Evaluation of an Investigational Multi-Purpose Solution (MPS)

Abbott Medical Optics270 enrolled

Overview

The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.

A new multi-purpose solution has been developed for optimal lens disinfection and lens wearing comfort, compatible with a wide variety of commercially available lenses. Ten investigative sites were selected to evaluate 274 soft contact lens wearers in a parallel group study of one investigational multi-purpose solution and one marketed predicate solution.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

270

Conditions

Study Focus is Healthy Contact Lens Wearers

Interventions

Investigational MPSDEVICE

Multi-purpose solution

Opti-FreeDEVICE

Multi-purpose solution

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Have successfully worn hydrogel contact lenses of the same material to be worn during the study * Have normal eyes (with the exception of unaided visual acuity) * Have successfully used a multi-purpose contact lens care solution * Have acceptable visual acuity and lens wearing comfort at time of enrollment Exclusion Criteria: * Concurrently enrolled another clinical trial * Have a known sensitivity to any study product ingredient(s) * Have a condition that may put them at significant risk

Locations (9)

Complete Family Vision Center

San Diego, California, United States

Eye Care Associates of Hawaii

Waipahu, Hawaii, United States

Insight Eyecare

Warrensburg, Missouri, United States

Drs. Quinn, Quinn & Associates

Outcomes

Primary Outcomes

Mean Lens Cleanliness as Measured by Light Reflectance

Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).

Time frame: Day 30

Secondary Outcomes

Number of Subjects With no Corneal Staining

Corneal staining was performed via slit lamp observation of the corneal through a cobalt blue filter and a yellow #12 or #15 filter Wratten filter following contact lens removal and installation of standard sodium fluorescein.

Time frame: Day 180

Data from ClinicalTrials.gov

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