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

Study Overview
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Brief Summary
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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.

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

Conditions
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Myopia, Astigmatism, Presbyopia

Intervention / Treatment
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* Device: lotrafilcon B contact lens


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lotrafilcon B<br> | Device: lotrafilcon B contact lens<br>* 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.<br>* Other names: AIR OPTIX® AQUA, AIR OPTIX® for ASTIGMATISM, AIR OPTIX® AQUA MULTIFOCAL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Comfort | 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. | 2 weeks | 
| Overall Comfort | 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. | 4 weeks | 
| End of Day Dryness | 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. | 2 weeks | 
| End of Day Dryness | 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. | 4 weeks | 
| Ocular Redness | 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. | 2 weeks | 
| Ocular Redness | 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. | 4 weeks | 
| Visual Clarity | 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. | 2 weeks | 
| Visual Clarity | 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. | 4 weeks | 
| Lens Deposits | 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. | 2 weeks | 
| Lens Deposits | 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. | 4 weeks | 
| Corrected Visual Acuity | 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. | 2 weeks | 
| Corrected Visual Acuity | 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. | 4 weeks |