Dry EyePhase 3NCT04181593
Phase 3 Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease
A Phase 3 study testing Omega 3 fatty acid in people with Dry Eye, run by OmegaD LLC at 14 sites in United States.
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 (mineral oil ) 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?
- Omega 3 fatty acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 14 sitesUnited States
- Study dates
- 18 Nov 2019to 28 Feb 2021
- 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.
- At least moderate ocular surface disease as measured by an OSDI score ≥ 20 at Screening.
- 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.
- Schirmer's test score (anesthetized) ≥ 5 mm in both eyes at Screening.
- TBUT ≤ 7 seconds in both eyes at Screening.
- 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.
Who cannot join
- Any previous reconstructive or cosmetic eyelid surgery that may, in the Investigator's opinion, affect the normal function of the lids (eg, blepharoplasty, ptosis repair, entropion/ectropion repair) that could affect study parameters/assessments.
- Cataract extraction, with or without minimally invasive glaucoma surgery (eg, iStent), within 90 days prior to Screening.
- Any previous invasive glaucoma surgery (eg, trabeculectomy, shunts, valves) and/or corneal surgery (eg, penetrating keratoplasty, lamellar keratoplasty, Descemet's stripping endothelial keratoplasty [DSEK]).
- Lid scrubs with over-the-counter (OTC) products (eg, OCuSOFT lid scrub, SteriLid, baby shampoo, etc.) and/or warm compresses within 14 days prior to Screening and throughout the study period.
- Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21 days prior to Screening and throughout the study period (systemic mast cell stabilizers are allowed, and systemic antihistamines are permitted with certain restrictions [see exclusion criterion 16]).
- Chronic daily use (defined as > 7 consecutive days at the recommended dosing frequency) of systemic narcotics for any chronic pain syndrome (eg, fibromyalgia, rheumatoid arthritis, etc.) during the study period. Short-term, as-needed dosing of a systemic narcotic for ≤ 72 hours is allowed, but not at Screening or on the day of the study visit.
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- Allergy to fish oil or mineral oil (component of placebo softgels) or any component of the softgel material.
- 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 or anticipated 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 or inflammation of the eye and ocular surface scarring.
- 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 artificial tear drop use within 2 hours prior to any study visit. Any OTC artificial tear (preserved or unpreserved) should be continued at the same frequency and with no change in drop brand.
- Contact lens wear within 12 hours prior to Screening or any study visit; subjects determined to have worn contact lenses within 12 hours must be rescheduled.
- History of cauterization of the punctum or existing silicone punctal plug(s); history of silicone plug removal or collagen plug insertion or removal within 12 months 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. Short-term, as-needed dosing of a systemic medication is allowed with certain restrictions. One 7-day course of systemic antihistamines is allowed, but not within 7 days of Screening or any other study visit. One short (≤ 72 hour) course of the other systemic medications that affect tear production is allowed but not within 30 days of Screening or on the day of any other study visit. These include, but are not limited to, the following medications:
- Immunomodulators
- Tricyclic antidepressants
- Diuretics
- Corticosteroids (intranasal, inhaled, topical dermatological, and perianal steroids are permitted)
- Use of any topical prescription ophthalmic medications (including cyclosporine [Restasis®, Cequa®] or topical lifitegrast [Xiidra®], steroids, nonsteroidal anti-inflammatory drugs [NSAIDs], anti-glaucoma medications, anti-microbials), topical macrolides, or oral nutraceuticals (fish, flax, black currant seed oils, etc.) within 21 days prior to Screening and throughout the study period.
- Use of oral tetracyclines or oral macrolides within 21 days prior to Screening and throughout the study period; use of isotretinoin (Accutane®) within 90 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. Aspirin of any dosage is permitted.
- Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control. Acceptable methods include the use of at least one of the following: intrauterine device (IUD), hormonal (oral, injection, patch, implant, ring), barrier with spermicide (condom, diaphragm), or abstinence. An adult woman is considered to be of childbearing potential unless she is 1 year postmenopausal or postsurgical hysterectomy. All women of childbearing potential, including those post-tubal ligation, must have a negative urine pregnancy test result at Visit 1 (Screening), Visit 2 (Baseline), and Visit 4 (Day 84) examinations and must intend to not become pregnant during the study.
- 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
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Abrams Eye Center
Cleveland, Ohio, 44115
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Silverstein Eye Centers
Kansas City, Missouri, 64133
Shettle Eye Research inc
Largo, Florida, 33773
Total Eye Care
Memphis, Tennessee, 38119
Clayton Eye Clinical Research
Morrow, Georgia, 30260
Advancing Vision Research
Nashville, Tennessee, 37205
Eye Research Foundation
Newport Beach, California, 92663
Kannarr Eye Care
Pittsburg, Kansas, 66762
R and R Eye Research
San Antonio, Texas, 78229
Heart of America Eye Care
Shawnee Mission, Kansas, 66204
Ophthalmology Associates
St Louis, Missouri, 63131
West Bay Eye Associates
Warwick, Rhode Island, 02888
Michael K Tran Inc
Westminster, California, 92683
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 (mineral oil ) dosed orally BID for 84 days. Approximately 300 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 at least moderate ocular surface disease (OSDI ≥ 20) 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 Screening and the Schirmer's test score in both eye(s) must be ≥ 5 mm at Screening.
Approximately 300 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
- Omega 3 fatty acid, Placebos
- Keywords
- Dry Eye Disease, Ocular Surface Disease
- 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 3 fatty acidDrug
Also called OmegaD Softgels
Omega 3 fatty acid Softgels
PlacebosDrug
Also called Placebo Softgels
Mineral oil Softgels
| Study group | Role | What they receive |
|---|---|---|
| OmegaD | Experimental | OmegaD Softgels Receives: Drug: Omega 3 fatty acid |
| Placebo | Placebo comparator | Placebo Softgels Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Osmolarity
Mean change from baseline in tear osmolarity to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. Lower values in tear osmolarity are considered to be better, therefore the larger the number for the change from baseline to Day 84 is considered to be better.
Measured: 84 days
Ocular Surface Disease Index (OSDI)
Mean change from baseline in OSDI to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. The OSDI is a patient reported outcome measured on a scale from 0 to 100 where higher scores represent greater disability. The overall score is calculated using a chart based on the sum of patient responses to 12 questions each rated on a scale from 0 to 4 where higher scores represent worse outcomes.
Measured: 84 days
Secondary outcomes (2)
Tear Break Up Time (TBUT)
Mean change from baseline in TBUT to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. TBUT is measured as the number of seconds the tear film takes to break up following administration of a drop of fluorescein dye to the eye. Longer times (higher values) represent better outcomes.
Measured: 84 days
Schirmers Test
Mean change from baseline in Schirmers Test to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. The test measures the distance in mm that tears travel along the Schirmer test strip (filter strip) after 5 minutes following the placement of the strip in the eye. Higher values represent better outcomes.
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start18 Nov 2019
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
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 EyeStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- OmegaD LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04181593
- Sponsor's protocol ID
- OmegaD-2019-002
- Status last verified
- Jul 2024
- First submitted
- 26 Nov 2019
- Last updated
- 29 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04181593
- Acronym / sponsor ID
- OmegaD-2019-002
- Conditions
- Dry Eye
- Keywords
- Dry Eye Disease, Ocular Surface Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- OmegaD LLCIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 29 Nov 2019 (actual)
- Results
- Posted 29 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (mineral oil ) dosed orally BID for 84 days. Approximately 300 subjects will be evaluated for their signs and symptoms of dry eye disease and for safety throughout the study.
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 at least moderate ocular surface disease (OSDI ≥ 20) 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 Screening and the Schirmer's test score in both eye(s) must be ≥ 5 mm at Screening.
Approximately 300 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.
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 |
|---|---|---|
| OmegaD | Experimental | Drug: Omega 3 fatty acidOmegaD Softgels |
| Placebo | Placebo comparator | Drug: PlacebosPlacebo Softgels |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- At least moderate ocular surface disease as measured by an OSDI score ≥ 20 at Screening.
- 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.
Key exclusion criteria (25 listed)
- Any previous reconstructive or cosmetic eyelid surgery that may, in the Investigator's opinion, affect the normal function of the lids (eg, blepharoplasty, ptosis repair, entropion/ectropion repair) that could affect study parameters/assessments.
- Cataract extraction, with or without minimally invasive glaucoma surgery (eg, iStent), within 90 days prior to Screening.
- Any previous invasive glaucoma surgery (eg, trabeculectomy, shunts, valves) and/or corneal surgery (eg, penetrating keratoplasty, lamellar keratoplasty, Descemet's stripping endothelial keratoplasty [DSEK]).
- Lid scrubs with over-the-counter (OTC) products (eg, OCuSOFT lid scrub, SteriLid, baby shampoo, etc.) and/or warm compresses within 14 days prior to Screening and throughout the study period.
- Prescription and OTC ophthalmic mast cell stabilizers and antihistamines within 21 days prior to Screening and throughout the study period (systemic mast cell stabilizers are allowed, and systemic antihistamines are permitted with certain restrictions [see exclusion criterion 16]).
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 fatty acidAlso: OmegaD SoftgelsOmega 3 fatty acid Softgels | Drug | OmegaD |
| PlacebosAlso: Placebo SoftgelsMineral oil Softgels | Drug | Placebo |
Primary outcome
Tear Osmolarity
Time frame: 84 days
Mean change from baseline in tear osmolarity to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. Lower values in tear osmolarity are considered to be better, therefore the larger the number for the change from baseline to Day 84 is considered to be better.
Ocular Surface Disease Index (OSDI)
Time frame: 84 days
Mean change from baseline in OSDI to Day 84 in the study eye. One eye (the designated study eye) was was analyzed for each participant. The OSDI is a patient reported outcome measured on a scale from 0 to 100 where higher scores represent greater disability. The overall score is calculated using a chart based on the sum of patient responses to 12 questions each rated on a scale from 0 to 4 where higher scores represent worse outcomes.
2 secondary outcomes
Tear Break Up Time (TBUT)
Time frame: 84 days
Schirmers Test
Time frame: 84 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega 3 fatty acid in people with Dry Eye, run by OmegaD LLC at 14 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 8 inclusion and 25 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 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 29 Jul 2024). 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 Osmolarity (time frame: 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?
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 29 Jul 2024.