Comparison of Two Multifocal Contact Lenses

Presbyopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250054
• Other study ID #: P-319-C-018
• Status: Completed
• Phase: N/A
• First received: November 29, 2010
• Last updated: June 26, 2012
• Start date: October 2010
• Est. completion date: October 2010

Study information

• Verified date: July 2011
• 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 compare two multifocal contact lenses in presbyopic wearers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• At least 35 years of age.

• Sign written Informed Consent

• Spectacle add of +0.50 to +2.50D.

• Best corrected visual acuity of at least 20.30 in both eyes.

• Currently wearing soft contact lenses at least 5 days per week.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Eye injury or surgery within twelve weeks of enrollment.

• Currently enrolled in any clinical trial.

• Astigmatism > 1.00D.

• Strabismus/amblyopia.

• 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

• Presbyopia

Intervention

Device:
• Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
• Comfilcon A contact lens
Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear 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	Overall vision, as interpreted by the participant and recorded by the investigator as a single, retrospective evaluation of one week's wear time. Overall vision was measured on a 10-point scale, with 1 being worst and 10 being best.	One week of wear	No