| Eligibility |
Inclusion Criteria:
General/Ocular Inclusion Criteria
1. Will be at least 18 years of age at the time of consent. 2. Able to provide written
voluntary informed consent. 3. Have a subject-reported history of DED in both eyes for at
least 6 months prior to Visit 1. 4. Have Tear film break-up time (TFBUT) =5 sec at Visit
- Have Ocular Surface Disease Index (OSDI) =25 at Visit 1.
- Have an unanesthetized Schirmer's Test I =5 mm at Visit 1.
- Have Meibomian Gland Dysfunction (MGD) defined as total MGD score = 3 (secretion of 5
central glands on lower eyelid will be evaluated, each will be scored from 0-3; 0 =
normal, 1 = thick/yellow, whitish, particulate 2 = paste; 3 = none/occluded; total
score will range from 0-15) at Visit 1.
- Have a total corneal fluorescein staining score of =2 and =11 (i.e. sum of inferior,
superior, central, nasal, and temporal) according to the National Eye Institute (NEI)
scale at Visit 1.
- Have at least one eye that satisfies all criteria for 4-8 above at Visit 1.
- Is able to fix his/her gaze for a minute, i.e. can see the fixation target and with no
nystagmus
- Is able and willing to follow instructions, including participation in all trial
assessments and visits.
Exclusion Criteria:
General/Ocular Exclusion Criteria
1. Have any clinically significant ocular surface slit-lamp findings at Visit 1 and Visit
2 and/or in the opinion of the Investigator had any findings that may have interfered
with trial parameters, including
1. history of eye trauma
2. history of Stevens-Johnson syndrome
3. active blepharitis or lid margin inflammation
4. DED secondary to scarring, irradiation, alkali burns, cicatricial pemphigoid, or
destruction of conjunctival goblet cells (as with vitamin A deficiency).
5. abnormal lid anatomy that caused incomplete eyelid closure
6. abnormal cornea shape (keratoconus)
7. corneal epithelial defect or significant confluent staining or filaments
8. history of herpetic keratitis.
9. has a pterygium in either eye.
10. ocular or periocular rosacea that in the judgement of the Investigator interfered
with the trial
2. Has used any topical ocular steroids treatments, prescription dry eye therapy
including varenicline nasal spray, or topical anti-glaucoma medication within 60 days
prior to Visit 1.
3. Have had a LipiFlow procedure, intense pulse light procedure or any kind of other
procedure affecting meibomian glands within 6 months prior to Visit 2.
4. Have received or removed a permanent punctum plug within 3 months (6 months for
dissolvable punctum plugs) prior to Visit 2.
5. Have used any eye drops (prescription or artificial tears) and/or TrueTearTM device
(intranasal tear neurostimulator) within 24 hours before Visit 2.
6. Have active ocular allergies or ocular allergies that are expected to be active during
the trial period.
7. Have worn contact lenses within 1 month of Visit 1 or anticipate using contact lenses
during the trial.
8. Have undergone intraocular surgery or ocular laser surgery within the previous 6
months or had any planned ocular and/or lid surgeries over the trial period.
9. Have an active ocular or systemic infection (bacterial, viral, or fungal), including
fever requiring treatment with antibiotics.
10. Is a woman who was pregnant, nursing or planning a pregnancy.
11. Is a woman of childbearing potential who is not using an acceptable means of birth
control; acceptable methods of contraception included: hormonal (oral, implantable,
injectable, or transdermal contraceptives); mechanical (spermicide in conjunction with
a barrier such as a diaphragm or condom); intrauterine device; or surgical
sterilization of partner. For non-sexually active females, abstinence could have been
regarded as an adequate method of birth control; however, if the subject becomes
sexually active during the trial, she must agree to use adequate birth control as
defined above for the remainder of the trial.
12. Has an uncontrolled systemic disease in the opinion of the Investigator will interfere
with the trial.
13. Has a known allergy and/or sensitivity to the investigational drug.
14. Has used any oral medications known to cause ocular drying (e.g., antihistamines,
antidepressants, etc.) on a non-stable regimen within 1 month prior to Visit 1 or is
expected to be unstable during the trial.
15. Have taken isotretinoin (e.g. Accutane, Myorisan, Claravis, Amnesteem) within 6 months
of Visit 1.
16. Has corrected VA worse than or equal to logarithm of the minimum angle of resolution
(LogMAR), +0.7 as assessed with Early Treatment Diabetic Retinopathy Study (ETDRS)
charts in both eyes at Visit 1.
17. Is currently enrolled in an investigational drug or device study or had used an
investigational drug or device within 60 days of Visit 2.
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