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

NCT ID: NCT01959178

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-08-31

Brief Summary

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.

Conditions

Presbyopia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

LD127025 MF

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

Group Type: EXPERIMENTAL

LD127025 MF

Intervention Type: DEVICE

At Visit 1, one-half of the subjects will be randomized to receive the investigational soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the control soft contact lens.

Air Optix Aqua MF

Intervention Type: DEVICE

At Visit 1, one-half of the subjects will be randomized to receive the control soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the investigational soft contact lens.

Air Optix Aqua MF

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

Group Type: ACTIVE_COMPARATOR

LD127025 MF

Intervention Type: DEVICE

At Visit 1, one-half of the subjects will be randomized to receive the investigational soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the control soft contact lens.

Air Optix Aqua MF

Intervention Type: DEVICE

At Visit 1, one-half of the subjects will be randomized to receive the control soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the investigational soft contact lens.

Interventions

LD127025 MF

At Visit 1, one-half of the subjects will be randomized to receive the investigational soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the control soft contact lens.

Intervention Type: DEVICE

Air Optix Aqua MF

At Visit 1, one-half of the subjects will be randomized to receive the control soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the investigational soft contact lens.

Intervention Type: DEVICE

Eligibility 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.

• 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

Robert Stefffen

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb Incorporated

Rochester, New York, United States

Countries

United States

Other Identifiers

825E

Identifier Type: -

Identifier Source: org_study_id