Phase 3
N=40
A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye
Dry Eye Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT02871440 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Tear Evaporation Rate — 77.7; 67; 75.3 g/m^2*h
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Omega 3 (Drug); Optive Advanced (Drug); Optive (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of New South Wales
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tear Evaporation Rate |
77.7; 67; 75.3 | — |
| SECONDARY Tear Break-up Time |
6.10; 6.52; 6.22 | — |
| SECONDARY Subjective Ocular Comfort |
21; 21; 21 | — |
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
Data sourced from ClinicalTrials.gov (NCT02871440). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.