Study of ST-100 as Treatment for Dry Eye Disease

• Status: Completed
• Trial end date: 2021-10-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stuart Therapeutics, Inc.
• Collaborator: ORA, Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

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;

• Ocular Discomfort & 4-symptom questionnaire;

• Schirmer's Test Score;

• Have conjunctival redness;

• Have corneal fluorescein staining;

• Have a sum corneal fluorescein staining score;

• Have a total lissamine green conjunctival score;

• Controlled Adverse Environment (CAE®);

Exclusion Criteria:

• Have any clinically significant slit lamp findings at Visit 1;

• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;

• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;

• Have used any eye drops within 2 hours of Visit 1;

• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;

• Have used Restasis, Xiidra, or Cequa ophthalmic solutions within 45 days of Visit 1;

• Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within the last 6 months;

• Have used, are using or anticipate using permanent or temporary punctal plugs during the study within 30 days of Visit 1;

• Be currently taking any topical ophthalmic prescription;

• Be currently taking or have taken Omega-3 supplements within the last 3 months;

• 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 at Visit 1 and Visit 5 (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 within 30 days of Visit 1;

• Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days prior to Visit 1;

• Have a known history of meibomian gland procedures (e.g., LipiFlow, LPI, probing, etc.) within 6 months of study enrollment;

• Be unable or unwilling to follow instructions, including participation in all study assessments and visits.