| Eligibility |
Inclusion Criteria:
1. Subjects age = 18 years and = 90 years on the date of informed consent.
2. All subjects must provide signed written consent prior to participation in any
study-related procedures.
3. At least moderate ocular surface disease as measured by an OSDI score = 20 at
Screening.
4. Clinical diagnosis of dry eye disease supported by global clinical assessment.
5. Presence of tear osmolarity in at least one eye = 312 mOsm/L at both Screening and
Baseline.
6. Schirmer's test score (anesthetized) = 5 mm in both eyes at Screening.
7. TBUT = 7 seconds in both eyes at Screening.
8. 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.
Exclusion Criteria:
1. 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.
2. Cataract extraction, with or without minimally invasive glaucoma surgery (eg, iStent),
within 90 days prior to Screening.
3. Any previous invasive glaucoma surgery (eg, trabeculectomy, shunts, valves) and/or
corneal surgery (eg, penetrating keratoplasty, lamellar keratoplasty, Descemet's
stripping endothelial keratoplasty [DSEK]).
4. 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.
5. 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]).
6. 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.
7. Allergy to fish oil or mineral oil (component of placebo softgels) or any component of
the softgel material.
8. 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.
9. Active or anticipated seasonal and/or perennial allergic conjunctivitis or rhinitis.
10. 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.
11. History or presence of abnormal nasolacrimal drainage.
12. Laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK)
performed within one year prior to Screening and throughout the study period.
13. 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.
14. 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.
15. 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.
16. 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)
17. 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.
18. 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.
19. 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.
20. 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.
21. 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.
|
