Dry Eye
Conditions
Keywords
Dry eye, Tear film, Tear break-up time, Ocular surface, Eye drops
Brief summary
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.
Detailed description
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.
Interventions
OTHERFID 119515A
topical ocular drops
OTHERBlink® Tears
topical ocular drops
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Sign Informed Consent. * Best corrected visual acuity (BCVA) of 55 or greater in each eye as measured by an ETDRS chart (letters read method). * At least a 3 month documented history of dry eye in both eyes. * TBUT and Ocular Surface Disease Index (OSDI) Questionnaire score as specified in protocol. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Pregnant or breastfeeding. * Any evidence of ocular infection or inflammation within 30 days prior to Screening. * Any ocular surgery. * Ocular trauma requiring medical or pharmacological treatment within 1 year of Screening. * Current presence of punctal plugs (permanent or temporary) or previous permanent punctal closure by cautery/diathermy. * Use of topical ocular prescription or non-prescription medications within 30 days of Screening. * Participation in any other clinical trial within 30 days prior to Screening. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under Curve (AUC) of TBUT From 0 to 60 Minutes | 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. |
Participant flow
Recruitment details
Participants were recruited from 3 study centers located in the US.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| FID 119515A FID 119515A, 1 drop instilled in the study eye, single dose | 43 |
| Blink Blink® Tears, 1 drop instilled in the study eye, single dose | 19 |
| Total | 62 |
Baseline characteristics
| Characteristic | Blink | FID 119515A | Total |
|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 14.48 | 54.6 years STANDARD_DEVIATION 14.86 | 56.4 years STANDARD_DEVIATION 14.87 |
| Sex: Female, Male Female | 18 Participants | 32 Participants | 50 Participants |
| Sex: Female, Male Male | 1 Participants | 11 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 19 |
| serious Total, serious adverse events | 0 / 43 | 0 / 19 |
Outcome results
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.
Time frame: Baseline, 60 minutes
Population: This analysis population includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FID 119515A | Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes | 1.2 seconds | Standard Error 0.23 |
| Blink | Mean Change From Baseline in Tear Break-up Time (TBUT) at 60 Minutes | 1.2 seconds | Standard Error 0.22 |
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.
Time frame: 0 to 60 minutes
Population: This analysis population includes all randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FID 119515A | Area Under Curve (AUC) of TBUT From 0 to 60 Minutes | 4.5 seconds x hours | Standard Deviation 0.22 |
| Blink | Area Under Curve (AUC) of TBUT From 0 to 60 Minutes | 4.5 seconds x hours | Standard Deviation 0.21 |