Clinical trial NCT01959178: A Study to Evaluate a Mid Add Multi-Focal Soft Contact Lens
Official title: A Study to Evaluate a Mid Add Multi-Focal Soft Contact Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Mean Visual Acuity
timeFrame: At 1 Week follow up
Secondary outcomes:
measure: Symptoms/Complaints
timeFrame: At 1 Week follow up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Robert Stefffen
role: STUDY_DIRECTOR
References: