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

NCT01959178 | Completed Results

• 1 other identifier: 825E
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mean Visual Acuity

  Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

  At 1 Week follow up

Secondary Outcomes (1)

• Symptoms/Complaints

  At 1 Week follow up

Study Arms (2)

LD127025 MF

EXPERIMENTAL

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

Device: LD127025 MF; Device: Air Optix Aqua MF

Air Optix Aqua MF

ACTIVE COMPARATOR

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

Device: LD127025 MF; Device: Air Optix Aqua MF

Interventions

LD127025 MF 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; LD127025 MF

Air Optix Aqua MF 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; LD127025 MF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Study Director
• Organization: Bausch Health

robert.steffen@bausch.com

Study Officials

• Robert Stefffen

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 9, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: August 1, 2013
• Last Updated: September 30, 2020
• Results First Posted: September 30, 2020

Record last verified: 2020-09

Locations

US (1)