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

Not Applicable

Completed

• Conditions: Corneal Staining
• Interventions: Device: Biotrue MPS; Device: Investigational MPS

• Registration Number: NCT01240122
• Lead Sponsor: Abbott Medical Optics

Brief Summary

An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue 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: 2010-08-31
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-15
• Primary Completion: 2010-11-30
• Study Completion: 2010-11-30
• Results First Submitted: 2012-02-15
• Results First Submitted QC: 2012-06-07
• Results First Posted: 2012-06-11
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03

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: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Biotrue MPS	Biotrue MPS	-
Investigational MPS	Investigational MPS	-

Primary Outcome Measures

Name	Time	Method
Corneal Staining by Wear Time	1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4	All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.

Secondary Outcome Measures

Name	Time	Method
Subjective Solution Preference	Day 4	All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference.
Overall Ocular Comfort	Day 4	All subjects were asked to rate their lens comfort at each visit based on an 11 point scale where 0 meant that the lens could not be tolerated and 10 indicated that the lens could not be felt.

Trial Locations

Locations (1)

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