Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks

Not Applicable

Completed

• Conditions: Myopia; Astigmatism; Presbyopia

• Registration Number: NCT01293240
• Lead Sponsor: CIBA VISION

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2012-05
• Results First Submitted: 2012-05-01
• Results First Submitted QC: 2012-05-01
• Results First Posted: 2012-06-01
• Last Update Submitted: 2012-06-26
• Last Update Posted: 2012-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Overall Comfort	4 weeks	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	4 weeks	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	4 weeks	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	4 weeks	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	4 weeks	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	4 weeks	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.