Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions

A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia; Hyperopia
• Intervention / Treatment: Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Ana, California, United States, 92705
      • Abbott Medical Optics Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• were at least 18 years old;
• were experienced contact lens wearers;
• were correctable to at least 20/40 or better in both eyes with contact lenses;
• were in good general health, with healthy eyes (other than requiring vision correction);
• had not worn lenses for at least 12 hours before each baseline visit;
• had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
• had previously used an MPS or hydrogen peroxide solution successfully.

Exclusion Criteria:

• had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
• required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
• had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
• were currently participating in any other clinical study;
• had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RevitaLens OcuTec Multipurpose Solution (Investigational MPS)	Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control); multi-purpose lens care solution
Active Comparator: Opti-Free RepleniSH Multipurpose Solution (MPS, Control)	Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control); multi-purpose lens care solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Eyes With No Change in Corneal Staining	Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.	Change from baseline after 1, 2, 4 and 6+ hours of wear

Collaborators and Investigators

• Sponsor: Abbott Medical Optics

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: December 2, 2009
• First Posted (Estimate): December 3, 2009

Study Record Updates

• Last Update Posted (Estimate): October 20, 2015
• Last Update Submitted That Met QC Criteria: September 30, 2015
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Hyperopia
• Other Study ID Numbers: COBR-106-9608