Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare AIR OPTIX® plus HydraGlyde (AOHG) contact lenses to ACUVUE® VITA® (VITA) contact lenses for total lipid uptake (total of surface and bulk uptake) after 30 days of wear by high lipid depositors.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lotrafilcon B, then senofilcon C | Other | Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution. |
|
| Senofilcon C, then lotrafilcon B | Other | Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses will be removed every night and cared for with the subject's habitual lens care solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lotrafilcon B contact lenses | Device | Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens | Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis. | Day 30 after 10 hours of wear, each product |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, Medical Clinical Trial Services | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | London | SW1E 6AU | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Of the 114 enrolled, 29 subjects were exited prior to randomization. An additional 4 subjects discontinued after randomization but prior to exposure. This reporting group includes all randomized and exposed subjects (81).
Subjects were recruited from 1 study center located in the United Kingdom.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AOHG Then VITA | Lotrafilcon B contact lenses worn first, followed by senofilcon C contact lenses, as randomized. Each product worn bilaterally (in both eyes) for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses were removed every night and cared for with the subject's habitual lens care solution. |
| FG001 | VITA Then AOHG | Senofilcon C contact lenses worn first, followed by lotrafilcon B contact lenses, as randomized. Each product worn bilaterally for a total duration of 30 (+ 3) days under a daily wear modality for the specific study period. The lenses were removed every night and cared for with the subject's habitual lens care solution. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1, First 30 Days of Wear |
|
| |||||||||||||||||||||
| Period 2, Second 30 Days of Wear |
|
This analysis population includes all randomized subjects who were exposed to AOHG or VITA lenses (Full Analysis Set).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Overall | Lotrafilcon B and senofilcon C contact lenses worn during Period 1 and Period 2 in a crossover assignment. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Mean Ex-vivo Total Lipid Uptake (Total of Surface and Bulk Uptake) Per Lens | Contact lens was removed aseptically from the eye. Total lipid (fatty deposits) uptake, defined as total amount of lipids (surface and bulk) absorbed/adsorbed and extracted, was measured in micrograms. A lower value indicates better results. Only one lens from each subject contributed to the analysis. | Full Analysis Set with non-missing response | Posted | Mean | Standard Deviation | micrograms (μg) | Day 30 after 10 hours of wear, each product |
|
Dispense through study completion, an average of 2.5 months
An adverse event (AE) was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users, or other persons, whether or not related to the study lenses. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AOHG | All subjects exposed to lotrafilcon B contact lenses | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CDMA Project Lead | Alcon Research | 1-888-451-3937 | alcon.medinfo@alcon.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 7, 2017 | May 7, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 3, 2018 | May 7, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Senofilcon C contact lenses | Device | Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking |
|
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Senofilcon C contact lenses worn bilaterally for 30 (+ 3) days under a daily wear modality. The lenses were removed every night and cared for with the subject's habitual lens care solution. |
|
|
|
| 76 |
| 0 |
| 76 |
| 0 |
| 76 |
| EG001 | VITA | All subjects exposed to senofilcon C contact lenses | 0 | 78 | 0 | 78 | 0 | 78 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.