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The objective of this study is to evaluate the performance of the PureVision Lens designs when worn on a 30-day continuous wear basis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Purevision Contact Lens #1 | Active Comparator | PureVision Soft Contact Lens Design (currently marketed) |
|
| PureVision Contact Lens #2 | Experimental | Redesign of the currently marketed PureVision soft contact lens. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Currently Marketed PureVision Contact Lens. | Device | Contact lens for continuous wear |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Responses to Symptoms/Complaints | Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint. | Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits |
| Measure | Description | Time Frame |
|---|---|---|
| LogMAR Visual Acuity | The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart. | Mean over all visits - 1 day, 1 week, 1 month |
| Lens Characteristics |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gerard Cairns, MCOptom, PhD | Bausch & Lomb Incorporated | Study Director |
| Benny Chian, MCOptom | Laser Focus Sdn Bhd, Vision Correction Centre | Principal Investigator |
| Harvey Siy Uy, MD | Asian Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser Focus Sdn Bhd, Vision Correction Centre | Johor Bahru | Johor Bahru | 80400 | Malaysia | ||
| Asian Eye Institute |
206 participants were enrolled. 204 participants were eligible and 189 completed the study. Study was a contralateral design with one eye of each patient randomly assigned to the experimental group and fellow eye to the control group.
Recruitment began on 12/24/07 and lasted for 1 month. Participants were recruited from 10 Asian Sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | PureVision Contact Lens | PureVision Contact Lens, Original Design and Alternate Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PureVision Contact Lens | PureVision Contact Lens Original Design and New Design. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean and standard deviation measured on the eligible population of 204 |
| 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 | Subjective Responses to Symptoms/Complaints | Subjective responses to symptoms/complaints on a scale 0-100, where 100 is the most favorable score. Subjects rated various aspects of lens comfort, vision, and handling. The average of each symptom/complaint over all follow-up visits was assessed as the primary endpoint. | All eligible participants | Posted | Mean | Standard Deviation | Visual Analogue Scale | Measured at screening/dispensing visit, 1 day, 1 week and 1 month follow-up visits | 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 | PureVision Contact Lens Design #1 | PureVision Contact Lens, Original Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye. |
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2 participants discontinued due to adverse events, not classified as serious. One subject in the test group developed corneal ulcer, one subject in the control group developed a central epithelial defect, both conditions resolved following treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Cairns | Bausch & Lomb Incorporated | (585)338 - 5170 | gerard.cairns@bausch.com |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Alternate Design of the PureVision Contact Lens. | Device | Contact lens for continuous wear |
|
Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement. |
| Over all scheduled visits day 1 - 1 month |
| Makati City |
| 1200 |
| Philippines |
| Physician Decision |
|
| Adverse Event |
|
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Gender was measured in the eligible population of 204 participants (408 eyes). | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
Redesign of the currently marketed PureVision soft contact lens.
|
|
| Secondary | LogMAR Visual Acuity | The mean distance high contrast LogMAR visual acuity (VA) score for test eyes over all visits, determined by the total number of letters correctly identified on the logMAR chart. | All Eligible, Dispensed Eyes | Posted | Mean | Standard Deviation | LogMAR | Mean over all visits - 1 day, 1 week, 1 month | eyes | Participants |
|
|
|
| Secondary | Lens Characteristics | Investigators evaluated study lenses, while on eye, for the number of eyes showing 100% wettability, no discoloration, none-light deposits, fully centered centration, and adequate movement. | Over All Scheduled Visits, All Eligible, Dispensed Eyes | Posted | Number | Eyes | Over all scheduled visits day 1 - 1 month | eyes | Participants |
|
|
|
| 0 |
| 204 |
| 0 |
| 204 |
| EG001 | PureVision Contact Lens Design #2 | PureVision Contact Lens Test Design. Subjects randomly assigned to receive the Purevision test lens in one eye and the marketed Purevision lens in the fellow eye | 0 | 204 | 0 | 204 |
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| Suboptimal lens deposits (medium/heavy) - absent |
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| Lens centration - excellent |
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| Lens movement - adequate |
|