Status:
COMPLETED
A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Presbyopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT01518868
Start Date
January 1 2012
End Date
February 1 2012
Last Update
September 30 2020
Active Locations (1)
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1
Bausch & Lomb, Incorporated
Rochester, New York, United States, 14609