Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis
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ClinicalTrials.gov Identifier: NCT01254760 |
Recruitment Status :
Completed
First Posted : December 7, 2010
Results First Posted : February 17, 2012
Last Update Posted : July 10, 2012
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Sponsor:
CIBA VISION
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
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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 |
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Presbyopia Myopia | Device: Nelfilcon A multifocal contact lens, investigational Device: Nelfilcon A multifocal contact lens, commercial | Not Applicable |
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 |
Resource links provided by the National Library of Medicine

Genetics Home Reference related topics:
Nearsightedness
MedlinePlus related topics:
Eye Wear
Arm | Intervention/treatment |
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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.
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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 |
Primary Outcome Measures :
- 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.
- 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.
- 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.
- 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 :
- 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
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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.
No Contacts or Locations Provided
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 Key Record Dates |
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 |