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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Eye drop 1 | Experimental | Omega 3 |
|
| Eye drop 2 | Active Comparator | Optive Advanced |
|
| Eye drop 3 | Active Comparator | Optive |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omega 3 | Drug |
| ||
| Optive Advanced |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Evaporation Rate | Measured using a Vapometer (g/m^2*h) | Assessed at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Break-up Time | Measured with fluorescein dye (seconds) | Assessed at 4 weeks |
| Subjective Ocular Comfort | Measured using visual analogue scales (0-100); 0 indicates no/less symptoms and 100 indicates maximum/worse symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fiona Stapleton, PhD | University of New South Wales | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Eye Drop 1 | Omega 3 Tear Formulation (1-2 drops in each eye for at least 2 times daily) |
| FG001 | Eye Drop 2 | Optive Advanced (1-2 drops in each eye for at least 2 times daily) |
| FG002 | Eye Drop 3 | Optive (1-2 drops in each eye for at least 2 times daily) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Eye Drop 1 | Omega 3 |
| BG001 | Eye Drop 2 | Optive Advanced |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Tear Evaporation Rate | Measured using a Vapometer (g/m^2*h) | Posted | Mean | Standard Deviation | g/m^2*h | Assessed at 4 weeks |
|
4 weeks
All-cause mortality or serious adverse events were monitored/assessed. Since, total number of participants at risk will equal the number of participants started in the participant flow module, this section has been updated.
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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 | Eye Drop 1 | Omega 3 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacterial Chest Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Jacqueline Tan | University of New South Wales | +61 (02) 9385 6551 | jacqueline.tan@unsw.edu.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 14, 2016 | Aug 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
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|
| Optive | Drug |
|
| Assessed at 4 weeks |
| Eye Drop 3 |
Optive |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Ocular Surface Disease Index | Ocular Surface Disease Index has a score range of 0 to 100. Lower values indicate better outcomes. | Mean | Standard Deviation | units on a scale |
|
| Tear Evaporation | Mean | Standard Deviation | g/m^2*h |
|
| Tear Break-Up Time | Mean | Standard Deviation | seconds |
|
| Tear Volume | Schirmer's test is used to evaluate tear volume or tear production. Sterile paper strips are applied into the inferior-temporal aspect of the conjunctival sac of both eyes. The wetted length in millimeters is measures after 5 minutes. | Mean | Standard Deviation | mm |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Tear Break-up Time | Measured with fluorescein dye (seconds) | Posted | Mean | Standard Deviation | Seconds | Assessed at 4 weeks |
|
|
|
| Secondary | Subjective Ocular Comfort | Measured using visual analogue scales (0-100); 0 indicates no/less symptoms and 100 indicates maximum/worse symptoms. | Posted | Mean | Standard Deviation | score on a scale | Assessed at 4 weeks |
|
|
|
| 12 |
| 0 |
| 12 |
| 3 |
| 12 |
| EG001 | Eye Drop 2 | Optive Advanced | 0 | 13 | 0 | 13 | 4 | 13 |
| EG002 | Eye Drop 3 | Optive | 0 | 15 | 0 | 15 | 1 | 15 |
| Itchy and uncomfortable eyes | Eye disorders | Systematic Assessment |
|
| Burning and Stinging in the eye | Eye disorders | Systematic Assessment |
|
| Anemia and Vitamin D Deficiency | General disorders | Systematic Assessment |
|
| Ocular irritation | Eye disorders | Systematic Assessment |
|
| Lid Chalazion | Eye disorders | Systematic Assessment |
|
| Dry white residue around the eyes 5 min after using study drops | Eye disorders | Systematic Assessment |
|
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| D008055 |
| Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |