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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01293240

Enrollment

117

Registered

2011-02-10

Start date

2010-12-31

Completion date

2011-04-30

Last updated

2012-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia, Astigmatism, Presbyopia

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.

Interventions

DEVICElotrafilcon 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Comfort	2 weeks	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.
End of Day Dryness	2 weeks	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.
Ocular Redness	2 weeks	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.
Visual Clarity	2 weeks	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.
Lens Deposits	2 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	2 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.

Participant flow

Participants by arm

Arm	Count
Lotrafilcon B Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.	117
Total	117

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Noncompliance	2

Baseline characteristics

Characteristic	Lotrafilcon B
Age Continuous	45.8 years STANDARD_DEVIATION 12.6
Gender Female	79 participants
Gender Male	36 participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 117
serious Total, serious adverse events	0 / 117

Outcome results

Primary

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.

Time frame: 2 weeks