An interventional study of Bausch & Lomb Multipurpose Solution - Rub Care and Bausch & Lomb Multipurpose Solution - No Rub Care in Contact Lens Solutions, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-24.
Sponsored by Bausch & Lomb Incorporated · Not applicable, Interventional, and Supportive care
To the safety and efficacy of a Bausch \& Lomb Multipurpose Solution when compared to Ciba vision Aquify Multipurpose solution
Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Bausch \& Lomb Multipurpose Solution for use with contact lens care
Device: Bausch & Lomb Multipurpose Solution - Rub Care
Bausch \& Lomb Multipurpose Solution for use with contact lens care
Device: Bausch & Lomb Multipurpose Solution - No Rub Care
Ciba Vision Aquify Multipurpose Solution for use with contact lens care
Device: Ciba Vision Aquify Multipurpose Solution
Daily care for contact lenses - rub care regimen
Daily care for contact lenses - no rub care regimen
daily care for contact lenses
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
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
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
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.
| Milestone | Multipurpose Solution - Rub Care | Multipurpose Solution - No Rub Care | Ciba Vision Aquify Multipurpose Solution |
|---|---|---|---|
| Started | 178 | 176 | 181 |
| Completed | 165 | 156 | 163 |
| Not completed | 13 | 20 | 18 |
| Withdrew: Conjunctivitis | 0 | 0 | 1 |
| Withdrew: Adverse event | 0 | 0 | 1 |
| Withdrew: Positive slit lamp finding | 0 | 2 | 1 |
| Withdrew: Study related symptoms/complaints | 8 | 7 | 4 |
| Withdrew: Met ineligibility criteria | 0 | 0 | 3 |
| Withdrew: Missed > 1 visit | 0 | 1 | 3 |
| Withdrew: Lack of motivation | 1 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 3 | 0 |
| Withdrew: Lost to follow-up | 3 | 4 | 2 |
| Withdrew: Withdrawal by subject | 1 | 3 | 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.
| participants | Multipurpose Solution - Rub Care | Multipurpose Solution - No Rub Care | Ciba Vision Aquify Multipurpose Solution |
|---|---|---|---|
| Slit-lamp Findings > Grade 2 | 3 | 4 | 3 |
Subject symptoms/complaints will be assessed on a scale from 0 to 100, with 0 denoting unfavorable symptoms/complaints.
| Scores on a Scale | Multipurpose Solution - Rub Care | Multipurpose Solution - No Rub Care | Ciba Vision Aquify Multipurpose Solution |
|---|---|---|---|
| Comfort | 88.7 ± 12.9 | 84.6 ± 16.5 | 86.9 ± 13.9 |
| End of day comfort | 83.2 ± 17.6 | 77.1 ± 20.8 | 79.1 ± 18.6 |
| Burning/stinging upon inserstion | 91.1 ± 13.5 | 89.1 ± 15.8 | 90.1 ± 15.9 |
| Irritation | 88.7 ± 15.3 | 85.0 ± 17.4 | 86.8 ± 15.2 |
| Itching | 91.6 ± 12.7 | 90.9 ± 12.9 | 90.8 ± 14.1 |
| Dryness | 88.2 ± 14.0 | 83.0 ± 19.0 | 83.7 ± 16.4 |
| Redness | 91.4 ± 13.2 | 91.0 ± 13.1 | 91.2 ± 14.0 |
| Vision | 91.9 ± 10.9 | 88.9 ± 16.2 | 92.6 ± 10.9 |
| Lens cleanliness | 92.2 ± 11.7 | 89.2 ± 15.3 | 91.8 ± 10.8 |
| Lens Handling | 95.1 ± 9.0 | 95.1 ± 7.2 | 94.9 ± 8.5 |
Lens deposits assessed at each follow-up visit. Degree of deposits assessed as none, light, medium, or heavy.
| Eyes | Multipurpose Solution - Rub Care | Multipurpose Solution - No Rub Care | Ciba Vision Aquify Multipurpose Solution |
|---|---|---|---|
| None | 98 | 52 | 91 |
| Light | 147 | 176 | 178 |
| Medium | 84 | 84 | 69 |
| Heavy | 21 | 26 | 12 |
Collected over 3 Months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multipurpose Solution - Rub Care | — | 0/178 (0%) | 0/178 (0%) |
| Multipurpose Solution - No Rub Care | — | 0/176 (0%) | 0/176 (0%) |
| Ciba Vision Aquify Multipurpose Solution | — | 0/181 (0%) | 0/181 (0%) |
| Age, Customized(Participants) | Multipurpose Solution - Rub Care | Multipurpose Solution - No Rub Care | Ciba Vision Aquify Multipurpose Solution | Total |
|---|---|---|---|---|
| 18-66 years of age | 178 | 176 | 181 | 535 |
| Sex: Female, Male(Participants) | Multipurpose Solution - Rub Care | Multipurpose Solution - No Rub Care | Ciba Vision Aquify Multipurpose Solution | Total |
|---|---|---|---|---|
| Female | 124 | 133 | 126 | 383 |
| Male | 54 | 43 | 55 | 152 |
| Ethnicity (NIH/OMB)(Participants) | Multipurpose Solution - Rub Care | Multipurpose Solution - No Rub Care | Ciba Vision Aquify Multipurpose Solution | Total |
|---|---|---|---|---|
| Hispanic or Latino | 10 | 4 | 7 | 21 |
| Not Hispanic or Latino | 168 | 172 | 174 | 514 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Multipurpose Solution - Rub Care | Multipurpose Solution - No Rub Care | Ciba Vision Aquify Multipurpose Solution | Total |
|---|---|---|---|---|
| United States | 178 | 176 | 181 | 535 |
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Bausch & Lomb Incorporated