Multifocal Contact Lens Use in Previous Contact Lens Wearers With Near Vision Demands

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the use of a multifocal contact lens in people who previously wore contact lenses but discontinued due to age-related, near vision demands.

Official Title
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P/331/09/C: Multifocal Pilot Study: Refitting Drop Outs (GARM)

Conditions
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Presbyopia

Intervention / Treatment
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* Device: lotrafilcon B multifocal contact lens
* Device: lotrafilcon B single vision contact lens
* Other: Over-reader spectacles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: has discontinued contact lens wear primarily due to age-related, near vision demands requires a reading add of +0.50 to +1.75 D (inclusive) and is correctable to at least 6/9 monocular, distance and near with spectacle correction has had an ocular examination in the last 2 years Other protocol-defined inclusion/exclusion criteria may apply Exclusion Criteria: has any ocular disease has more than a 2.00D prescription difference between eyes cannot be fit successfully with the study contact lenses has any systemic disease affecting ocular health is using any systemic or topical medications that may affect ocular health has undergone corneal refractive surgery Other protocol-defined inclusion/exclusion criteria may apply
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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Multifocal CL / Single vision CL + reading glasses<br>Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis. | Device: lotrafilcon B multifocal contact lens<br>* Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use<br>Device: lotrafilcon B single vision contact lens<br>* Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use<br>Other: Over-reader spectacles<br>* Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis<br>|
| Other: Single vision CL + reading glasses / Multifocal CL<br>Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis. | Device: lotrafilcon B multifocal contact lens<br>* Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use<br>Device: lotrafilcon B single vision contact lens<br>* Commercially marketed, silicone hydrogel, single vision contact lens for daily wear use<br>Other: Over-reader spectacles<br>* Reading glasses worn over single vision contact lenses for near vision work on an as-needed basis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Satisfaction With the Lenses | Overall satisfaction with the lenses was interpreted by and assessed by the subject as a single, retrospective measurement of one week's wear time. Overall satisfaction with the lenses was recorded on a questionnaire as a numerical rating on a scale of 1 to 100, with 1 being completely dissatisfied, and 100 being excellent, completely satisfied. | 1 week of wear |