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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bausch & Lomb contact lens | Experimental | Bausch & Lomb daily disposable cosmetic tint contact lens |
|
| Marketed daily disposable contact lens | Active Comparator | Marketed daily disposable cosmetic tint contact lens |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bausch & Lomb contact lens | Device | Bausch & Lomb daily disposable cosmetic tint contact lens |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Summarized over all follow-up visits through 1 month |
| 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 | Summarized over all visits, and dispensed visit |
| 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 | 2 week and 1 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bev Barna | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb | Rochester | New York | 14609 | United States |
Of the 200 participants (400 eyes) enrolled and dispensed lenses, 172 participants (344 eyes) completed the study
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Bausch & Lomb Contact Lens | Bausch & Lomb daily disposable cosmetic tint contact lens |
| FG001 | Marketed Daily Disposable Contact Lens | Marketed daily disposable cosmetic tint contact lens |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All participants were randomized and dispensed lenses at the baseline visit.
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| ID | Title | Description |
|---|---|---|
| BG000 | Bausch & Lomb Contact Lens | Bausch & Lomb daily disposable cosmetic tint contact lens |
| BG001 | Marketed Daily Disposable Contact Lens | Marketed daily disposable cosmetic tint contact lens |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | All dispensed eyes with any slit lamp findings > grade 2 | Posted | Number | eyes | Summarized over all follow-up visits through 1 month | eyes | Participants |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bausch & Lomb Contact Lens | Bausch & Lomb daily disposable cosmetic tint contact lens |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Steffen | Bausch & Lomb Inc. | (585) 338-6399 | robert.steffens@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Marketed daily disposable contact lens | Device | Marketed daily disposable cosmetic tint contact lens |
|
| Summarized over all follow-up visits through 1 month |
| 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 | Summarized over all follow-up visits through one month |
| 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. | Summarized over all follow-up visits through 1 month |
| 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. | Summarized over all follow-up visits through one month |
| 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. | Summarized over all follow-up visits through one month |
| Ineligibility criteria |
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| BG002 | Total | Total of all reporting groups |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
Marketed daily disposable cosmetic tint contact lens
|
|
| 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 | All eligible, dispensed eyes | Posted | Mean | Standard Deviation | logMAR | Summarized over all visits, and dispensed visit | eyes | Participants |
|
|
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| 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. | All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits. | Posted | Number | eyes | Summarized over all follow-up visits through 1 month | eyes | Participants |
|
|
|
| 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 | All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits. | Posted | Number | eyes | Summarized over all follow-up visits through one month | eyes | Participants |
|
|
|
| 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. | All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits. | Posted | Number | eyes | Summarized over all follow-up visits through 1 month | eyes | Participants |
|
|
|
| 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. | All Eligible, Dispensed Eyes, Over All Visits summarizes the worst case over the dispensing and all follow-up visits. | Posted | Number | eyes | Summarized over all follow-up visits through one month | eyes | Participants |
|
|
|
| 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. | All eligible dispensed eyes, summarized over all follow-up visits through 1 month. | Posted | Mean | Standard Deviation | units on a scale | Summarized over all follow-up visits through one month | eyes | Participants |
|
|
|
| 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 | All eligible, dispensed eyes | Posted | Mean | Standard Deviation | logMAR | 2 week and 1 month follow-up | eyes | Participants |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Marketed Daily Disposable Contact Lens | Marketed daily disposable cosmetic tint contact lens | 0 | 100 | 0 | 100 |
All study data generated as a result of this study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after the review by, and in consultation and agreement with the Sponsor,and such that confidential or proprietary information is not disclosed.
| Mild |
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| Moderate |
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| Severe |
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| Medium |
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| Heavy |
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| Fair |
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| Poor |
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| Insufficient |
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| Adherence |
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| End of Day Comfort |
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| Lens Awareness |
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| Lens Cleanliness |
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| Irritation |
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| Itching |
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| Dryness |
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| Redness |
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| Vision |
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| Lens Handling Upon Insertion |
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| Lens Handling Upon Removal |
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| Overall Impression |
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