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
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the thickness of the pre-lens tear lipid layer after 2 hours of lens wear with use of FID 114657 compared to saline control.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 114657 | Experimental | FID 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. |
|
| Saline Control | Active Comparator | Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 114657 eye drops (10 ml) | Drug | Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1 | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure. | Day 1, after 2 hours of lens wear |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14 | At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. The participant rated both eyes together by providing one single rating. This outcome measure was prespecified for only FID 114657. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clinical Manager, Pharmaceuticals, Global Medical Affairs | Alcon Research | Study Director |
Not provided
Of the 234 enrolled, 84 participants were exited from the study as screen failures and 6 participants were discontinued prior to randomization. This reporting group includes all randomized and treated participants (Intent to Treat) (144).
A total of 234 participants were recruited from 6 investigational centers located in the United States.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Saline Control | Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. |
| FG001 | FID 114657 | Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants exposed to any test or control article evaluated in this study (Safety Analysis Set). Note: Two participants inadvertently received investigational product without being randomized, so are included in the safety analysis set only.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Saline Control | Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. |
| BG001 | FID 114657 |
| 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 Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 1 | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure. | Intention to treat participants with non-missing observations | Posted | Mean | Standard Deviation | ICU | Day 1, after 2 hours of lens wear |
|
Reporting of adverse events (AEs) began once informed consent was obtained from the participant, and continued through Day 14. This analysis population includes all participants exposed to any test or control article evaluated in this study.
An Adverse Event (AE) was any untoward medical occurrence in a participant who was administered a study treatment (i.e., initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. Solicited and spontaneous AE reports were collected for both eyes combined.
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 | Saline Control | Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Brand Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline control eye drops (15 ml) | Drug | Saline eye drops (15 ml) |
|
| Habitual contact lenses | Device | Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power |
|
| Baseline (Day 0), Day 14 |
| Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses | Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen. A 1-unit increase indicates improvement. The participant rated both eyes together by providing one single rating. | Baseline (Day 0), Day 14 |
| Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14 | At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. A positive change from Baseline indicates improvement. The participant rated both eyes together by providing one single rating. | Baseline (Day 0), Day 14 |
| Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14 | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure. | Day 14, after 2 hours of lens wear |
| Withdrawal by Subject |
|
Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | FID 114657 | Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. |
|
|
| Secondary | Mean Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) at Baseline and Day 14 | At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. The participant rated both eyes together by providing one single rating. This outcome measure was prespecified for only FID 114657. | Intention to treat participants with non-missing observations | Posted | Mean | Standard Deviation | hours | Baseline (Day 0), Day 14 |
|
|
|
| Secondary | Percentage of Participants That Experienced At Least 1 Unit Increase From Baseline Score to Day 14 for Overall Comfort With Lenses | Overall comfort was rated by the participant on a 10-point scale, where 1=Poor and 10=Excellent, at Day 0 for their habitual lenses and at Day 14 for the lenses worn for the study during use of the assigned drop regimen. A 1-unit increase indicates improvement. The participant rated both eyes together by providing one single rating. | Intention to treat participants with non-missing observations | Posted | Number | percentage of participants | Baseline (Day 0), Day 14 |
|
|
|
| Secondary | Mean Change From Baseline in Comfortable Lens Wear Time (Time Uncomfortable - Time Insertion) to Day 14 | At Baseline and on Day 14, comfort was collected through participant questionnaires regarding average and comfortable wear time. Participants filled in what time of day (over the past three days) they usually inserted their lenses, removed them, and at what time they usually became uncomfortable, or if they remained comfortable all day. Comfortable wear time was calculated as Time Uncomfortable minus Time Insertion. A positive change from Baseline indicates improvement. The participant rated both eyes together by providing one single rating. | Intention to treat participants with non-missing observations | Posted | Mean | Standard Deviation | hours | Baseline (Day 0), Day 14 |
|
|
|
| Secondary | Mean Pre-lens Tear Lipid Layer Thickness After 2 Hours of Lens Wear on Day 14 | The pre-lens tear film is the layer of tears located on top of the contact lens (i.e., between the eye lid and the contact lens). The anterior-most layer of the pre-lens tear film consists of lipids. Lipid layer thickness (LLT) is measured with the LipiView® Interferometer. LLT is measured in interferometric color units (ICUs), where 1 ICU reflects about 1 nanometer (nm) lipid layer thickness. Higher values of LLT indicate a better lubrication of the ocular surface. A thicker tear lipid layer helps reduce evaporation and is indicative of a more stable tear film. The right eye only was used for this measure. | Intention to treat participants with non-missing observations | Posted | Mean | Standard Deviation | ICU | Day 14, after 2 hours of lens wear |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | FID 114657 | Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks. | 0 | 72 | 0 | 72 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.