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

NCT ID: NCT01518868

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2012-02-29

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Investigational contact lens

multifocal high add soft contact lens

Group Type: EXPERIMENTAL

Investigational contact lens

Intervention Type: DEVICE

Worn on a daily wear basis for one week.

PureVision contact lens

Multi-focal contact lens

Group Type: ACTIVE_COMPARATOR

PureVision contact lens

Intervention Type: DEVICE

Worn on a daily wear basis for one week

Interventions

Investigational contact lens

Worn on a daily wear basis for one week.

Intervention Type: DEVICE

PureVision contact lens

Worn on a daily wear basis for one week

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beverly J Barna, CCRA

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb, Incorporated

Rochester, New York, United States

Countries

United States

Other Identifiers

743E

Identifier Type: -

Identifier Source: org_study_id