A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01024751
• Collaborator: (none)
• Enrollment: 312
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 103.2

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the clinical performance of Bausch & Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV contact lenses.

Condition or Disease	Intervention/Treatment	Phase
Ocular Discomfort	Device: Bausch & Lomb Multi-Purpose Solution; Device: Ciba's Multi-Purpose Solution	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 312 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jan 1, 2010
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bausch & Lomb Multi-Purpose Solution Multi-Purpose Solution to be used for disinfecting contact lenses.	Device: Bausch & Lomb Multi-Purpose Solution; Lens care product for disinfecting lenses on a daily basis.
Active Comparator: Ciba's Multi-Purpose Solution Multi-Purpose Solution to be used for disinfecting contact lenses.	Device: Ciba's Multi-Purpose Solution; Lens care product for disinfecting lenses on a daily basis.

Outcome Measures

Primary Outcome Measures

1. Comfort-related Symptoms/Complaints [At dispensing visit and each follow-up visit at week 2 and week 4.]

   Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.

Secondary Outcome Measures

1. Slit Lamp Findings [Over all visits for 1 month]

   Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.

• Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.

• Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.

• Participants must agree to wear study lenses on a daily wear basis.

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

Exclusion Criteria:

• Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.

• Participants with any systemic disease affecting ocular health.

• Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.

• Participants who have had any corneal surgery (eg, refractive surgery).

• Participants who are allergic to any component in the study care products.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bausch & Lomb	Rochester	New York	United States	14609

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01024751
• Other Study ID Numbers: 636
• First Posted: Dec 3, 2009
• Last Update Posted: Aug 15, 2011
• Last Verified: Jul 1, 2011

• Additional relevant MeSH terms: Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	This one month study was conducted at 20 sites by 20 investigators in the United States. First participant was enrolled 11/30/2009 and last Participants visit was 1/22/2010.
Pre-assignment Detail	312 participants(624 eyes) started the study, 7 of which were ineligible at baseline, one was non-dispensed. 305(610 eyes) participants were eligible. 3 participants were discontinued during the study. 302 participants (604 eyes) completed the study.

Arm/Group Title	Bausch & Lomb Multi-Purpose Solution	Ciba's Multi-Purpose Solution
Arm/Group Description	Multi-Purpose Solution to be used for disinfecting contact lenses.	Multi-Purpose Solution to be used for disinfecting contact lenses.
Period Title: Enrolled Participants
STARTED	156	156
COMPLETED	153	152
NOT COMPLETED	3	4
Period Title: Enrolled Participants
STARTED	153	152
COMPLETED	153	149
NOT COMPLETED	0	3

Baseline Characteristics

Arm/Group Title	Bausch & Lomb Multi-Purpose Solution	Ciba's Multi-Purpose Solution	Total
Arm/Group Description	Multi-Purpose Solution to be used for disinfecting contact lenses.	Multi-Purpose Solution to be used for disinfecting contact lenses.	Total of all reporting groups
Overall Participants	153	152	305
Age, Customized (participants) [Number]
Between 18 and 70 years	153 100%	152 100%	305 100%
Sex: Female, Male (Count of Participants)
Female	102 66.7%	112 73.7%	214 70.2%
Male	51 33.3%	40 26.3%	91 29.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	14 9.2%	15 9.9%	29 9.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	7 4.6%	6 3.9%	13 4.3%
White	131 85.6%	126 82.9%	257 84.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 0.7%	5 3.3%	6 2%

Outcome Measures

1. Primary Outcome

Title	Comfort-related Symptoms/Complaints
Description	Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.
Time Frame	At dispensing visit and each follow-up visit at week 2 and week 4.

Outcome Measure Data

Analysis Population Description

Summaries included all eligible, dispensed participants, with participants summarized under the study products received.

Arm/Group Title	Bausch & Lomb Multi-Purpose Solution	Ciba's Multi-Purpose Solution
Arm/Group Description	Multi-Purpose Solution to be used for disinfecting contact lenses.	Multi-Purpose Solution to be used for disinfecting contact lenses.
Measure Participants	153	151
Measure eyes	306	302
Comfort	89.0 (14.2)	88.3 (14.7)
End of Day Comfort	81.7 (20.7)	81.9 (17.4)
Burning/stinging upon insertion	91.4 (15.6)	93.1 (14.0)
Irritation	88.2 (17.1)	89.3 (14.1)
Itching	91.2 (15.8)	94.3 (10.3)
Dryness	84.9 (20.6)	85.4 (15.8)
Redness	90.7 (16.4)	92.8 (13.0)

2. Secondary Outcome

Title	Slit Lamp Findings
Description	Graded slit lamp findings for each eye greater than grade 2 included epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates. Slit lamp findings are grade on a scale of 0-4 with 0=none and 4=severe. Over All Follow-up Visits summarizes the worst case over all follow-up visits.
Time Frame	Over all visits for 1 month

Outcome Measure Data

Analysis Population Description

Greater than grade 2 for all dispensed eyes with non-missing scores

Arm/Group Title	Bausch & Lomb Multi-Purpose Solution	Ciba's Multi-Purpose Solution
Arm/Group Description	Multi-Purpose Solution to be used for disinfecting contact lenses.	Multi-Purpose Solution to be used for disinfecting contact lenses.
Measure Participants	156	153
Measure eyes	312	306
Number [eyes]	1	3

Adverse Events

Time Frame	1 month
Adverse Event Reporting Description	Adverse events measured by eye
Arm/Group Title	Bausch & Lomb Multi-Purpose Solution		Ciba's Multi-Purpose Solution
Arm/Group Description	Multi-Purpose Solution to be used for disinfecting contact lenses.		Multi-Purpose Solution to be used for disinfecting contact lenses.
All Cause Mortality
	Bausch & Lomb Multi-Purpose Solution		Ciba's Multi-Purpose Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bausch & Lomb Multi-Purpose Solution		Ciba's Multi-Purpose Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/156 (0%)
Other (Not Including Serious) Adverse Events
	Bausch & Lomb Multi-Purpose Solution		Ciba's Multi-Purpose Solution
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/156 (0%)		0/156 (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 and the Investigator(s) 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.