A Study to Evaluate a Mid Add Multi-Focal Soft Contact Lens

Bausch + Lomb

Status: Completed

Conditions: Presbyopia

Treatments: Device: Air Optix Aqua MF; Device: LD127025 MF

Study type: Interventional

Funder types: Industry

Identifiers

NCT01959178

825E

Details and patient eligibility

About

This study is to evaluate the product performance of the investigational LD127025 MF mid add soft contact lens compared to CIBA Vision's Air Optix Aqua MF MED add soft contact lenses when used among currently adapted soft contact lens wearers.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Have physiologically normal anterior segments not exhibiting biomicroscopy findings Grade 2 or greater and/or presence of infiltrates.
• Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
• Be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye.
• Require contact lens correction from -5.00 D to +3.00 D in each eye.
• Be Presbyopic and require near add correction from +1.00 D to +1.75 D in each eye.
• Be an adapted monovision soft contact lens wearer or multifocal soft contact lens wearer or an adapted spherical soft contact lens wearer who also uses spectacles for near vision correction.
• Be willing to use a lens care system as required by the lens replacement schedule.
• Has a distance spherical equivalent refraction between -5.50 D and +3.00 D.

Exclusion Criteria:

• Not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
• Participated in any drug or device clinical investigation (within 14 days) prior to entry into this study and/or during the period of study participation.
• Women of childbearing potential if one of the following: pregnant, plans to become pregnant during study, is breast-feeding.
• Any Grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible.
• Any scar or neovascularization within the central 4mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
• 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.
• Aphakic.
• Amblyopic.
• Allergic to any component in the study care products.
• Meet any of the following criteria:
• Ophthalmologist, OD, Optician, Ophthalmologist's Assistant/Technician
• employee of a market research firm
• employee of manufacturer of contact lens or contact lens care products
• Ocular astigmatism of greater than 1.00 D in either eye.
• Have had any corneal surgery (ie, refractive surgery).
• Toric contact lens wearer.
• Have worn gas permeable (GP) contact lenses within the last 30 days or PMMA lenses within the last 3 months.
• Have an active ocular disease or are using any ocular medication.
• Have any systemic disease currently affecting ocular health or which, in the Investigator's opinion, may have an effect on ocular health during the course of the study.
• Using any systemic medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

LD127025 MF

Experimental group

Description:

Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week.

Treatment:

Device: Air Optix Aqua MF

Device: LD127025 MF

Air Optix Aqua MF

Active Comparator group

Description:

Medium add daily disposable soft contact lens worn on a daily wear basis for one week.

Treatment:

Device: Air Optix Aqua MF

Device: LD127025 MF