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

ST100-001

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.

2021-05-17

2021-10-11

2021-10-11

Completed

Early phase I

160

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 160, 'type': 'ACTUAL'}}

2024-03-13