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Dry EyePhase 3NCT02980224

Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease

A Phase 3 study testing OmegaD in people with Dry Eye, run by OmegaD LLC at 11 sites 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

This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be compared to 2 placebo softgels dosed orally BID for 84 days. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Dry Eye
What is being tested?
OmegaD
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
180 participants
Where
11 sitesUnited States
Study dates
Oct 2016to Feb 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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects age ≥ 18 years and ≤ 90 years on the date of informed consent.
  • All subjects must provide signed written consent prior to participation in any study related procedures.
  • Patient-reported dry eye symptoms.
  • Clinical diagnosis of dry eye disease supported by global clinical assessment.
  • Presence of tear osmolarity in at least one eye ≥ 312 mOsm/L at both Screening and Baseline.
  • Presence of meibomian gland dysfunction as defined by a grade of 1 or 2 on the meibomian orifice size scale in at least one eye at both Screening and Baseline. The qualifying osmolarity level and meibomian orifice size grade must be present in the same eye at both Screening and Baseline if only one eye qualifies.
  • Female subjects of childbearing potential must have a negative urine pregnancy test at Screening. Women of childbearing potential (i.e., women who are not either postmenopausal for one year or surgically sterile) must use an acceptable form of contraception throughout the study.

Who cannot join

  • Allergy to fish oil or safflower oil (component of placebo softgels) or any component of the softgel material.
  • Schirmer's test score < 5 mm at Screening in either eye.
  • Tear break-up time > 7 seconds at Screening or Baseline in either eye.
  • Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeolum or chalazion.
  • Active seasonal and/or perennial allergic conjunctivitis or rhinitis.
  • Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for dry eye disease, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
Show all 20Show fewer
  • History or presence of abnormal nasolacrimal drainage.
  • Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) performed within one year prior to Screening and throughout the study period.
  • Ophthalmic drop use within 2 hours prior to any study visit. Any over-the-counter (OTC) artificial tear should be continued at the same frequency and with no change in drop brand.
  • Contact lens wear within 12 hours prior to any study visit; subjects determined to have worn contact lenses within 12 hours must be rescheduled.
  • Punctal cauterization or punctal plug placement within 60 days prior to Screening and throughout the study period.
  • Started or changed the dose of systemic medications known to affect tear production within 30 days prior to Screening and throughout the study period. These include but are not limited to the following medications:
  • Immunomodulators
  • Antihistamines
  • Tricyclic antidepressants
  • Diuretics
  • Corticosteroids (intranasal, inhaled, topical dermatological, and perianal steroids are permitted).
  • Use of any topical prescription ophthalmic medications (including cyclosporine [Restasis®, steroids, nonsteroidal anti-inflammatory drugs [NSAIDs], anti-glaucoma medications), oral tetracyclines or topical macrolides, oral nutraceuticals [fish, flax, black currant seed oils, etc.] within 21 days prior to Screening and throughout the study period.
  • Chronic daily use (defined as > 7 consecutive days at the recommended dosing frequency) of oral NSAIDs during the study period. ANY use of oral NSAIDS during the study period must be discussed with the Medical Monitor.
  • Participation in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Study site

    Artesia, California

  • Study site

    Cincinnati, Ohio

  • Study site

    Cleveland, Ohio

  • Study site

    Crystal River, Florida

  • Study site

    Danbury, Connecticut

  • Study site

    Deerfield Beach, Florida

  • Study site

    Edgewood, Kentucky

  • Study site

    Fort Myers, Florida

  • Study site

    Mission Hills, California

  • Study site

    Pittsburg, Kansas

  • Study site

    Rancho Cordova, California

Other trials in United States

About this study

Official title: A Randomized, Multicenter, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease

This is a phase 3 study to evaluate the safety and efficacy of OmegaD softgels for the treatment of dry eye disease. A daily dose of 2 OmegaD softgels dosed orally BID will be compared to 2 placebo softgels dosed orally BID for 84 days. Approximately 164 subjects will be evaluated for their signs and symptoms of dry eye disease and for safety throughout the study.

Read the detailed description

Inflammation is a key component of dry eye disease. Increasing the systemic levels of omega-3 fatty acids relative to omega-6 levels can mediate immune responses. Evaluating whether omega-3 supplementation can improve dry eye disease signs, symptoms and associated measures of inflammation may present a new therapeutic option for dry eye disease.

The primary objective of this study is to evaluate the safety and efficacy of twice daily (BID) dosing of OmegaD softgels in subjects with dry eye disease.

Male and female subjects between 18 years and 90 years of age, with patient-reported dry eye symptoms and a clinical diagnosis of dry eye disease supported by global clinical assessment will be screened and enrolled. Each subject must have, in at least one eye, tear osmolarity of ≥ 312 mOsm/L and meibomian gland dysfunction as defined by a grade of 1 or 2 on the meibomian orifice size scale at both Screening and Baseline in at least one eye. In addition, Tear break up time (TBUT) must be ≤ 7 seconds in both eyes at both Screening and Baseline and the Schirmer's test score in both eye(s) must be ≥ 5 mm at Baseline.

Approximately 164 subjects will be randomized (1:1) to 1 of 2 treatment arms and treated for 84 days (12 weeks) with either OmegaD softgels; 2 softgels BID or placebo softgels; 2 softgels BID. The study will be double-masked with OmegaD and placebo being identical-appearing softgels.

Subjects will participate in safety and efficacy assessments throughout the study. Efficacy assessments will include, tear osmolarity, meibomian gland dysfunction grading, TBUT, Schirmer's Test, and dry eye symptoms based on the OSDI questionnaire, Safety assessments will include, slit lamp examination and adverse events.

Conditions
Dry Eye
Being tested
OmegaD, Placebo
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.

  • OmegaDDrug

    OmegaD Softgels

  • PlaceboDrug

    Placebo Softgels

Study groups in NCT02980224
Study groupRoleWhat they receive
OmegaDExperimentalOmegaD Softgels
Receives: Drug: OmegaD
PlaceboPlacebo comparatorPlacebo Softgels
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline in Tear Break up Time(TBUT ) at Day 84

    The difference between Baseline (Day 1) and Day 84 in Tear Break Up Time. TBUT is a clinical test used to assess for evaporative dry eye disease. To measure TBUT, fluorescein is instilled into the patient's tear film and the patient is asked not to blink while the tear film is observed under a broad beam of cobalt blue illumination. The TBUT is recorded as the number of seconds that elapse between the last blink and the appearance of the first dry spot in the tear film, as observed via slit lamp examination.

    Measured: Baseline and 84 Days

  2. Change From Baseline in Dry Eye Symptom Scores (OSDI Questionnaire)

    Difference from Baseline (Day 1) to Day 84 in the OSDI Questionnaire (dry eye symptom score). Responses evaluate a subjects experience of a symptom on the following scale:

    0 (none of the time)

    1. (some of the time)
    2. (half of the time)
    3. (most of the time)
    4. (all of the time)

    The 12 questions are as follows:

    Have you experienced any of the following during the last week:

    1. Eyes that are sensitive to light
    2. Eyes that feel gritty
    3. Painful or sore eyes
    4. Blurred vision
    5. Poor vision Have problems with your eyes limited you in performance of any of the following during the last week:
    6. Reading
    7. Driving at night
    8. Working with a computer or bank machine (ATM)
    9. Watching TV Have your eyes felt uncomfortable in any of the following situations during the last week:
    10. Windy conditions
    11. Places or areas with low humidity (very dry)
    12. Areas that are air conditioned

    A higher score means a worse outcome. The scores for the 12 questions are added together.

    Measured: Baseline and 84 Days

Secondary outcomes (1)

  1. The Frequency and Severity of Adverse Events

    Number and Percentage of Subjects Reporting Adverse Events

    Measured: 84 Days

Timeline

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

  1. First posted2 Dec 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02980224
Sponsor's protocol ID
OmegaD-2016-001
Status last verified
Nov 2019
First submitted
30 Nov 2016
Last updated
13 Dec 2019
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing OmegaD in people with Dry Eye, run by OmegaD LLC at 11 sites 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 7 inclusion and 20 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 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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.

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 11 Sep 2019). 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 in Tear Break up Time(TBUT ) at Day 84 (time frame: Baseline and 84 Days). The study lists 2 primary outcomes in all. 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 NCT02980224.

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 13 Dec 2019.

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