Comparison of Two Multifocal Contact Lenses Worn on a Daily Disposable Basis - Full Text View

Purpose

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

Condition	Intervention
Presbyopia Myopia	Device: Nelfilcon A multifocal contact lens, investigational Device: Nelfilcon A multifocal contact lens, commercial


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:

End of Day Comfort [ Time Frame: 5 days of wear, lenses replaced daily ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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


Enrollment:	79
Study Start Date:	December 2010
Study Completion Date:	January 2011
Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


Ages Eligible for Study:	41 Years to 68 Years
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information

No publications provided


Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01254760 History of Changes
Other Study ID Numbers:	P-416-C-001 Sub 04
Study First Received:	December 3, 2010
Results First Received:	January 17, 2012
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on March 03, 2015