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

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: LD127025 MF; Device: Air Optix Aqua MF

• Registration Number: NCT01959178
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2013-07
• Study Completion: 2013-08
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-09
• Results First Submitted: 2020-08-21
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Results First Posted: 2020-09-30
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
LD127025 MF	Air Optix Aqua MF	Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week.
Air Optix Aqua MF	Air Optix Aqua MF	Medium add daily disposable soft contact lens worn on a daily wear basis for one week.
LD127025 MF	LD127025 MF	Mid add daily disposable soft contact lens worn on a daily wear basis for 1 week.
Air Optix Aqua MF	LD127025 MF	Medium add daily disposable soft contact lens worn on a daily wear basis for one week.

Primary Outcome Measures

Name	Time	Method
Mean Visual Acuity	At 1 Week follow up	Visual acuity was assessed by distance high contrast logarithm of the minimum angle of resolution (logMAR).

Secondary Outcome Measures

Name	Time	Method
Symptoms/Complaints	At 1 Week follow up	Symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.

Trial Locations

Locations (1)

Bausch & Lomb Incorporated; 🇺🇸 Rochester, New York, United States