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

• ClinicalTrials.gov Identifier: NCT01254760
• Recruitment Status: Completed
• First Posted: December 7, 2010
• Results First Posted: February 17, 2012
• Last Update Posted: July 10, 2012
• Sponsor: CIBA VISION
• Information provided by (Responsible Party): Alcon Research ( CIBA VISION )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Presbyopia; Myopia	Device: Nelfilcon A multifocal contact lens, investigational; Device: Nelfilcon A multifocal contact lens, commercial	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 79 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: December 2010
• Actual Primary Completion Date: January 2011
• Actual Study Completion Date: January 2011

Arms and Interventions

Arm	Intervention/treatment
Investigational multifocal / Commercial multifocal; Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.	Device: Nelfilcon A multifocal contact lens, investigational; Investigational, soft, multifocal contact lens for daily wear, daily disposable use.; Device: Nelfilcon A multifocal contact lens, commercial; Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.; Other Name: Focus® DAILIES® Progressive
Commercial multifocal / Investigational multifocal; Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.	Device: Nelfilcon A multifocal contact lens, investigational; Investigational, soft, multifocal contact lens for daily wear, daily disposable use.; Device: Nelfilcon A multifocal contact lens, commercial; Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.; Other Name: Focus® DAILIES® Progressive

Outcome Measures

Primary Outcome Measures :

1. End of Day Comfort [ Time Frame: 5 days of wear, lenses replaced daily ]
   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.
2. End of Day Dryness [ Time Frame: 5 days of wear, lenses replaced daily ]
   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.
3. Handling at Removal [ Time Frame: 5 days of wear, lenses replaced daily ]
   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.
4. Overall Vision [ Time Frame: 5 days of wear, lenses replaced daily ]
   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.

Secondary Outcome Measures :

1. Overall Fit [ Time Frame: Day 5, lenses replaced daily ]
   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

Eligibility Criteria

• Ages Eligible for Study: 41 Years to 68 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: CIBA VISION
• ClinicalTrials.gov Identifier: NCT01254760 History of Changes
• Other Study ID Numbers: P-416-C-001 Sub 04
• First Posted: December 7, 2010
• Results First Posted: February 17, 2012
• Last Update Posted: July 10, 2012
• Last Verified: January 2012

Additional relevant MeSH terms:

Presbyopia; Refractive Errors; Eye Diseases