Study of ST-100 as Treatment for Dry Eye Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye Disease

In brief

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.

Key facts

Study ID

NCT05241470

Run by

Stuart Therapeutics, Inc.

People needed

160

Starts

2021-05-17

Expected to finish

2021-10-11

Last updated by the study team

2024-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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®);

You may not qualify if…

• 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.

Where it is running

• Andover Eye Associates — Andover, Massachusetts, United States
• Andover Eye Associates - Raynham — Raynham, Massachusetts, United States
• Total Eye Care, P.A. — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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