Dry Eye SyndromeNCT01107964

Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome

A study testing Oral Omega-3-acid ethyl esters in people with Dry Eye Syndrome, run by Milton S. Hershey Medical Center at 1 site in United States.

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

The investigators hypothesize that oral omega-3-acid ethyl esters (Lovaza, GlaxoSmithKline, Research Triangle Park, NC) will decrease dry-eye related symptoms as well as clinical markers associated with dry eye disease (Schirmer-1 test values, positive vital staining with lissamine green, and fluorescein tear break-up… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Syndrome
What is being tested?: Oral Omega-3-acid ethyl esters
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: Jul 2010to 15 Jun 2015
Phase: Interventional
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

Age > 18 years
Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)
Schirmer Test < 8 mm/5 minutes
Fluorescein tear break-up time < 8 seconds
No current use of dry eye treatment (except artificial lubrication)
Signature on consent form

Who cannot join

Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye
Eyelid or eyelash abnormalities
Alteration of the nasolacrimal apparatus
Treatment with drugs affecting tearing
Concomitant ocular therapies
Topical ophthalmic steroids taken during the 4 weeks before the study

Show all 12Show fewer

Pregnant/breast-feeding women
History of liver disease
History of fish and/or shellfish allergy or hypersensitivity
History of corn allergy or hypersensitivity
Treatment with systemic anticoagulation therapy
Patients with bleeding disorders or those receiving anticoagulation (e.g., warfarin, enoxaparin, dipyridamole, clopidogrel)

Trial locations and contacts

1 site in 1 country.

United States1 site

Penn State Hershey Eye Center
Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Conditions: Dry Eye Syndrome
Being tested: Oral Omega-3-acid ethyl esters, Placebo corn oil capsule
Keywords: Dry Eye Syndrome, Recent Diagnosis of Dry Eye Syndrome
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.

Oral Omega-3-acid ethyl estersDrug
1 gram capsule by mouth four times daily for 45 days
Placebo corn oil capsuleDrug
1 gram by mouth 4 times daily for 45 days

Study groups in NCT01107964
Study group	Role	What they receive
Omega-3-acid ethyl esters	Active comparator	Not described Receives: Drug: Oral Omega-3-acid ethyl esters
Corn oil capsule	Placebo comparator	Not described Receives: Drug: Placebo corn oil capsule

What is being measured

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

Change From Baseline of the Ocular Surface Disease Index Score at Day 45
The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score)
Measured: Baseline and Day 45

Secondary outcomes (3)

Change From Baseline of Schirmer-1 Test Value at Day 45
Schirmer-1 Test Value is a measurement of tear production. The amount of tears are measured in total millimeters after 5 minutes has elapsed. Low levels of tear production are associated with dry eye. Change = (Day 45 value - Baseline value).
Measured: Baseline and Day 45
Change From Baseline of Lissamine Green Staining Score at Day 45
Lissamine Green Staining Score is a measure of ocular surface irregularity secondary to dry eye. Possible scores range from 0 (no ocular surface irregularity secondary to dry eye) to 9 (severe ocular surface irregularity secondary to dry eye). Change = (Day 45 score - Baseline score)
Measured: Baseline and Day 45
Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45
Fluorescein Tear Break-Up Time is a measurement in seconds of tear film stability. The shorter the Fluorescein Tear Break-Up Time, the lower the tear film stability.
Lower tear film stability is associated with dry eye. Change = (Day 45 value - Baseline value).
Measured: Baseline and Day 45

Timeline

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

Jul 201015 Jun 2015

First posted21 Apr 2010 (estimated)
Study startJul 2010
Primary completionAug 2014
Study completion15 Jun 2015

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 SyndromeStudies of the same condition, open and under way.
More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01107964
Sponsor's protocol ID: 33794
Status last verified: Nov 2017
First submitted: 20 Apr 2010
Last updated: 22 Dec 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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?

See locations

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All Dry Eye Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Oral Omega-3 Fatty Acids in the Treatment of Dry Eye Syndrome
ClinicalTrials.gov ID: NCT01107964
Acronym / sponsor ID: 33794
Conditions: Dry Eye Syndrome
Keywords: Dry Eye Syndrome, Recent Diagnosis of Dry Eye Syndrome
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: Milton S. Hershey Medical CenterUniversity, hospital or other
Collaborators: The American Society of Cataract and Refractive Surgery Foundation, GlaxoSmithKline
Study start: Jul 2010
Primary completion: Aug 2014 (actual)
Study completion: 15 Jun 2015 (actual)
First posted: 21 Apr 2010 (estimated)
Results: Posted 22 Dec 2017

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Omega-3-acid ethyl esters	Active comparator	Drug: Oral Omega-3-acid ethyl esters
Corn oil capsule	Placebo comparator	Drug: Placebo corn oil capsule

Who may qualify

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

Key inclusion criteria (6 listed)

Age > 18 years
Typical symptoms of dry eye (photophobia, burning, foreign body sensation, blurred vision improved with blinking)
Schirmer Test < 8 mm/5 minutes
Fluorescein tear break-up time < 8 seconds
No current use of dry eye treatment (except artificial lubrication)

Key exclusion criteria (12 listed)

Infectious keratoconjunctivitis or inflammatory disease unrelated to dry eye
Eyelid or eyelash abnormalities
Alteration of the nasolacrimal apparatus
Treatment with drugs affecting tearing
Concomitant ocular therapies

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
Oral Omega-3-acid ethyl esters1 gram capsule by mouth four times daily for 45 days	Drug	Omega-3-acid ethyl esters
Placebo corn oil capsule1 gram by mouth 4 times daily for 45 days	Drug	Corn oil capsule

Primary outcome

Change From Baseline of the Ocular Surface Disease Index Score at Day 45
Time frame: Baseline and Day 45
The Ocular Surface Disease Index Score is a validated, scored questionnaire that measures subjective symptoms of dry eye. Possible scores range from 0 (no symptoms of dry eye) to 100 (severest symptoms of dry eye). Change = (Day 45 score - Baseline score)

3 secondary outcomes

Change From Baseline of Schirmer-1 Test Value at Day 45
Time frame: Baseline and Day 45
Change From Baseline of Lissamine Green Staining Score at Day 45
Time frame: Baseline and Day 45
Change From Baseline of Fluorescein Tear Break-Up Time (Seconds) at Day 45
Time frame: Baseline and Day 45

Results and safety

Results posted to the registry on 22 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Omega-3-acid Ethyl Esters	13	12
Corn Oil Capsule	14	13

Primary outcome: Change From Baseline of the Ocular Surface Disease Index Score at Day 45

Time frame: Baseline and Day 45. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Omega-3-acid Ethyl Esters n = 12	Corn Oil Capsule n = 13
Value	-28.4 (-36.4 to -11.8)	-5.8 (-39.6 to 1.3)

Omega-3-acid Ethyl Esters vs Corn Oil Capsule: p = 0.61, Wilcoxon (Mann-Whitney)

Population analysed: Throughout the study, we evaluated the worse eye of each patient, defined as the eye with the the higher Lissamine Green Staining Score or the eye with the lower Schirmer-1 Test Value in the event of equality.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for the entire duration of the 45 day trial.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Omega-3-acid Ethyl Esters	0 of 13 (0%)	2 of 13 (15.4%)	0 of 13
Corn Oil Capsule	0 of 14 (0%)	1 of 14 (7.1%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
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Not yet recruitingPhase 2
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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.

David Liang, MD principal investigator

Milton S. Hershey Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Oral Omega-3-acid ethyl esters in people with Dry Eye Syndrome, run by Milton S. Hershey Medical Center at 1 site in United States.

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 6 inclusion and 12 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 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Dec 2017). 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?

Change From Baseline of the Ocular Surface Disease Index Score at Day 45 (time frame: Baseline and Day 45). 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 NCT01107964.

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 22 Dec 2017.