Evaluation of a Multi-Purpose Solution

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00710879
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arm: 1
• Duration (Months): 7.1
• Patients Per Site Per Month: 25.5

Study Details

Study Description

Brief Summary

This study evaluates a multi-purpose solution when used on a daily wear basis by currently adapted soft contact lens wearers.

Condition or Disease	Intervention/Treatment	Phase
Contact Lens Solutions	Device: Bausch & Lomb Multi-Purpose Solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Study to Evaluate the Clinical Performance of a Multi-Purpose Solution.
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Feb 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Multipurpose Solution Multi-purpose solution administered to adapted FDA group I soft contact lens wearers and FDA group IV soft contact lens wearers.	Device: Bausch & Lomb Multi-Purpose Solution; Daily care for contact lenses.

Outcome Measures

Primary Outcome Measures

1. Antimicrobial Efficacy [2 weeks, 3 months]

   Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae

Secondary Outcome Measures

1. Solution Related AE's and Lens Changes [3 months, 6 months]

   Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.

2. Solution Utlility [3 months, 6 months]

   The Utility was determined based on the results of the efficacy and safety evaluations.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Is an adapted Group I or Group IV soft contact lens wearer and agrees to wear the study lenses on a daily wear basis.

• Must be able and willing to comply with all treatment and follow-up study procedures.

• Must have a clear central cornea.

• VA correctable to 0.3 LogMar or better (driving vision)

Exclusion Criteria:

• Systemic disease affecting ocular health.

• Using systemic or topical medications.

• Wear monovision, multifocal or toric contact lenses.

• Any grade 2 or greater slit lamp findings.

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Nicholas Marsico	Torrance	California	United States	90505

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Bev Barna, Bausch & Lomb Incorporated

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00710879
• Other Study ID Numbers: 568
• First Posted: Jul 8, 2008
• Last Update Posted: Dec 13, 2011
• Last Verified: Dec 1, 2011

• Keywords provided by Bausch & Lomb Incorporated: Efficacy

Study Results

Participant Flow

Recruitment Details	First participant was enrolled in this study on 07/07/2008 and last subject exited on 02/02/2009. 180 participants were enrolled at 9 investigative sites in the United States.
Pre-assignment Detail	This study focused on participants of Japanese descent (at least one grandparent born in Japan) for a minimum of 20% of total enrollment. 180 participants were enrolled, 3 participants were ineligible at screening, 177 participants were eligible at the start of the study.

Arm/Group Title	Multi-purpose Solution and Optima 38 Lenses	Multi-Purpose Solution and Acuvue 2 Lenses
Arm/Group Description	Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.	B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
Period Title: Overall Study
STARTED	60	117
COMPLETED	58	113
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	Multi-purpose Solution and Optima 38 Lenses	Multi-Purpose Solution and Acuvue 2 Lenses	Total
Arm/Group Description	Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.	B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.	Total of all reporting groups
Overall Participants	60	117	177
Age, Customized (Number) [Number]
Aged 18-64	60 (11.0) 100%	117 (10.3) 100%	177 100%
Sex: Female, Male (Count of Participants)
Female	37 61.7%	75 64.1%	112 63.3%
Male	23 38.3%	42 35.9%	65 36.7%
Participants with Grandparents Born in Japan (Number) [Number]
1 Grandparent	0 0%	11 9.4%	11 6.2%
2 Grandparents	7 11.7%	18 15.4%	25 14.1%
3 Grandparents	4 6.7%	6 5.1%	10 5.6%
4 Grandparents	49 81.7%	82 70.1%	131 74%

Outcome Measures

1. Primary Outcome

Title	Antimicrobial Efficacy
Description	Excellent = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <0-103 CFU/mL. Good = No bacterial infection suspected and no ocular pathogens detected and bacteria of normal flora <103-105 CFU/mL. Skeptical = Bacterial infection suspected and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. No Efficacy = Bacterial infection definite and ocular pathogens detected and bacteria of normal flora ≥ 105 CFU/mL. Pathogens were H. aegyptius, H. influenzae, Moraxella spp., P. aeruginosa, S. pneumoniae, S. aureus, N. gonorrhoeae
Time Frame	2 weeks, 3 months

Outcome Measure Data

Analysis Population Description

All eligible, dispensed eyes with cultures taken within window. Group I subjects were cultured at the 3-Month Visit. Group IV subjects were cultured at the 2-week Follow-up visit.

Arm/Group Title	Multi-purpose Solution and Optima 38 Lenses	Multi-Purpose Solution and Acuvue 2 Lenses
Arm/Group Description	Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.	B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
Measure Participants	58	113
Measure eyes	115	226
Excellent	114	219
Good	0	3
Skeptical	1	4
No Efficacy	0	0

2. Secondary Outcome

Title	Solution Related AE's and Lens Changes
Description	Very Safe = No solution related AEs and no changes in lens properties related to the solution. Safe = No solution related AEs and slight change in lens properties related to the solution, but lens wear was continued. Skeptical = Solution related AEs were suspected and lens properties changed due to the solution and lens wear was discontinued. Not Safe = Solution related AEs were present and lens properties changed due to the solution and lens wear was discontinued.
Time Frame	3 months, 6 months

Outcome Measure Data

Analysis Population Description

All Eligible, Dispensed Eyes

Arm/Group Title	Multi-purpose Solution and Optima 38 Lenses	Multi-Purpose Solution and Acuvue 2 Lenses
Arm/Group Description	Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.	B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
Measure Participants	60	120
Measure eyes	120	240
Very Safe	118	238
Safe	2	2
Skeptical	0	0
Not Safe	0	0

3. Secondary Outcome

Title	Solution Utlility
Description	The Utility was determined based on the results of the efficacy and safety evaluations.
Time Frame	3 months, 6 months

Outcome Measure Data

Analysis Population Description

All Eligible, Dispensed Eyes

Arm/Group Title	Multi-purpose Solution and Optima 38 Lenses	Multi-Purpose Solution and Acuvue 2 Lenses
Arm/Group Description	Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.	B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
Measure Participants	58	117
Measure Eyes	115	234
Very Useful	112	225
Useful	2	5
Slightly Useful	1	4
Not Useful	0	0

Adverse Events

Time Frame	Adverse events were evaluated at every visit. Group 1, 3 months and group 4, 6 months.
Arm/Group Title	Multi-purpose Solution and Optima 38 Lenses		Multi-Purpose Solution and Acuvue 2 Lenses
Arm/Group Description	Multi-purpose solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group I contact lenses (Optima 38) with no scheduled replacement. Participants were followed for 3 months.		B&L Multi-Purpose Solution when used on a daily wear basis with United States (US) Food and Drug Administration (FDA) Group IV contact lenses (Acuvue 2) with scheduled replacements every 2 weeks. Participants were followed for 6 months.
All Cause Mortality
	Multi-purpose Solution and Optima 38 Lenses		Multi-Purpose Solution and Acuvue 2 Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Multi-purpose Solution and Optima 38 Lenses		Multi-Purpose Solution and Acuvue 2 Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/240 (0%)
Other (Not Including Serious) Adverse Events
	Multi-purpose Solution and Optima 38 Lenses		Multi-Purpose Solution and Acuvue 2 Lenses
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/120 (0%)		0/240 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed.