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

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.

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

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndromes
• Intervention / Treatment: Drug: Omega 3; Drug: Optive Advanced; Drug: Optive

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eye drop 1; Omega 3	Drug: Omega 3
Active Comparator: Eye drop 2; Optive Advanced	Drug: Optive Advanced
Active Comparator: Eye drop 3; Optive	Drug: Optive

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of New South Wales
• Collaborators: Allergan
• Investigators: Study Director: Fiona Stapleton, PhD, University of New South Wales

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Actual): September 18, 2017
• Study Completion (Actual): September 18, 2017

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: SOVS2016-040