Back to results

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

Primary Purpose

Dry Eye Syndromes

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Omega 3

Optive Advanced

Optive

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Eye drop 1

Eye drop 2

Eye drop 3

Arm Description

Omega 3

Optive Advanced

Optive

Outcomes

Primary Outcome Measures

Tear Evaporation Rate

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

Secondary Outcome Measures

Tear Break-up Time

Measured with fluorescein dye (seconds)

Subjective Ocular Comfort

Measured using visual analogue scales (0-100); 0 indicates no/less symptoms and 100 indicates maximum/worse symptoms.

Full Information

NCT ID

NCT02871440

First Posted

August 15, 2016

Last Updated

May 11, 2020

Sponsor

The University of New South Wales

Collaborators

Allergan

1. Study Identification

Unique Protocol Identification Number

NCT02871440

Brief Title

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

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

September 19, 2016 (Actual)

Primary Completion Date

September 18, 2017 (Actual)

Study Completion Date

September 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of New South Wales

Collaborators

Allergan

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Syndromes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Eye drop 1

Arm Type

Experimental

Arm Description

Omega 3

Arm Title

Eye drop 2

Arm Type

Active Comparator

Arm Description

Optive Advanced

Arm Title

Eye drop 3

Arm Type

Active Comparator

Arm Description

Optive

Intervention Type

Drug

Intervention Name(s)

Omega 3

Intervention Type

Drug

Intervention Name(s)

Optive Advanced

Intervention Type

Drug

Intervention Name(s)

Optive

Primary Outcome Measure Information:

Title

Tear Evaporation Rate

Description

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

Time Frame

Assessed at 4 weeks

Secondary Outcome Measure Information:

Title

Tear Break-up Time

Description

Measured with fluorescein dye (seconds)

Time Frame

Assessed at 4 weeks

Title

Subjective Ocular Comfort

Description

Measured using visual analogue scales (0-100); 0 indicates no/less symptoms and 100 indicates maximum/worse symptoms.

Time Frame

Assessed at 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fiona Stapleton, PhD

Organizational Affiliation

University of New South Wales

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs