Clinical trial NCT02871440: A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Syndromes
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2016-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Tear Evaporation Rate
timeFrame: Assessed at 4 weeks
Secondary outcomes:
measure: Tear Break-up Time
timeFrame: Assessed at 4 weeks
measure: Subjective Ocular Comfort
timeFrame: Assessed at 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of New South Wales
name: Fiona Stapleton, PhD
role: STUDY_DIRECTOR
References: