinical trial.

• Prior refractive surgery.

• Other protocol-defined exclusion criteria may apply.

Study Design

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

Related Conditions & MeSH terms

• Myopia
• Presbyopia

Intervention

Device:
• Nelfilcon A multifocal contact lens, investigational
Investigational, soft, multifocal contact lens for daily wear, daily disposable use.
• Nelfilcon A multifocal contact lens, commercial
Commercially marketed, soft, multifocal contact lens FDA-approved 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	End of Day Comfort	End of day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.	5 days of wear, lenses replaced daily	No
Primary	End of Day Dryness	End of day dryness was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.	5 days of wear, lenses replaced daily	No
Primary	Handling at Removal	Handling at removal was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Handling at removal was measured on a 10-point scale, with 1 being poor/difficult and 10 being excellent/easy.	5 days of wear, lenses replaced daily	No
Primary	Overall Vision	Overall vision was interpreted and reported by the participant on a questionnaire as a single, retrospective evaluation of 5 days of wear. Overall vision was measured on a 10-point scale, with 1 being poor and 10 being excellent.	5 days of wear, lenses replaced daily	No
Secondary	Overall Fit	Overall lens fit was assessed by the investigator at study visit using a biomicroscope, which magnifies the appearance of the contact lens on the participant's eye. Lens fit was assessed by eye and graded on a 5-point scale, with 2=unacceptably loose, 1= acceptably loose, 0=optimal, -1=acceptably tight, and -2=unacceptably tight	Day 5, lenses replaced daily	No