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

NCT ID: NCT02871440

Last Updated: 2020-05-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-19
• Study Completion Date: 2017-09-18

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

Conditions

Dry Eye Syndromes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Eye drop 1

Omega 3

Group Type: EXPERIMENTAL

Omega 3

Intervention Type: DRUG

Eye drop 2

Optive Advanced

Group Type: ACTIVE_COMPARATOR

Optive Advanced

Intervention Type: DRUG

Eye drop 3

Optive

Group Type: ACTIVE_COMPARATOR

Optive

Intervention Type: DRUG

Interventions

Omega 3

Intervention Type: DRUG

Optive Advanced

Intervention Type: DRUG

Optive

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: collaborator

The University of New South Wales

OTHER

Sponsor Role: lead

Responsible Party

Jacqueline Tan-Showyin

Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fiona Stapleton, PhD

Role: STUDY_DIRECTOR

University of New South Wales

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

SOVS2016-040

Identifier Type: -

Identifier Source: org_study_id