Dry Eye SyndromesPhase 3NCT02871440

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

A Phase 3 study testing Omega 3, Optive Advanced and Optive in people with Dry Eye Syndromes, run by The University of New South Wales.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndromes
What is being tested?: Omega 3, Optive Advanced and Optive
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: 19 Sep 2016to 18 Sep 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

About this study

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.

Conditions: Dry Eye Syndromes
Being tested: Omega 3, Optive Advanced, Optive
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omega 3Drug
Optive AdvancedDrug
OptiveDrug

Study groups in NCT02871440
Study group	Role	What they receive
Eye drop 1	Experimental	Omega 3 Receives: Drug: Omega 3
Eye drop 2	Active comparator	Optive Advanced Receives: Drug: Optive Advanced
Eye drop 3	Active comparator	Optive Receives: Drug: Optive

What is being measured

The primary outcome is the main question the study is designed to answer.

Tear Evaporation Rate
Measured using a Vapometer (g/m^2*h)
Measured: Assessed at 4 weeks

Secondary outcomes (2)

Tear Break-up Time
Measured with fluorescein dye (seconds)
Measured: 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.
Measured: Assessed at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Sep 201618 Sep 2017

First posted18 Aug 2016 (estimated)
Study start19 Sep 2016
Primary completion18 Sep 2017
Study completion18 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02871440
Sponsor's protocol ID: SOVS2016-040
Status last verified: May 2020
First submitted: 15 Aug 2016
Last updated: 12 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 2/3
A Clinical Study Evaluating Licaminlimab for Dry Eye Disease
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Characterization of Diseases With Salivary Gland Involvement
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UNITY DX Cornea Study
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Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
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Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes

All Dry Eye Syndromes trials

Study at a glance

From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02871440
Acronym / sponsor ID: SOVS2016-040
Conditions: Dry Eye Syndromes
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: The University of New South WalesUniversity, hospital or other
Collaborators: Allergan
Study start: 19 Sep 2016 (actual)
Primary completion: 18 Sep 2017 (actual)
Study completion: 18 Sep 2017 (actual)
First posted: 18 Aug 2016 (estimated)
Results: Posted 12 May 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Eye drop 1	Experimental	Drug: Omega 3Omega 3
Eye drop 2	Active comparator	Drug: Optive AdvancedOptive Advanced
Eye drop 3	Active comparator	Drug: OptiveOptive

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;

Key exclusion criteria (8 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omega 3	Drug	Eye drop 1
Optive Advanced	Drug	Eye drop 2
Optive	Drug	Eye drop 3

Primary outcome

Tear Evaporation Rate
Time frame: Assessed at 4 weeks
Measured using a Vapometer (g/m^2*h)

2 secondary outcomes

Tear Break-up Time
Time frame: Assessed at 4 weeks
Subjective Ocular Comfort
Time frame: Assessed at 4 weeks

Results and safety

Results posted to the registry on 12 May 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Eye Drop 1	12	12
Eye Drop 2	13	13
Eye Drop 3	15	15

Primary outcome: Tear Evaporation Rate

Time frame: Assessed at 4 weeks. Mean (Standard Deviation). Unit: g/m^2*h

Measure	Eye Drop 1 n = 12	Eye Drop 2 n = 13	Eye Drop 3 n = 15
Value	77.7 (42.4)	67 (31.7)	75.3 (38.0)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Eye Drop 1	0 of 12 (0%)	3 of 12 (25%)	0 of 12
Eye Drop 2	0 of 13 (0%)	4 of 13 (30.8%)	0 of 13
Eye Drop 3	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dry Eye Syndromes

Active, not recruitingPhase 2/3
A Clinical Study Evaluating Licaminlimab for Dry Eye Disease
Dry Eye Disease (DED)
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
RecruitingObservational study
UNITY DX Cornea Study
Tomography
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
Performance Evaluation of the OCUTOP Hand-held Corneal Topographer
Corneal Topography, Dry Eye Syndromes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fiona Stapleton, PhD study director

University of New South Wales

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omega 3, Optive Advanced and Optive in people with Dry Eye Syndromes, run by The University of New South Wales.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tear Evaporation Rate (time frame: Assessed at 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02871440.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.