Myopia
Conditions
Brief summary
The objective of this study is to evaluate the safety and efficacy of the Bausch & Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).
Interventions
DEVICEBausch & Lomb contact lens
Bausch & Lomb daily disposable cosmetic tint contact lens
DEVICEMarketed daily disposable contact lens
Marketed daily disposable cosmetic tint contact lens
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must have clear central corneas and be free of any anterior segment disorders. * Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand. * Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye. * Subjects must be of Asian descent. * Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.
Exclusion criteria
* Subjects who have any systemic disease affecting ocular health. * Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance. * Subjects with an active ocular disease or are using any ocular medication. * Subjects with any Present finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear. * Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study. * Subjects who currently wear monovision, multifocal, or toric contact lenses. * Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Slit Lamp Findings | Summarized over all follow-up visits through 1 month | Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) \> grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe |
| logMAR Visual Acuity (VA) | Summarized over all visits, and dispensed visit | Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Centration | Summarized over all follow-up visits through 1 month | Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift). Suboptimal lens centration was defined as a rating other than excellent. |
| Lens Wettability | Summarized over all follow-up visits through 1 month | Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (\< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas \> 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits. |
| Symptoms & Complaints | Summarized over all follow-up visits through one month | Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score. |
| Lens Movement | Summarized over all follow-up visits through one month | Lens movement was assessed as adequate, excessive (\> 0.6 mm), insufficient (\< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate. |
| Lens Deposits | Summarized over all follow-up visits through one month | Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month |
Countries
United States
Participant flow
Recruitment details
200 Asian participants (400 eyes) who were adapted wearers of soft contact lenses were enrolled in this 1-month study at approximately 10 investigative sites in Asia and the United States. First participant was enrolled 4/12/2010 and last participant exited the study 08/09/2010
Pre-assignment details
Of the 200 participants (400 eyes) enrolled and dispensed lenses, 172 participants (344 eyes) completed the study
Participants by arm
| Arm | Count |
|---|---|
| Bausch & Lomb Contact Lens Bausch & Lomb daily disposable cosmetic tint contact lens | 100 |
| Marketed Daily Disposable Contact Lens Marketed daily disposable cosmetic tint contact lens | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Ineligibility criteria | 5 | 2 |
| Overall Study | Protocol Violation | 10 | 10 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Bausch & Lomb Contact Lens | Marketed Daily Disposable Contact Lens | Total |
|---|---|---|---|
| Age, Customized Between 18 and 62 years | 100 participants | 100 participants | 200 participants |
| Race/Ethnicity, Customized Asian Decent | 100 participants | 100 participants | 200 participants |
| Sex: Female, Male Female | 74 Participants | 76 Participants | 150 Participants |
| Sex: Female, Male Male | 26 Participants | 24 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
logMAR Visual Acuity (VA)
Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit
Time frame: 2 week and 1 month follow-up
Population: All eligible, dispensed eyes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bausch & Lomb Contact Lens | logMAR Visual Acuity (VA) | 2 week visit | 0.010 logMAR | Standard Deviation 0.046 |
| Bausch & Lomb Contact Lens | logMAR Visual Acuity (VA) | 1 month visit | 0.003 logMAR | Standard Deviation 0.043 |
| Marketed Daily Disposable Contact Lens | logMAR Visual Acuity (VA) | 2 week visit | -0.004 logMAR | Standard Deviation 0.046 |
| Marketed Daily Disposable Contact Lens | logMAR Visual Acuity (VA) | 1 month visit | -0.013 logMAR | Standard Deviation 0.043 |
Primary
logMAR Visual Acuity (VA)
Non-inferiority of distance high contrast logMAR lens VA. A negative value indicates improved VA. Lens VA was established for All Study, Dispensed, 2-Week Follow-up Visit, and 1-Month Follow-up Visit
Time frame: Summarized over all visits, and dispensed visit
Population: All eligible, dispensed eyes
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bausch & Lomb Contact Lens | logMAR Visual Acuity (VA) | All study visits | 0.006 logMAR | Standard Deviation 0.039 |
| Bausch & Lomb Contact Lens | logMAR Visual Acuity (VA) | Dispensed visit | 0.006 logMAR | Standard Deviation 0.048 |
| Marketed Daily Disposable Contact Lens | logMAR Visual Acuity (VA) | All study visits | -0.009 logMAR | Standard Deviation 0.039 |
| Marketed Daily Disposable Contact Lens | logMAR Visual Acuity (VA) | Dispensed visit | -0.010 logMAR | Standard Deviation 0.048 |
Primary
Slit Lamp Findings
Graded Slit lamp findings (epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates) \> grade 2 over all follow-up visits, summarizes the worst case over all follow-up visits. Graded 0-4 with 0=none and 4=severe
Time frame: Summarized over all follow-up visits through 1 month
Population: All dispensed eyes with any slit lamp findings \> grade 2
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bausch & Lomb Contact Lens | Slit Lamp Findings | 0 eyes |
| Marketed Daily Disposable Contact Lens | Slit Lamp Findings | 0 eyes |
Secondary
Lens Centration
Lens centration was assessed as excellent(fully centered), good (slight decentration, no corneal exposure), fair (decentration, intermittent corneal exposure), or poor (incomplete corneal coverage and/or edge lift). Suboptimal lens centration was defined as a rating other than excellent.
Time frame: Summarized over all follow-up visits through 1 month
Population: All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bausch & Lomb Contact Lens | Lens Centration | Excellent | 127 eyes |
| Bausch & Lomb Contact Lens | Lens Centration | Good | 31 eyes |
| Bausch & Lomb Contact Lens | Lens Centration | Fair | 13 eyes |
| Bausch & Lomb Contact Lens | Lens Centration | Poor | 1 eyes |
| Marketed Daily Disposable Contact Lens | Lens Centration | Poor | 15 eyes |
| Marketed Daily Disposable Contact Lens | Lens Centration | Excellent | 129 eyes |
| Marketed Daily Disposable Contact Lens | Lens Centration | Fair | 6 eyes |
| Marketed Daily Disposable Contact Lens | Lens Centration | Good | 26 eyes |
Secondary
Lens Deposits
Degree of lens deposits was assessed as none, light, medium, or heavy. Suboptimal lens deposits were defined as a degree rating of medium or heavy. Measured over all visits through one month
Time frame: Summarized over all follow-up visits through one month
Population: All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bausch & Lomb Contact Lens | Lens Deposits | None | 152 eyes |
| Bausch & Lomb Contact Lens | Lens Deposits | Light | 20 eyes |
| Bausch & Lomb Contact Lens | Lens Deposits | Medium | 0 eyes |
| Bausch & Lomb Contact Lens | Lens Deposits | Heavy | 0 eyes |
| Marketed Daily Disposable Contact Lens | Lens Deposits | Heavy | 0 eyes |
| Marketed Daily Disposable Contact Lens | Lens Deposits | None | 151 eyes |
| Marketed Daily Disposable Contact Lens | Lens Deposits | Medium | 0 eyes |
| Marketed Daily Disposable Contact Lens | Lens Deposits | Light | 23 eyes |
Secondary
Lens Movement
Lens movement was assessed as adequate, excessive (\> 0.6 mm), insufficient (\< 0.2 mm), or adherence. Suboptimal lens movement was defined as a rating other than adequate.
Time frame: Summarized over all follow-up visits through one month
Population: All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bausch & Lomb Contact Lens | Lens Movement | Adequate | 167 eyes |
| Bausch & Lomb Contact Lens | Lens Movement | Excessive | 0 eyes |
| Bausch & Lomb Contact Lens | Lens Movement | Insufficient | 5 eyes |
| Bausch & Lomb Contact Lens | Lens Movement | Adherence | 0 eyes |
| Marketed Daily Disposable Contact Lens | Lens Movement | Adherence | 0 eyes |
| Marketed Daily Disposable Contact Lens | Lens Movement | Adequate | 152 eyes |
| Marketed Daily Disposable Contact Lens | Lens Movement | Insufficient | 6 eyes |
| Marketed Daily Disposable Contact Lens | Lens Movement | Excessive | 18 eyes |
Secondary
Lens Wettability
Lens wettability was rated as Grade 4-0. Grade 4 = 100% of anterior surface wettable (optimal); Grade 3 = presence of small (\< 0.1 mm), individual, discrete non-wetting areas (slight); Grade 2 = presence of single area of non-wetting between 0.1 mm and 0.5 mm in size (mild); Grade 1 = presence of several areas on non-wetting, each between 0.1 mm and 0.5 mm in size (moderate); Grade 0 = presence of one or more non-wetting areas \> 0.5 mm in size (severe). Suboptimal lens wettability was defined as a rating other than Grade 4, ie slight, mild, moderate, or severe ratings. Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
Time frame: Summarized over all follow-up visits through 1 month
Population: All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bausch & Lomb Contact Lens | Lens Wettability | Slight | 41 eyes |
| Bausch & Lomb Contact Lens | Lens Wettability | Moderate | 0 eyes |
| Bausch & Lomb Contact Lens | Lens Wettability | Mild | 2 eyes |
| Bausch & Lomb Contact Lens | Lens Wettability | Severe | 0 eyes |
| Bausch & Lomb Contact Lens | Lens Wettability | Optimal | 129 eyes |
| Marketed Daily Disposable Contact Lens | Lens Wettability | Severe | 0 eyes |
| Marketed Daily Disposable Contact Lens | Lens Wettability | Optimal | 134 eyes |
| Marketed Daily Disposable Contact Lens | Lens Wettability | Slight | 39 eyes |
| Marketed Daily Disposable Contact Lens | Lens Wettability | Mild | 3 eyes |
| Marketed Daily Disposable Contact Lens | Lens Wettability | Moderate | 0 eyes |
Secondary
Symptoms & Complaints
Subject symptoms/complaints were assessed on a scale from 0 to 100, with 0 denoting least favorable symptoms/complaints and 100 being the most favorable score.
Time frame: Summarized over all follow-up visits through one month
Population: All eligible dispensed eyes, summarized over all follow-up visits through 1 month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Irritation | 87.4 units on a scale | Standard Deviation 12.9 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Lens Handling Upon Removal | 92.1 units on a scale | Standard Deviation 10.1 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Itching | 89.3 units on a scale | Standard Deviation 13.3 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | End of Day Comfort | 82.0 units on a scale | Standard Deviation 15.1 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Dryness | 82.1 units on a scale | Standard Deviation 15.7 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Burning Stinging Upon Insertion | 90.3 units on a scale | Standard Deviation 12.9 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Redness | 89.4 units on a scale | Standard Deviation 12.8 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Lens Awareness | 88.7 units on a scale | Standard Deviation 12.9 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Vision | 89.6 units on a scale | Standard Deviation 11.4 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Overall Impression | 87.5 units on a scale | Standard Deviation 12.8 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Lens Handling Upon Insertion | 89.2 units on a scale | Standard Deviation 13 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Lens Cleanliness | 91.9 units on a scale | Standard Deviation 8.4 |
| Bausch & Lomb Contact Lens | Symptoms & Complaints | Comfort | 87.1 units on a scale | Standard Deviation 13.1 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Overall Impression | 80.1 units on a scale | Standard Deviation 12.8 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Burning Stinging Upon Insertion | 84.6 units on a scale | Standard Deviation 12.9 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Comfort | 83.1 units on a scale | Standard Deviation 13.1 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | End of Day Comfort | 77.3 units on a scale | Standard Deviation 15.1 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Lens Awareness | 80.6 units on a scale | Standard Deviation 12.9 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Lens Cleanliness | 89.2 units on a scale | Standard Deviation 8.4 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Irritation | 82.8 units on a scale | Standard Deviation 12.9 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Itching | 84.6 units on a scale | Standard Deviation 13.3 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Dryness | 77.9 units on a scale | Standard Deviation 15.6 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Redness | 85.4 units on a scale | Standard Deviation 12.8 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Vision | 87.9 units on a scale | Standard Deviation 11.4 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Lens Handling Upon Insertion | 83.3 units on a scale | Standard Deviation 13 |
| Marketed Daily Disposable Contact Lens | Symptoms & Complaints | Lens Handling Upon Removal | 87.9 units on a scale | Standard Deviation 10.1 |