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

Study Description

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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

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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

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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

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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

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Ages Eligible for Study:	41 Years to 68 Years (Adult, Senior)
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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