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| Name | Class |
|---|---|
| Bascom Palmer Eye Institute | OTHER |
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The purpose of this study was to compare the fit and comfort of two types of contact lenses.
The relationship between ocular comfort and the Optical Coherence Tomography (OCT) measurements of post lens clearance and ocular tissue compression was studied.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotrafilcon A test/lotrafilcon A control | Other | Lotrafilcon A test contact lens worn first, with lotrafilcon A control contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2. |
|
| Lotrafilcon A control/lotrafilcon A test | Other | Lotrafilcon A control contact lens worn first, with lotrafilcon A test contact lens worn second. Each product worn bilaterally for two days as follows: 20 minutes on Day 1 and 10 hours on Day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon A test contact lens | Device | Silicone hydrogel single vision, soft contact lens with alternate parameters |
|
| Measure | Description | Time Frame |
|---|---|---|
| Final Comfort | Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses"). | Day 2, Hour 10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jianhua Wang, MD, PhD | Bascom Palmer Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McKnight Building, Bascom Palmer Eye Institute | Miami | Florida | 33136 | United States |
This reporting group includes all enrolled participants.
Partipants were recruited from one US study center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lotrafilcon A Test, Then Lotrafilcon A Control | Lotrafilcon A test contact lenses worn in Period One, with lotrafilcon A control contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods. |
| FG001 | Lotrafilcon A Control, Then Lotrafilcon A Test | Lotrafilcon A control contact lenses worn in Period One, with lotrafilcon A test contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period One, 2 Days |
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| Period 2, 2 Days |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Each product worn bilaterally for two consecutive days in either Period One or Period Two. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods. |
| 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 Continuous | Mean |
| 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 | Final Comfort | Comfort was assessed by the participant on a Visual Analog Scale of 0 to 100, where 0=Extremely Uncomfortable ("My eyes are in pain. I cannot tolerate my lenses") and 100=Extremely Comfortable ("My eyes feel GREAT, better than normal. I cannot feel my lenses"). | All enrolled participants | Posted | Mean | Standard Deviation | Units on a scale | Day 2, Hour 10 |
|
Adverse events were collected for the duration of the study.
This reporting group includes all enrolled participants.
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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 | Lotrafilcon A Test | Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. |
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The sample size may be small for establishing relationship between ocular comfort and other measurable variables.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Clinical Trial Management | Alcon Research | 1-800-241-7629 |
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| Lotrafilcon A control contact lens | Device | Silicone hydrogel single vision, soft contact lens |
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| Ultra-High Resolution Optical Coherence Tomographer (OCT) | Device | Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Lotrafilcon A Control | Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. | 0 | 20 | 0 | 20 |
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