Status:
COMPLETED
Study of ST-100 as Treatment for Dry Eye Disease
Lead Sponsor:
Stuart Therapeutics, Inc.
Collaborating Sponsors:
ORA, Inc.
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT05241470
Start Date
May 17 2021
End Date
October 11 2021
Last Update
March 13 2024
Active Locations (3)
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1
Andover Eye Associates
Andover, Massachusetts, United States, 01810
2
Andover Eye Associates - Raynham
Raynham, Massachusetts, United States, 02767
3
Total Eye Care, P.A.
Memphis, Tennessee, United States, 38119