Prospective Study of Lens Performance of a Monthly Replacement Lens at Two Weeks and Four Weeks
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myopia
- Sponsor
- CIBA VISION
- Enrollment
- 117
- Primary Endpoint
- Overall Comfort
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Overall Comfort
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.