A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens

Completed · Not applicable

Conditions studied: Presbyopia

In brief

The objective of this study is to evaluate the product performance of the investigational multifocal high add soft contact lens compared with PureVision Multi-focal contact lens on a daily wear basis.

Key facts

Study ID

NCT01518868

Run by

Bausch & Lomb Incorporated

People needed

126

Starts

2012-01-01

Expected to finish

2012-02-01

Last updated by the study team

2020-09-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have physiologically normal anterior segments
• Be adapted wearers of soft contact lenses and wear a lens in each eye.
• Be presbyopic and require near add correction in each eye.
• Be an adapted monovision or multifocal contact lens wearer or be an adapted spherical lens wearer who also uses spectacles for near vision correction.
• Have no active ocular disease or allergic conjunctivitis.
• Must not be using any topical ocular medications.
• Must habitually use a lens care product for lens cleaning, disinfecting, and storage.

You may not qualify if…

• Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
• Anisometropia (spherical equivalent) of greater than 2.00 D.
• Any systemic disease affecting ocular health.
• Using any systemic or topical medications that will affect ocular physiology or lens performance.
• Allergic to any component in the study products.
• Ocular astigmatism of greater than 1.00 D in either eye.
• Have had any corneal surgery (ie, refractive surgery).
• Uses AMO Ultra Care as their habitual lens care regimen.
• Is a toric contact lens wearer.
• Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
• An active ocular disease (for example but not limited to papillary conjunctivitis, any conjunctivitis: viral, bacterial, allergic), any corneal infiltrative response or are using any ocular medications.

Where it is running

• Bausch & Lomb, Incorporated — Rochester, New York, United States

Full record on ClinicalTrials.gov

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