NCT01518868CompletedNot Applicable
A Study to Evaluate the Feasibility of a High Add Multi Focal Contact Lens
Bausch & Lomb Incorporated2 sites in 1 country126 target enrollmentStarted: January 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 126
- Locations
- 2
- Primary Endpoint
- Visual Acuity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Visual Acuity
Time Frame: At 2 weeks follow up
Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).
Secondary Outcomes
- Symptoms/Complaints(At 2 weeks follow up)
Investigators
Study Sites (2)
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