Contact Lens Solutions
Conditions
Brief summary
To the safety and efficacy of a Bausch & Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution
Interventions
DEVICEBausch & Lomb Multipurpose Solution - Rub Care
Daily care for contact lenses - rub care regimen
DEVICEBausch & Lomb Multipurpose Solution - No Rub Care
Daily care for contact lenses - no rub care regimen
DEVICECiba Vision Aquify Multipurpose Solution
daily care for contact lenses
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subject is a habitual wearer of a silicone hydrogel or group IV contact lens * VA correctable to 0.3 LogMar or better (driving vision) * Clear central cornea * Subject uses a lens care system on a regular basis
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Responses to Comfort Related Symptoms/Complaints | Over 4 visits for the 3 month period | Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints. |
| Contact Lens Deposits | At each visit for 3 months | Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy. |
| Slit-lamp Findings > Grade 2 | Over 4 visits for 3 month period | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Of the 541 participants enrolled 6 were ineligible at baseline. These subjects met the exclusion criteria. 535 participants participated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Multipurpose Solution - Rub Care Bausch & Lomb Multipurpose Solution for use with contact lens care | 178 |
| Multipurpose Solution - No Rub Care Bausch & Lomb Multipurpose Solution for use with contact lens care | 176 |
| Ciba Vision Aquify Multipurpose Solution Ciba Vision Aquify Multipurpose Solution for use with contact lens care | 181 |
| Total | 535 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Conjunctivitis | 0 | 0 | 1 |
| Overall Study | Lack of motivation | 1 | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 4 | 2 |
| Overall Study | Met ineligibility criteria | 0 | 0 | 3 |
| Overall Study | Missed > 1 visit | 0 | 1 | 3 |
| Overall Study | Positive slit lamp finding | 0 | 2 | 1 |
| Overall Study | Protocol Violation | 0 | 3 | 0 |
| Overall Study | Study related symptoms/complaints | 8 | 7 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 2 |
Baseline characteristics
| Characteristic | Multipurpose Solution - Rub Care | Multipurpose Solution - No Rub Care | Ciba Vision Aquify Multipurpose Solution | Total |
|---|---|---|---|---|
| Age, Customized 18-66 years of age | 178 Participants | 176 Participants | 181 Participants | 535 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 4 Participants | 7 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants | 172 Participants | 174 Participants | 514 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 178 participants | 176 participants | 181 participants | 535 participants |
| Sex: Female, Male Female | 124 Participants | 133 Participants | 126 Participants | 383 Participants |
| Sex: Female, Male Male | 54 Participants | 43 Participants | 55 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 178 | 0 / 176 | 0 / 181 |
| serious Total, serious adverse events | 0 / 178 | 0 / 176 | 0 / 181 |
Outcome results
Primary
Contact Lens Deposits
Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.
Time frame: At each visit for 3 months
Population: Lens deposits, All eligible, dispensed eyes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Multipurpose Solution - Rub Care | Contact Lens Deposits | Light | 147 Eyes |
| Multipurpose Solution - Rub Care | Contact Lens Deposits | None | 98 Eyes |
| Multipurpose Solution - Rub Care | Contact Lens Deposits | Medium | 84 Eyes |
| Multipurpose Solution - Rub Care | Contact Lens Deposits | Heavy | 21 Eyes |
| Multipurpose Solution - No Rub Care | Contact Lens Deposits | Heavy | 26 Eyes |
| Multipurpose Solution - No Rub Care | Contact Lens Deposits | Light | 176 Eyes |
| Multipurpose Solution - No Rub Care | Contact Lens Deposits | Medium | 84 Eyes |
| Multipurpose Solution - No Rub Care | Contact Lens Deposits | None | 52 Eyes |
| Ciba Vision Aquify Multipurpose Solution | Contact Lens Deposits | Medium | 69 Eyes |
| Ciba Vision Aquify Multipurpose Solution | Contact Lens Deposits | Light | 178 Eyes |
| Ciba Vision Aquify Multipurpose Solution | Contact Lens Deposits | None | 91 Eyes |
| Ciba Vision Aquify Multipurpose Solution | Contact Lens Deposits | Heavy | 12 Eyes |
Primary
Slit-lamp Findings > Grade 2
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.
Time frame: Over 4 visits for 3 month period
Population: Over all follow-up visits, all dispensed eyes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Multipurpose Solution - Rub Care | Slit-lamp Findings > Grade 2 | 3 participants |
| Multipurpose Solution - No Rub Care | Slit-lamp Findings > Grade 2 | 4 participants |
| Ciba Vision Aquify Multipurpose Solution | Slit-lamp Findings > Grade 2 | 3 participants |
Primary
Subjective Responses to Comfort Related Symptoms/Complaints
Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
Time frame: Over 4 visits for the 3 month period
Population: Comfort related symptoms/complaints for all eligible, dispensed eyes. Over all follow-up visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Multipurpose Solution - Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Comfort | 88.7 Scores on a Scale | Standard Deviation 12.9 |
| Multipurpose Solution - Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | End of day comfort | 83.2 Scores on a Scale | Standard Deviation 17.6 |
| Multipurpose Solution - Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Burning/stinging upon inserstion | 91.1 Scores on a Scale | Standard Deviation 13.5 |
| Multipurpose Solution - Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Irritation | 88.7 Scores on a Scale | Standard Deviation 15.3 |
| Multipurpose Solution - Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Itching | 91.6 Scores on a Scale | Standard Deviation 12.7 |
| Multipurpose Solution - Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Dryness | 88.2 Scores on a Scale | Standard Deviation 14 |
| Multipurpose Solution - Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Redness | 91.4 Scores on a Scale | Standard Deviation 13.2 |
| Multipurpose Solution - Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Vision | 91.9 Scores on a Scale | Standard Deviation 10.9 |
| Multipurpose Solution - Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Lens cleanliness | 92.2 Scores on a Scale | Standard Deviation 11.7 |
| Multipurpose Solution - Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Lens Handling | 95.1 Scores on a Scale | Standard Deviation 9 |
| Multipurpose Solution - No Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Lens cleanliness | 89.2 Scores on a Scale | Standard Deviation 15.3 |
| Multipurpose Solution - No Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Comfort | 84.6 Scores on a Scale | Standard Deviation 16.5 |
| Multipurpose Solution - No Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Dryness | 83.0 Scores on a Scale | Standard Deviation 19 |
| Multipurpose Solution - No Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Itching | 90.9 Scores on a Scale | Standard Deviation 12.9 |
| Multipurpose Solution - No Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | End of day comfort | 77.1 Scores on a Scale | Standard Deviation 20.8 |
| Multipurpose Solution - No Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Lens Handling | 95.1 Scores on a Scale | Standard Deviation 7.2 |
| Multipurpose Solution - No Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Vision | 88.9 Scores on a Scale | Standard Deviation 16.2 |
| Multipurpose Solution - No Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Burning/stinging upon inserstion | 89.1 Scores on a Scale | Standard Deviation 15.8 |
| Multipurpose Solution - No Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Redness | 91.0 Scores on a Scale | Standard Deviation 13.1 |
| Multipurpose Solution - No Rub Care | Subjective Responses to Comfort Related Symptoms/Complaints | Irritation | 85.0 Scores on a Scale | Standard Deviation 17.4 |
| Ciba Vision Aquify Multipurpose Solution | Subjective Responses to Comfort Related Symptoms/Complaints | Vision | 92.6 Scores on a Scale | Standard Deviation 10.9 |
| Ciba Vision Aquify Multipurpose Solution | Subjective Responses to Comfort Related Symptoms/Complaints | Irritation | 86.8 Scores on a Scale | Standard Deviation 15.2 |
| Ciba Vision Aquify Multipurpose Solution | Subjective Responses to Comfort Related Symptoms/Complaints | Itching | 90.8 Scores on a Scale | Standard Deviation 14.1 |
| Ciba Vision Aquify Multipurpose Solution | Subjective Responses to Comfort Related Symptoms/Complaints | Dryness | 83.7 Scores on a Scale | Standard Deviation 16.4 |
| Ciba Vision Aquify Multipurpose Solution | Subjective Responses to Comfort Related Symptoms/Complaints | Lens cleanliness | 91.8 Scores on a Scale | Standard Deviation 10.8 |
| Ciba Vision Aquify Multipurpose Solution | Subjective Responses to Comfort Related Symptoms/Complaints | Redness | 91.2 Scores on a Scale | Standard Deviation 14 |
| Ciba Vision Aquify Multipurpose Solution | Subjective Responses to Comfort Related Symptoms/Complaints | Comfort | 86.9 Scores on a Scale | Standard Deviation 13.9 |
| Ciba Vision Aquify Multipurpose Solution | Subjective Responses to Comfort Related Symptoms/Complaints | Lens Handling | 94.9 Scores on a Scale | Standard Deviation 8.5 |
| Ciba Vision Aquify Multipurpose Solution | Subjective Responses to Comfort Related Symptoms/Complaints | End of day comfort | 79.1 Scores on a Scale | Standard Deviation 18.6 |
| Ciba Vision Aquify Multipurpose Solution | Subjective Responses to Comfort Related Symptoms/Complaints | Burning/stinging upon inserstion | 90.1 Scores on a Scale | Standard Deviation 15.9 |