Study of ST-100 as Treatment for Dry Eye Disease

A Phase 2 Multi-Center, Randomized, Double Masked, Placebo Controlled Study to Assess the Safety and Efficacy of ST-100 Ophthalmic Solution in Subjects Diagnosed With 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.

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.