Ocular Discomfort
Conditions
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.
Interventions
Lens care product for disinfecting lenses on a daily basis.
DEVICECiba's Multi-Purpose Solution
Lens care product for disinfecting lenses on a daily basis.
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
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 details
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.
Participants by arm
| Arm | Count |
|---|---|
| Bausch & Lomb Multi-Purpose Solution Multi-Purpose Solution to be used for disinfecting contact lenses. | 153 |
| Ciba's Multi-Purpose Solution Multi-Purpose Solution to be used for disinfecting contact lenses. | 152 |
| Total | 305 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Eligible Participants | Ineligible | 0 | 1 |
| Eligible Participants | Lost to Follow-up | 0 | 1 |
| Eligible Participants | Withdrawal by Subject | 0 | 1 |
| Enrolled Participants | Ineligible at baseline | 3 | 4 |
Baseline characteristics
| Characteristic | Ciba's Multi-Purpose Solution | Total | Bausch & Lomb Multi-Purpose Solution |
|---|---|---|---|
| Age, Customized Between 18 and 70 years | 152 participants | 305 participants | 153 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 29 Participants | 14 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) White | 126 Participants | 257 Participants | 131 Participants |
| Sex: Female, Male Female | 112 Participants | 214 Participants | 102 Participants |
| Sex: Female, Male Male | 40 Participants | 91 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 156 | 0 / 156 |
| serious Total, serious adverse events | 0 / 156 | 0 / 156 |
Outcome results
Primary
Comfort-related Symptoms/Complaints
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.
Population: Summaries included all eligible, dispensed participants, with participants summarized under the study products received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bausch & Lomb Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Burning/stinging upon insertion | 91.4 Units on a scale | Standard Deviation 15.6 |
| Bausch & Lomb Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Itching | 91.2 Units on a scale | Standard Deviation 15.8 |
| Bausch & Lomb Multi-Purpose Solution | Comfort-related Symptoms/Complaints | End of Day Comfort | 81.7 Units on a scale | Standard Deviation 20.7 |
| Bausch & Lomb Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Dryness | 84.9 Units on a scale | Standard Deviation 20.6 |
| Bausch & Lomb Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Irritation | 88.2 Units on a scale | Standard Deviation 17.1 |
| Bausch & Lomb Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Redness | 90.7 Units on a scale | Standard Deviation 16.4 |
| Bausch & Lomb Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Comfort | 89.0 Units on a scale | Standard Deviation 14.2 |
| Ciba's Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Redness | 92.8 Units on a scale | Standard Deviation 13 |
| Ciba's Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Comfort | 88.3 Units on a scale | Standard Deviation 14.7 |
| Ciba's Multi-Purpose Solution | Comfort-related Symptoms/Complaints | End of Day Comfort | 81.9 Units on a scale | Standard Deviation 17.4 |
| Ciba's Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Burning/stinging upon insertion | 93.1 Units on a scale | Standard Deviation 14 |
| Ciba's Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Irritation | 89.3 Units on a scale | Standard Deviation 14.1 |
| Ciba's Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Itching | 94.3 Units on a scale | Standard Deviation 10.3 |
| Ciba's Multi-Purpose Solution | Comfort-related Symptoms/Complaints | Dryness | 85.4 Units on a scale | Standard Deviation 15.8 |
Secondary
Slit Lamp Findings
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
Population: Greater than grade 2 for all dispensed eyes with non-missing scores
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bausch & Lomb Multi-Purpose Solution | Slit Lamp Findings | 1 eyes |
| Ciba's Multi-Purpose Solution | Slit Lamp Findings | 3 eyes |