Dry Eye Syndromes
Conditions
Brief summary
Omega 3 (OM3) Tear is a new unit dose emulsion, containing flaxseed/castor oil, which is being developed by Allergan. It is desirable to understand the effect that this new emulsion has on tear film evaporation and tear lipid profile via interferometry, in patients with evaporative dry eye (EDE) and those without (non-EDE). It would also be valuable to evaluate the retention time of the lipid components of the new emulsion via tear collection and analysis in EDE and non-EDE patients
Interventions
Sponsors
Allergan
The University of New South Wales
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to read and comprehend English and give informed consent as demonstrated by signing a record of informed consent; * Over 18 years of age; * Not wearing contact lenses in the past 3 months before enrolling * Willing to use eye drops and comply with the study visit schedule as directed by the Investigator; * Habitual (corrected or uncorrected) visual acuity of 6/9.5 or better in each eye; * At the Screening visit (Day -14), patients must have Ocular Surface Disease Index (OSDI) score \>18 (0 to 100 scale). At Baseline (Day 1) visits, patients must have OSDI score \> 12 to continue in the study. * TBUT≤10sec in at least 1 eye at Screening visit and Baseline visit * Corneal sodium fluorescein staining score ≥ 1 and \<4 (Oxford scheme) at Screening and Baseline visit.
Exclusion criteria
* Schirmer test (with anesthesia) ≤ 2 mm in either eye at Screening * Patients who are currently using topical ocular medication or have used topical ocular medication within 2 weeks of the Screening visit. Patients who are being treated bilaterally with a marketed artificial tear for dry eye can be considered, provided they discontinue use at the Screening visit; * Any active anterior segment disease excluding blepharitis; * Any systemic disease that may affect ocular health e.g. Graves disease, and auto-immune diseases such as ankylosing spondylitis, multiple sclerosis and systemic lupus erythematosus; * History of epilepsy or migraines exacerbated by flashing, strobe-like lights; * Rigid or soft contact lens wearer, including orthokeratology; * History of eye surgery within 6 months prior to enrolment in the study; * Previous corneal refractive surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tear Evaporation Rate | Assessed at 4 weeks | Measured using a Vapometer (g/m\^2\*h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Break-up Time | Assessed at 4 weeks | Measured with fluorescein dye (seconds) |
| Subjective Ocular Comfort | Assessed at 4 weeks | Measured using visual analogue scales (0-100); 0 indicates no/less symptoms and 100 indicates maximum/worse symptoms. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eye Drop 1 Omega 3 | 12 |
| Eye Drop 2 Optive Advanced | 13 |
| Eye Drop 3 Optive | 15 |
| Total | 40 |
Baseline characteristics
| Characteristic | Eye Drop 2 | Eye Drop 1 | Total | Eye Drop 3 |
|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 1 Participants | 2 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 1 Participants | 10 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 10 Participants | 28 Participants | 10 Participants |
| Age, Continuous | 40.26 years STANDARD_DEVIATION 20.84 | 39.98 years STANDARD_DEVIATION 20.07 | 40.49 years STANDARD_DEVIATION 20.26 | 40.91 years STANDARD_DEVIATION 20.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 11 Participants | 39 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Ocular Surface Disease Index | 34.00 units on a scale STANDARD_DEVIATION 14.34 | 35.28 units on a scale STANDARD_DEVIATION 16.26 | 35.28 units on a scale STANDARD_DEVIATION 16.14 | 34.47 units on a scale STANDARD_DEVIATION 15.67 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 8 Participants | 24 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 2 Participants | 14 Participants | 9 Participants |
| Region of Enrollment Australia | 13 participants | 12 participants | 40 participants | 15 participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 26 Participants | 9 Participants |
| Sex: Female, Male Male | 2 Participants | 6 Participants | 14 Participants | 6 Participants |
| Tear Break-Up Time | 6.52 seconds STANDARD_DEVIATION 2.95 | 6.14 seconds STANDARD_DEVIATION 2.73 | 6.14 seconds STANDARD_DEVIATION 2.73 | 6.22 seconds STANDARD_DEVIATION 2.74 |
| Tear Evaporation | 67 g/m^2*h STANDARD_DEVIATION 31.7 | 78.3 g/m^2*h STANDARD_DEVIATION 42.8 | 78.0 g/m^2*h STANDARD_DEVIATION 43.6 | 75.3 g/m^2*h STANDARD_DEVIATION 38 |
| Tear Volume | 13.83 mm STANDARD_DEVIATION 8.56 | 13.20 mm STANDARD_DEVIATION 9.06 | 13.83 mm STANDARD_DEVIATION 9.06 | 13.48 mm STANDARD_DEVIATION 8.93 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 13 | 0 / 15 |
| other Total, other adverse events | 3 / 12 | 4 / 13 | 1 / 15 |
| serious Total, serious adverse events | 0 / 12 | 0 / 13 | 0 / 15 |
Outcome results
Primary
Tear Evaporation Rate
Measured using a Vapometer (g/m\^2\*h)
Time frame: Assessed at 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eye Drop 1 | Tear Evaporation Rate | 77.7 g/m^2*h | Standard Deviation 42.4 |
| Eye Drop 2 | Tear Evaporation Rate | 67 g/m^2*h | Standard Deviation 31.7 |
| Eye Drop 3 | Tear Evaporation Rate | 75.3 g/m^2*h | Standard Deviation 38 |
Secondary
Subjective Ocular Comfort
Measured using visual analogue scales (0-100); 0 indicates no/less symptoms and 100 indicates maximum/worse symptoms.
Time frame: Assessed at 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eye Drop 1 | Subjective Ocular Comfort | 21 score on a scale | Standard Deviation 23.73 |
| Eye Drop 2 | Subjective Ocular Comfort | 21 score on a scale | Standard Deviation 23.89 |
| Eye Drop 3 | Subjective Ocular Comfort | 21 score on a scale | Standard Deviation 23.73 |
Secondary
Tear Break-up Time
Measured with fluorescein dye (seconds)
Time frame: Assessed at 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eye Drop 1 | Tear Break-up Time | 6.10 Seconds | Standard Deviation 2.76 |
| Eye Drop 2 | Tear Break-up Time | 6.52 Seconds | Standard Deviation 2.94 |
| Eye Drop 3 | Tear Break-up Time | 6.22 Seconds | Standard Deviation 2.73 |