Evaluation of an Investigational Multi-Purpose Solution (MPS)

Phase 3

Completed

• Conditions: Study Focus is Healthy Contact Lens Wearers
• Interventions: Device: Investigational MPS; Device: Opti-Free

• Registration Number: NCT00961051
• Lead Sponsor: Abbott Medical Optics

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-07-27
• Primary Completion: 2009-08
• Study First Submitted QC: 2009-08-17
• Study First Posted: 2009-08-18
• Study Completion: 2009-11
• Results First Submitted: 2013-05-16
• Status Verified: 2013-12
• Results First Submitted QC: 2013-12-06
• Last Update Submitted: 2013-12-06
• Results First Posted: 2014-01-07
• Last Update Posted: 2014-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational MPS	Investigational MPS	Investigational multipurpose disinfecting solution (study MPS)
Predicate MPS	Opti-Free	Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)

Primary Outcome Measures

Name	Time	Method
Mean Lens Cleanliness as Measured by Light Reflectance	Day 30	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).

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With no Corneal Staining	Day 180	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.

Trial Locations

Locations (9)

Ziegler Leffingwell Eyecare; 🇺🇸 West Allis, Wisconsin, United States

Central Ohio Eyecare; 🇺🇸 Columbus, Ohio, United States

Insight Eyecare; 🇺🇸 Warrensburg, Missouri, United States

Eye Care Associates of Hawaii; 🇺🇸 Waipahu, Hawaii, United States

Northeastern Eye Institute; 🇺🇸 Scranton, Pennsylvania, United States

Complete Family Vision Center; 🇺🇸 San Diego, California, United States

Western Reserve Vision Care; 🇺🇸 Beachwood, Ohio, United States

West Bay Eye Associates; 🇺🇸 Warwick, Rhode Island, United States

Drs. Quinn, Quinn & Associates; 🇺🇸 Athens, Ohio, United States