Phase 3 Study of the Safety and Efficacy of OmegaD Softgels in the Treatment of Dry Eye Disease

NCT04181593 | Completed Phase 3 Results FDA Drug

• 1 other identifier: OmegaD-2019-002
• Study Type: interventional
• Target: 322
• Locations: 1 country
• Sites: 14

Brief 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. Approximately 300 subjects will be evaluated for their signs and symptoms of dry eye disease and for safety throughout the study.

Conditions

Dry Eye

Keywords

Dry Eye Disease; Ocular Surface Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  84 days

Secondary Outcomes (2)

• Tear Break Up Time (TBUT)

  84 days

• Schirmers Test

  84 days

Study Arms (2)

OmegaD

EXPERIMENTAL

OmegaD Softgels

Drug: Omega 3 fatty acid

Placebo

PLACEBO COMPARATOR

Placebo Softgels

Drug: Placebos

Interventions

Omega 3 fatty acid DRUG

Omega 3 fatty acid Softgels

Also known as: OmegaD Softgels

OmegaD

Placebos DRUG

Mineral oil Softgels

Also known as: Placebo Softgels

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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:

Sponsors & Collaborators

• OmegaD LLC: lead

Study Sites (14)

Eye Research Foundation

Newport Beach, California, 92663, United States

Location

Michael K Tran Inc

Westminster, California, 92683, United States

Location

Shettle Eye Research inc

Largo, Florida, 33773, United States

Location

Clayton Eye Clinical Research

Morrow, Georgia, 30260, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Heart of America Eye Care

Shawnee Mission, Kansas, 66204, United States

Location

Seidenberg Protzko Eye Associates

Havre de Grace, Maryland, 21078, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

West Bay Eye Associates

Warwick, Rhode Island, 02888, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Advancing Vision Research

Nashville, Tennessee, 37205, United States

Location

R and R Eye Research

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Fatty Acids, Omega-3

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fatty Acids, Unsaturated; Fatty Acids; Fish Oils; Oils

Results Point of Contact

• Title: Dr. Gregory Smith, MD
• Organization: OmegaD LLC

SGSmith@omegad.com

3023833948

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 29, 2019
• Study Start: November 18, 2019
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)