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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Abbott Medical Optics

ClinicalTrials.gov Identifier:

NCT01240122

First received: November 8, 2010

Last updated: June 7, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 8, 2010

Last Updated Date

June 7, 2012

Start Date ^ICMJE

August 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Corneal Staining by Wear Time [ Time Frame: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4 ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

corneal staining [ Time Frame: end of day, Day 4 ] [ Designated as safety issue: Yes ]
Corneal staining was evaluated at the end of the day for of lens wear
Corneal staining [ Time Frame: 1 hour, Day 1 ] [ Designated as safety issue: Yes ]
Corneal staining was evaluated after 1 hour of lens wear on day 1
Corneal staining [ Time Frame: 2-hours, day two ] [ Designated as safety issue: Yes ]
Corneal staining was evaluated after 2 hours of lens wear on day 2
Corneal Staining [ Time Frame: 4 hours, Day 3 ] [ Designated as safety issue: Yes ]
Corneal staining was evaluated after 4 hours of lens wear on day 3

Change History

Complete list of historical versions of study NCT01240122 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Subjective Solution Preference [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Subject asked which solution they prefer based on comfort level.
Overall Ocular Comfort [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
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.

Original Secondary Outcome Measures ^ICMJE

Subjective solution preference [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Subject asked which solution they prefer based on comfort level.
Overall ocular comfort [ Time Frame: Day 4 ] [ Designated as safety issue: No ]
Subject asked about their comfort with level with both solutions.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Condition ^ICMJE

Corneal Staining

Intervention ^ICMJE

Device: Biotrue MPS
Multi-purpose contact lens care solution
Device: Investigational MPS
Multi-purpose contact lens care solution

Study Arm (s)

Active Comparator: Biotrue MPS
Intervention: Device: Biotrue MPS
Experimental: Investigational MPS
Intervention: Device: Investigational MPS

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2010

Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01240122

Other Study ID Numbers ^ICMJE

COBR-109-9608

Has Data Monitoring Committee

Not Provided

Responsible Party

Abbott Medical Optics

Study Sponsor ^ICMJE

Abbott Medical Optics

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Eugenia Y Kao, OD

AMO

Information Provided By

Abbott Medical Optics

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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