Trial Outcomes & Findings for Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution (NCT NCT00636363)

Last Updated: 2015-03-24

Results Overview

eyes with any slit lamp findings greater than Grade 2 at any visit. Slit lamp findings for each eye will be graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, superior tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be assessed.

Recruitment status

COMPLETED

Study phase

Target enrollment

541 participants

Primary outcome timeframe

Over 4 visits for 3 month period

Results posted on

2015-03-24

Participant Flow

541 participants were enrolled in this 3 month study (1152 eyes). First participant was enrolled Mar 7, 2008 and last participant exited Aug 1, 2008. Participant were enrolled from 24 investigative sites in the US.

Of the 541 participants enrolled 6 were ineligible at baseline. These subjects met the exclusion criteria. 535 participants participated in the study.

Participant milestones

Participant milestones
Measure	Multipurpose Solution - Rub Care Bausch \& Lomb Multipurpose Solution for use with contact lens care	Multipurpose Solution - No Rub Care Bausch \& Lomb Multipurpose Solution for use with contact lens care	Ciba Vision Aquify Multipurpose Solution Ciba Vision Aquify Multipurpose Solution for use with contact lens care
Overall Study STARTED	178	176	181
Overall Study COMPLETED	165	156	163
Overall Study NOT COMPLETED	13	20	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Multipurpose Solution - Rub Care Bausch \& Lomb Multipurpose Solution for use with contact lens care	Multipurpose Solution - No Rub Care Bausch \& Lomb Multipurpose Solution for use with contact lens care	Ciba Vision Aquify Multipurpose Solution Ciba Vision Aquify Multipurpose Solution for use with contact lens care
Overall Study Conjunctivitis	0	0	1
Overall Study Adverse Event	0	0	1
Overall Study Positive slit lamp finding	0	2	1
Overall Study Study related symptoms/complaints	8	7	4
Overall Study Met ineligibility criteria	0	0	3
Overall Study Missed > 1 visit	0	1	3
Overall Study Lack of motivation	1	0	1
Overall Study Protocol Violation	0	3	0
Overall Study Lost to Follow-up	3	4	2
Overall Study Withdrawal by Subject	1	3	2

Baseline Characteristics

Safety and Efficacy of a Bausch & Lomb Multipurpose Solution When Compared to Ciba Vision Aquify Multipurpose Solution

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Multipurpose Solution - Rub Care n=178 Participants Bausch \& Lomb Multipurpose Solution for use with contact lens care	Multipurpose Solution - No Rub Care n=176 Participants Bausch \& Lomb Multipurpose Solution for use with contact lens care	Ciba Vision Aquify Multipurpose Solution n=181 Participants Ciba Vision Aquify Multipurpose Solution for use with contact lens care	Total n=535 Participants Total of all reporting groups
Age, Customized 18-66 years of age	178 Participants n=5 Participants	176 Participants n=7 Participants	181 Participants n=5 Participants	535 Participants n=4 Participants
Sex: Female, Male Female	124 Participants n=5 Participants	133 Participants n=7 Participants	126 Participants n=5 Participants	383 Participants n=4 Participants
Sex: Female, Male Male	54 Participants n=5 Participants	43 Participants n=7 Participants	55 Participants n=5 Participants	152 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants	21 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	168 Participants n=5 Participants	172 Participants n=7 Participants	174 Participants n=5 Participants	514 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	178 participants n=5 Participants	176 participants n=7 Participants	181 participants n=5 Participants	535 participants n=4 Participants

PRIMARY outcome

Timeframe: Over 4 visits for 3 month period

Population: Over all follow-up visits, all dispensed eyes

Outcome measures

Outcome measures
Measure	Multipurpose Solution - Rub Care n=354 eyes Bausch \& Lomb Multipurpose Solution for use with contact lens care	Multipurpose Solution - No Rub Care n=352 eyes Bausch \& Lomb Multipurpose Solution for use with contact lens care	Ciba Vision Aquify Multipurpose Solution n=358 eyes Ciba Vision Aquify Multipurpose Solution for use with contact lens care
Slit-lamp Findings > Grade 2	3 participants	4 participants	3 participants

PRIMARY outcome

Timeframe: Over 4 visits for the 3 month period

Population: Comfort related symptoms/complaints for all eligible, dispensed eyes. Over all follow-up visits.

Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.

Outcome measures

Outcome measures
Measure	Multipurpose Solution - Rub Care n=352 eyes Bausch \& Lomb Multipurpose Solution for use with contact lens care	Multipurpose Solution - No Rub Care n=344 eyes Bausch \& Lomb Multipurpose Solution for use with contact lens care	Ciba Vision Aquify Multipurpose Solution n=352 eyes Ciba Vision Aquify Multipurpose Solution for use with contact lens care
Subjective Responses to Comfort Related Symptoms/Complaints Dryness	88.2 Scores on a Scale Standard Deviation 14.0	83.0 Scores on a Scale Standard Deviation 19.0	83.7 Scores on a Scale Standard Deviation 16.4
Subjective Responses to Comfort Related Symptoms/Complaints Redness	91.4 Scores on a Scale Standard Deviation 13.2	91.0 Scores on a Scale Standard Deviation 13.1	91.2 Scores on a Scale Standard Deviation 14.0
Subjective Responses to Comfort Related Symptoms/Complaints Vision	91.9 Scores on a Scale Standard Deviation 10.9	88.9 Scores on a Scale Standard Deviation 16.2	92.6 Scores on a Scale Standard Deviation 10.9
Subjective Responses to Comfort Related Symptoms/Complaints Lens cleanliness	92.2 Scores on a Scale Standard Deviation 11.7	89.2 Scores on a Scale Standard Deviation 15.3	91.8 Scores on a Scale Standard Deviation 10.8
Subjective Responses to Comfort Related Symptoms/Complaints Lens Handling	95.1 Scores on a Scale Standard Deviation 9.0	95.1 Scores on a Scale Standard Deviation 7.2	94.9 Scores on a Scale Standard Deviation 8.5
Subjective Responses to Comfort Related Symptoms/Complaints Comfort	88.7 Scores on a Scale Standard Deviation 12.9	84.6 Scores on a Scale Standard Deviation 16.5	86.9 Scores on a Scale Standard Deviation 13.9
Subjective Responses to Comfort Related Symptoms/Complaints End of day comfort	83.2 Scores on a Scale Standard Deviation 17.6	77.1 Scores on a Scale Standard Deviation 20.8	79.1 Scores on a Scale Standard Deviation 18.6
Subjective Responses to Comfort Related Symptoms/Complaints Burning/stinging upon inserstion	91.1 Scores on a Scale Standard Deviation 13.5	89.1 Scores on a Scale Standard Deviation 15.8	90.1 Scores on a Scale Standard Deviation 15.9
Subjective Responses to Comfort Related Symptoms/Complaints Irritation	88.7 Scores on a Scale Standard Deviation 15.3	85.0 Scores on a Scale Standard Deviation 17.4	86.8 Scores on a Scale Standard Deviation 15.2
Subjective Responses to Comfort Related Symptoms/Complaints Itching	91.6 Scores on a Scale Standard Deviation 12.7	90.9 Scores on a Scale Standard Deviation 12.9	90.8 Scores on a Scale Standard Deviation 14.1

PRIMARY outcome

Timeframe: At each visit for 3 months

Population: Lens deposits, All eligible, dispensed eyes.

Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.

Outcome measures

Outcome measures
Measure	Multipurpose Solution - Rub Care n=350 eyes Bausch \& Lomb Multipurpose Solution for use with contact lens care	Multipurpose Solution - No Rub Care n=338 eyes Bausch \& Lomb Multipurpose Solution for use with contact lens care	Ciba Vision Aquify Multipurpose Solution n=350 eyes Ciba Vision Aquify Multipurpose Solution for use with contact lens care
Contact Lens Deposits None	98 Eyes	52 Eyes	91 Eyes
Contact Lens Deposits Light	147 Eyes	176 Eyes	178 Eyes
Contact Lens Deposits Heavy	21 Eyes	26 Eyes	12 Eyes
Contact Lens Deposits Medium	84 Eyes	84 Eyes	69 Eyes

Adverse Events

Multipurpose Solution - Rub Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Multipurpose Solution - No Rub Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ciba Vision Aquify Multipurpose Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Robert Steffen

Bausch & Lomb

Phone: (585) 338-6399

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER