Study of ST-100 as Treatment for Dry Eye Disease

The objective of this study is to compare the safety and efficacy of two different concentrations of ST-100 Ophthalmic Solution to placebo (vehicle) for the treatment of the signs and symptoms of dry eye.

This is a Phase 2, multi-center, double-masked, randomized, placebo-controlled clinical study. Subjects will be randomized to one of the following treatment arms at Visit 2 (Day 1):

* Low dose ST-100 Ophthalmic Solution: 1 drop twice daily (BID) in each eye
* High dose ST-100 Ophthalmic Solution: 1 drop BID in each eye
* Placebo Ophthalmic Solution (Vehicle): 1 drop BID in each eye

Approximately 150 subjects will be randomly assigned to one of the three groups (1:1:1) to receive either ST-100 Ophthalmic Solution or placebo solution as topical ophthalmic drops administered bilaterally BID for 4 weeks. Subjects, Sponsor, Contract Research Organization (CRO), and site personnel will be masked to treatment assignment.

The clinical hypotheses for this study is that low dose and high dose ST-100 Ophthalmic Solution twice daily (BID) is superior to its vehicle (BID) for the primary endpoints of signs and symptoms of dry eye.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye;
* Have a history of use of eye drops for dry eye symptoms;
* Have symptoms of dry eye as determined by Ocular Discomfort \& 4-symptom questionnaire;
* Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm;
* Have conjunctival redness;
* Have corneal fluorescein staining;
* Have lissamine green conjunctival staining;
* Have signs and symptoms responses to Controlled Adverse Environment (CAE®);

Exclusion Criteria:

* Have any clinically significant slit lamp findings;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation ;
* Have worn contact lenses;
* Have used any eye drops;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery
* Have used Restasis, Xiidra, or Cequa ophthalmic solutions
* Have any planned ocular and/or lid surgeries or any ocular surgery;
* Have used, are using or anticipate using permanent or temporary punctal plugs during the study;
* Be currently taking any topical ophthalmic prescription;
* Be currently taking or have taken Omega-3 supplements;
* Be unable to read an eye chart;
* Be a woman who is pregnant, nursing, or planning a pregnancy;
* Be unwilling to submit a urine pregnancy test (or early termination visit) if of childbearing potential;
* Be a woman of childbearing potential who is not using an acceptable means of birth control;
* Have a known allergy and/or sensitivity to the test article or its components;
* Have a condition or be in a situation that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device;
* Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen;
* Have a known history of meibomian gland procedures (e.g., LipiFlow, LPI, probing, etc.);
* Be unable or unwilling to follow instructions, including participation in all study assessments and visits.