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OpenTrials
Completed

NCT Number: NCT01959178

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Mean Visual Acuity

    Time frame: At 1 Week follow up

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

Secondary outcomes

  1. Symptoms/Complaints

    Time frame: At 1 Week follow up

    Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 9, 2013
Registry last updated
Sep 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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