A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye

Study Overview
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Brief Summary
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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

Official Title
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A Two Comparator, Controlled Phase 3 Study of OM3 Tear Formulation Versus OPTIVE ADVANCED Unit Dose and OPTIVE Unit Dose Eye Drops in Patients With and Without Evaporative Dry Eye.

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Omega 3
* Drug: Optive Advanced
* Drug: Optive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eye drop 1<br>Omega 3 | Drug: Omega 3<br> <br> |
| Active Comparator: Eye drop 2<br>Optive Advanced | Drug: Optive Advanced<br> <br> |
| Active Comparator: Eye drop 3<br>Optive | Drug: Optive<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tear Evaporation Rate | Measured using a Vapometer (g/m^2*h) | Assessed at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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. | Assessed at 4 weeks |