Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks - Full Text View

Purpose

The purpose of this study is to compare the overall performance of a monthly replacement contact lens when worn for one month and when worn for two weeks.

Condition	Intervention
Myopia Astigmatism Presbyopia	Device: lotrafilcon B contact lens

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

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:

Overall Comfort [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Overall Comfort [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Overall comfort was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Overall comfort was measured on a 10-point scale, with 1 being poor and 10 being excellent.
End of Day Dryness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
End of Day Dryness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
End of day dryness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. End of day dryness was measured on a 10-point scale, with 1 being very dry and 10 being not dry.
Ocular Redness [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.
Ocular Redness [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Ocular redness was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Ocular redness was measured on a 10-point scale, with 1 being very red and 10 being not red.
Visual Clarity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 2 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Visual Clarity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Visual clarity was assessed and reported by the participant on a questionnaire as a single, retrospective evaluation of 4 weeks of wear. Visual clarity was measured on a 10-point scale, with 1 being poor and 10 being excellent.
Lens Deposits [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.
Lens Deposits [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Protein and lipid deposits on the contact lens surface were assessed for each eye by the investigator using a biomicroscope, which magnifies the appearance of the contact lens on the wearer's eye. Deposits were graded on a scale of 0 to 4, with 0 being none and 4 being severe.
Corrected Visual Acuity [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.
Corrected Visual Acuity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Each eye was tested individually while the participant read distant charts in normal lighting. Corrected visual acuity was measured using a Snellen chart, which was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. Positive logMAR values indicate poorer vision, and negative values denote better visual acuity.

Enrollment:	117
Study Start Date:	December 2010
Study Completion Date:	April 2011
Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lotrafilcon B	Device: lotrafilcon B contact lens Commercially marketed, silicone hydrogel contact lens worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit. Other Name: AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM, AIR OPTIX® AQUA MULTIFOCAL

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Habitual and successful wearers of contact lenses made of lotrafilcon B material for at least 4 weeks prior to enrollment.
Good general health.
Sphere requirement in the range +6.00 to -10.00 with astigmatism or multifocal correction or no astigmatism or multifocal correction.
Ability to comply with all protocol-mandated procedures and to attend all scheduled office visits.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Anterior segment abnormalities (i.e., cataracts, opacities, etc.) or active anterior segment disease.
Administration of any investigational drug or device within 14 days of study initiation.
Use of any eye drops with a pharmacological effect within 7 days of Visit 1.
Known local or systemic hypersensitivity to contact lens cleaning and disinfecting solutions.
Post-refractive surgery.
Currently pregnant or lactating by case history.
Other protocol-defined exclusion criteria may apply.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:	NCT01293240 History of Changes
Other Study ID Numbers:	P-368-C-400
Study First Received:	February 9, 2011
Results First Received:	May 1, 2012
Last Updated:	June 26, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Astigmatism
Myopia
Presbyopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013