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

Phase 1

Completed

• Conditions: Astigmatism; Myopia; Hyperopia
• Interventions: Device: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)

• Registration Number: NCT01024855
• Lead Sponsor: Abbott Medical Optics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Results First Submitted: 2011-04-13
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-01
• Results First Posted: 2012-03-29
• Last Update Submitted: 2015-09-30
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RevitaLens OcuTec Multipurpose Solution (Investigational MPS)	RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)	-
Opti-Free RepleniSH Multipurpose Solution (MPS, Control)	RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control)	-

Primary Outcome Measures

Name	Time	Method
Number of Eyes With No Change in Corneal Staining	Change from baseline after 1, 2, 4 and 6+ hours of wear	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.

Trial Locations

Locations (1)

Abbott Medical Optics Inc.; 🇺🇸 Santa Ana, California, United States