Adverse Effect of Contact Lens Solution
Conditions
Brief summary
To evaluate the product performance of a Bausch & Lomb Multipurpose solution when compared to Alcon OptiFree Replenish Multipurpose Solution
Interventions
DEVICEBausch & Lomb Multipurpose Solution
daily care of contact lenses
DEVICEAlcon OptiFree Replenish 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
* Subjects are adapted wearers of silicone hydrogel contact lenses * 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 a monovision, multifocal or toric contact lenses * Any grade 2 or greater slit lamp findings
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Assessment of Comfort and Cleanliness | 7 days | Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms and Complaints | 2 weeks | Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score. |
| Graded Slit Lamp Findings > Grade 2 | 2 week follow-up visit | Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2. |
Countries
Malaysia
Participant flow
Recruitment details
361 subjects (722 eyes) who are currently adapted silicone hydrogel contact lens wearers and are habitually using a lens care product for disinfecting lenses, were enrolled in this 2-Week study at approximately 14 investigative sites in Asia. Study start date was 2/16/2008 and last subject exited on 3/17/2008.
Pre-assignment details
Fourteen Investigators enrolled 361 subjects in the study. Of these subjects, 347 successfully completed the study, 3 discontinued and 11 were ineligible at baseline, but were dispensed study materials
Participants by arm
| Arm | Count |
|---|---|
| B&L Multipurpose Solution Bausch & Lomb Multipurpose Contact Lens Solution | 175 |
| Alcon Multipurpose Solution Alcon OptiFree Replenish Multipurpose Contact Lens Solution | 175 |
| Total | 350 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Study related symptoms and complaints | 1 | 0 |
Baseline characteristics
| Characteristic | B&L Multipurpose Solution | Alcon Multipurpose Solution | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 175 Participants | 175 Participants | 350 Participants |
| Race/Ethnicity, Customized Asian | 175 participants | 175 participants | 350 participants |
| Sex: Female, Male Female | 125 Participants | 121 Participants | 246 Participants |
| Sex: Female, Male Male | 50 Participants | 54 Participants | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 175 | 0 / 175 |
| serious Total, serious adverse events | 0 / 175 | 0 / 175 |
Outcome results
Primary
Subjective Assessment of Comfort and Cleanliness
Scale from 0-100 for each eye where 100=most favorable rating and 0=the least favorable rating.
Time frame: 7 days
Population: All eyes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| B&L Multipurpose Solution | Subjective Assessment of Comfort and Cleanliness | Cleanliness upon insertion | 89.71 Scores on a scale | Standard Deviation 14.52 |
| B&L Multipurpose Solution | Subjective Assessment of Comfort and Cleanliness | Comfort upon insertion | 87.45 Scores on a scale | Standard Deviation 15.56 |
| B&L Multipurpose Solution | Subjective Assessment of Comfort and Cleanliness | Cleanliness at end of day | 82.98 Scores on a scale | Standard Deviation 18.54 |
| B&L Multipurpose Solution | Subjective Assessment of Comfort and Cleanliness | Comfort at end of day | 80.14 Scores on a scale | Standard Deviation 19.41 |
| Alcon Multipurpose Solution | Subjective Assessment of Comfort and Cleanliness | Comfort at end of day | 79.60 Scores on a scale | Standard Deviation 19.41 |
| Alcon Multipurpose Solution | Subjective Assessment of Comfort and Cleanliness | Cleanliness upon insertion | 89.26 Scores on a scale | Standard Deviation 14.52 |
| Alcon Multipurpose Solution | Subjective Assessment of Comfort and Cleanliness | Cleanliness at end of day | 82.34 Scores on a scale | Standard Deviation 18.54 |
| Alcon Multipurpose Solution | Subjective Assessment of Comfort and Cleanliness | Comfort upon insertion | 86.63 Scores on a scale | Standard Deviation 15.56 |
Secondary
Graded Slit Lamp Findings > Grade 2
Grade none (no findings) - grade 4 (severe findings). Eyes in the Test group were compared with eyes in the Control group. Slit lamp finding greater than Grade 2.
Time frame: 2 week follow-up visit
Population: All dispensed, completed eyes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| B&L Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Corneal neovascularization | 0 eyes |
| B&L Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Limbal injection | 0 eyes |
| B&L Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Epithelial microcysts | 0 eyes |
| B&L Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Bulbar injection | 0 eyes |
| B&L Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Epithelial edema | 0 eyes |
| B&L Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Corneal staining | 3 eyes |
| B&L Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Corneal infiltrates | 0 eyes |
| B&L Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Superior tarsal conjunctival abnormalities | 0 eyes |
| Alcon Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Corneal infiltrates | 0 eyes |
| Alcon Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Superior tarsal conjunctival abnormalities | 0 eyes |
| Alcon Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Epithelial edema | 0 eyes |
| Alcon Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Epithelial microcysts | 0 eyes |
| Alcon Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Corneal staining | 0 eyes |
| Alcon Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Limbal injection | 0 eyes |
| Alcon Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Bulbar injection | 0 eyes |
| Alcon Multipurpose Solution | Graded Slit Lamp Findings > Grade 2 | Corneal neovascularization | 0 eyes |
Secondary
Symptoms and Complaints
Scores on a scale from 0 to 100, with 100 being the most favorable. Eyes with multiple unscheduled visits in a visit category were counted once for their lowest score.
Time frame: 2 weeks
Population: All eligible, dispensed eyes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| B&L Multipurpose Solution | Symptoms and Complaints | Comfort | 85.4 Score on a scale | Standard Deviation 14.7 |
| B&L Multipurpose Solution | Symptoms and Complaints | End of day comfort | 79.2 Score on a scale | Standard Deviation 16.7 |
| B&L Multipurpose Solution | Symptoms and Complaints | Burning/stinging upon insertion | 87.0 Score on a scale | Standard Deviation 18.7 |
| B&L Multipurpose Solution | Symptoms and Complaints | Irritation | 86.4 Score on a scale | Standard Deviation 18.7 |
| B&L Multipurpose Solution | Symptoms and Complaints | Itching | 89.2 Score on a scale | Standard Deviation 16.6 |
| B&L Multipurpose Solution | Symptoms and Complaints | Dryness | 80.6 Score on a scale | Standard Deviation 16.6 |
| B&L Multipurpose Solution | Symptoms and Complaints | Redness | 89.2 Score on a scale | Standard Deviation 15.8 |
| B&L Multipurpose Solution | Symptoms and Complaints | Vision | 89.8 Score on a scale | Standard Deviation 13.1 |
| B&L Multipurpose Solution | Symptoms and Complaints | Lens cleanliness | 86.6 Score on a scale | Standard Deviation 14.6 |
| B&L Multipurpose Solution | Symptoms and Complaints | Lens handling | 90.8 Score on a scale | Standard Deviation 11.4 |
| Alcon Multipurpose Solution | Symptoms and Complaints | Vision | 89.4 Score on a scale | Standard Deviation 12.5 |
| Alcon Multipurpose Solution | Symptoms and Complaints | Comfort | 86.1 Score on a scale | Standard Deviation 13.1 |
| Alcon Multipurpose Solution | Symptoms and Complaints | Dryness | 81.9 Score on a scale | Standard Deviation 15.7 |
| Alcon Multipurpose Solution | Symptoms and Complaints | End of day comfort | 79.3 Score on a scale | Standard Deviation 15.1 |
| Alcon Multipurpose Solution | Symptoms and Complaints | Lens handling | 90.4 Score on a scale | Standard Deviation 11 |
| Alcon Multipurpose Solution | Symptoms and Complaints | Burning/stinging upon insertion | 88.9 Score on a scale | Standard Deviation 14.8 |
| Alcon Multipurpose Solution | Symptoms and Complaints | Redness | 90.0 Score on a scale | Standard Deviation 12.7 |
| Alcon Multipurpose Solution | Symptoms and Complaints | Irritation | 88.2 Score on a scale | Standard Deviation 14.6 |
| Alcon Multipurpose Solution | Symptoms and Complaints | Lens cleanliness | 86.9 Score on a scale | Standard Deviation 13.1 |
| Alcon Multipurpose Solution | Symptoms and Complaints | Itching | 90.3 Score on a scale | Standard Deviation 13.2 |