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

NCT02871440 | Completed Phase 3 Results

• 1 other identifier: SOVS2016-040
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Tear Evaporation Rate

  Measured using a Vapometer (g/m\^2\*h)

  Assessed at 4 weeks

Secondary Outcomes (2)

• Tear Break-up Time

  Assessed at 4 weeks

• Subjective Ocular Comfort

  Assessed at 4 weeks

Study Arms (3)

Eye drop 1

EXPERIMENTAL

Omega 3

Drug: Omega 3

Eye drop 2

ACTIVE COMPARATOR

Optive Advanced

Drug: Optive Advanced

Eye drop 3

ACTIVE COMPARATOR

Optive

Drug: Optive

Interventions

Omega 3 DRUG

Eye drop 1

Optive Advanced DRUG

Eye drop 2

Optive DRUG

Eye drop 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of New South Wales: lead
• Allergan: collaborator

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3; Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Dr Jacqueline Tan
• Organization: University of New South Wales

jacqueline.tan@unsw.edu.au

+61 (02) 9385 6551

Study Officials

• Fiona Stapleton, PhD

  University of New South Wales

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 18, 2016
• Study Start: September 19, 2016
• Primary Completion: September 18, 2017
• Study Completion: September 18, 2017
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-05