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The purpose of this study was to compare the effect of FID 119515A to Blink® Tears on the integrity of tear film in adults with a history of dry eye in both eyes.
Subjects who met the enrollment criteria were randomized in a 2:1 manner to receive treatment with FID 119515A or Blink® Tears respectively for this 1-day, single-dose study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 119515A | Experimental | FID 119515A, 1 drop instilled in the study eye, single dose |
|
| Blink | Active Comparator | Blink® Tears, 1 drop instilled in the study eye, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 119515A | Other | topical ocular drops |
| |
| Blink® Tears |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes | Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used. | Baseline, 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) of TBUT From 0 to 60 Minutes | Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Lindsey, PhD | Alcon Research | Study Director |
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Of the 75 enrolled, 13 participants failed to meet inclusion/exclusion criteria and were exited as screen failures prior to randomization. This reporting group includes all enrolled and randomized participants (62).
Participants were recruited from 3 study centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | FID 119515A | FID 119515A, 1 drop instilled in the study eye, single dose |
| FG001 | Blink | Blink® Tears, 1 drop instilled in the study eye, single dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis group includes all randomized participants who received study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | FID 119515A | FID 119515A, 1 drop instilled in the study eye, single dose |
| BG001 | Blink | Blink® Tears, 1 drop instilled in the study eye, single dose |
| 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 Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes | Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used. | This analysis population includes all randomized participants. | Posted | Mean | Standard Error | seconds | Baseline, 60 minutes |
|
Adverse events (AEs) were collected for the duration of the study (1 month). AEs were obtained through solicited and spontaneous comments from the study subjects, and through observations by the study Investigator as outlined in the study protocol.
An AE was defined as any untoward medical occurrence in a subject who was administered a study medication, regardless of whether or not the event had a causal relationship with the medication. This analysis group includes all subjects who received study treatment.
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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 | FID 119515A | FID 119515A, 1 drop instilled in the study eye, single dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michela Montecchi-Palmer, Clinical Project Lead | Alcon Research, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Other |
topical ocular drops |
|
| 0 to 60 minutes |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Blink | Blink® Tears, 1 drop instilled in the study eye, single dose |
|
|
| Secondary | Area Under Curve (AUC) of TBUT From 0 to 60 Minutes | Fluorescein dye was instilled in the eye to assess tear break-up time. After instillation of the fluorescein, the subject was instructed to blink 3 times, then stare and not blink. The investigator measured the time from the last blink until the first black (dry) spot appeared in the precorneal tear film. Tear break-up time was assessed prior to test article instillation (baseline) and at 5, 15, 30, and 60 minutes. Three consecutive measurements were taken per eye at each time point, with the average of the 3 scores being the value analyzed. An increase in total score equates to improvement. One eye was chosen as the study eye and only data for the study eye were used. | This analysis population includes all randomized participants. | Posted | Mean | Standard Deviation | seconds x hours | 0 to 60 minutes |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Blink | Blink® Tears, 1 drop instilled in the study eye, single dose | 0 | 19 | 0 | 19 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.