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

NCT02980224 | Completed Phase 3 Results

• 1 other identifier: OmegaD-2016-001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 11

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 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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline and 84 Days

• 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.

  Baseline and 84 Days

Secondary Outcomes (1)

• The Frequency and Severity of Adverse Events

  84 Days

Study Arms (2)

OmegaD

EXPERIMENTAL

OmegaD Softgels

Drug: OmegaD

Placebo

PLACEBO COMPARATOR

Placebo Softgels

Drug: Placebo

Interventions

OmegaD DRUG

OmegaD Softgels

OmegaD

Placebo DRUG

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.
• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• OmegaD LLC: lead

Study Sites (11)

Unknown Facility

Artesia, California, United States

Location

Unknown Facility

Mission Hills, California, United States

Location

Unknown Facility

Rancho Cordova, California, United States

Location

Unknown Facility

Danbury, Connecticut, United States

Location

Unknown Facility

Crystal River, Florida, United States

Location

Unknown Facility

Deerfield Beach, Florida, United States

Location

Unknown Facility

Fort Myers, Florida, United States

Location

Unknown Facility

Pittsburg, Kansas, United States

Location

Unknown Facility

Edgewood, Kentucky, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

Unknown Facility

Cleveland, Ohio, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Jeremy Brace, President
• Organization: Brace Consulting Group Inc.

jbrace@braceconsultinggroup.com

7274582823

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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 30, 2016
• First Posted: December 2, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 13, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)