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Study was terminated due to a business decision to cancel the entire project.
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to evaluate tears between habitual contact lens wearers and non contact lens wearers
The objective of this study is to evaluate tears between habitual contact lens wearers and non contact lens wearers using a Schirmer Strip for tear collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contact Lens Wear | Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution |
| |
| Non-Contact Lens Wear |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contact Lens Wear | Device | Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye. |
| Measure | Description | Time Frame |
|---|---|---|
| Hyaluronan Levels | Tear samples collected using a Schirmer tear strip and analyzed for hyaluronan (HA) levels, a lubricant found throughout the body, including tears. Levels will be compared between the lens wearers and non-lens wearers. | 7 days following lens insertion |
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Inclusion Criteria:
Exclusion Criteria:
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Specific characteristics are that one group will be habitual contact lens wearers, and the other group will be non-contact lens wearers (not having worn contact lenses within the last 7 days prior to baseline visit)
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| Name | Affiliation | Role |
|---|---|---|
| Robert Steffen, OD, MS | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | Rochester | New York | 14609 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Contact Lens Wear | Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye. Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye. |
| FG001 | Non-Contact Lens Wear | Non-Contact Lens Wear: No intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Contact Lens Wear | Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye. Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Hyaluronan Levels | Tear samples collected using a Schirmer tear strip and analyzed for hyaluronan (HA) levels, a lubricant found throughout the body, including tears. Levels will be compared between the lens wearers and non-lens wearers. | DUE TO THE CANCELLATION OF THIS PROJECT, NO STATISTICAL OR CLINICALLY MEANINGFUL CONCLUSIONS RELATED TO THE STUDY ENDPOINTS WERE MADE. | Posted | Mean | Standard Error | ng/mL | 7 days following lens insertion |
|
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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 | Contact Lens Wear | Senofilcon A Lenses, using Sensitive Eyes Saline Solution and/or Biotrue Multipurpose Solution Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye. Contact Lens Wear: Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Steffen, O.D., M.S. | Bausch & Lomb Incorporated | 585-338-6399 | Robert.Steffen@bausch.com |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D003262 | Contact Lenses, Extended-Wear |
| ID | Term |
|---|---|
| D003263 | Contact Lenses, Hydrophilic |
| D003261 | Contact Lenses |
| D007909 | Lenses |
| D055096 | Optical Devices |
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|
| Contact Lens Wear | Device | Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye. |
|
| Non-Contact Lens Wear | Other | No intervention |
|
| BG001 | Non-Contact Lens Wear | Non-Contact Lens Wear: No intervention |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Non-Contact Lens Wear | Non-Contact Lens Wear: No intervention |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Non-Contact Lens Wear | Non-Contact Lens Wear: No intervention | 0 | 13 | 0 | 13 |
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| D004864 |
| Equipment and Supplies |