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

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.

Study Overview

• Status: Completed
• Conditions: Corneal Staining
• Intervention / Treatment: Device: Biotrue MPS; Device: Investigational MPS

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

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 and older (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: OTHER
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Biotrue MPS	Device: Biotrue MPS; Multi-purpose contact lens care solution
EXPERIMENTAL: Investigational MPS	Device: Investigational MPS; Multi-purpose contact lens care solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Staining by Wear Time	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.	1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Solution Preference	All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference.	Day 4
Overall Ocular Comfort	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.	Day 4

Collaborators and Investigators

• Sponsor: Abbott Medical Optics
• Investigators: Principal Investigator: Eugenia Y Kao, OD, AMO

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): November 1, 2010

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 10, 2010
• First Posted (ESTIMATE): November 15, 2010

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Corneal staining and comfort evaluation in normal, habitual contact lens wearers.
• Other Study ID Numbers: COBR-109-9608