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

• Sponsor: Abbott Medical Optics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01240122
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 9.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Corneal Staining	Device: Biotrue MPS; Device: Investigational MPS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Subjective Solution Preference [Day 4]

   All subjects were asked which solution they prefer based on comfort level: Biotrue MPS, Investigational MPS, or no difference.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abbott Medical Optics Inc	Santa Ana	California	United States	92705

Sponsors and Collaborators

• Abbott Medical Optics

Investigators

• Principal Investigator: Eugenia Y Kao, OD, AMO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT01240122
• Other Study ID Numbers: COBR-109-9608
• First Posted: Nov 15, 2010
• Last Update Posted: Feb 6, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Abbott Medical Optics: Corneal staining and comfort evaluation in normal, habitual contact lens wearers.

Study Results

Participant Flow

Arm/Group Title	Biotrue/Investigational MPS
Arm/Group Description	Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
Period Title: Overall Study
STARTED	29
COMPLETED	29
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Biotrue/Investigational MPS
Arm/Group Description	Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
Overall Participants	29
Age, Customized (participants) [Number]
<18 years	0 0%
18 years of age or older	29 100%
Sex/Gender, Customized (participants) [Number]
Male	0 0%
Female	0 0%
Unknown	29 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

Corneal Staining Severity at Scheduled Visits (Safety Population)

Arm/Group Title	Biotrue	Investigational MPS
Arm/Group Description	Paired/parallel eye evaluation; each subject was treated with Biotrue, and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.	Paired/parallel eye evaluation; each subject used both used the Investigational MPS and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
Measure Participants	29	29
Staining at 1 Hour, Day 1	19 65.5%	15 NaN
Staining at 2 Hours, Day 2	19 65.5%	7 NaN
Staining at 4 Hours, Day 3	21 72.4%	5 NaN
Staining at End of Day, Day 4	18 62.1%	8 NaN

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

All subjects who completed the study were included in the analysis per protocol.

Arm/Group Title	Biotrue MPS	Investigational MPS
Arm/Group Description	Paired/parallel eye evaluation; each subject was treated with Biotrue multi-purpose solution in one eye, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.	Paired/parallel eye evaluation; each subject used Investigational MPS in the alternate eye and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
Measure Participants	28	28
Subject preferred the solution	6 20.7%	7 NaN
Subject did not prefer the solution	7 24.1%	6 NaN
Subject reported solutions were about the same	15 51.7%	15 NaN

3. Secondary Outcome

Title	Overall Ocular Comfort
Description	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.
Time Frame	Day 4

Outcome Measure Data

Analysis Population Description

All subjects who completed the study were included in the analysis per protocol.

Arm/Group Title	Biotrue	Investigational MPS
Arm/Group Description	Paired/parallel eye evaluation; each subject was treated with Biotrue MPS in one eye, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.	Paired/parallel eye evaluation; each subject used the Investigational MPS in the alternate eye, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
Measure Participants	29	29
Mean (Standard Deviation) [score on a scale]	8.3 (1.74)	8.4 (1.48)

Adverse Events

Arm/Group Title	Biotrue/Investigational MPS
Arm/Group Description	Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
All Cause Mortality
	Biotrue/Investigational MPS
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Biotrue/Investigational MPS
	Affected / at Risk (%)	# Events
Total	0/29 (0%)
Other (Not Including Serious) Adverse Events
	Biotrue/Investigational MPS
	Affected / at Risk (%)	# Events
Total	0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.