Phase 2 Completed N=160 Randomized Quadruple-blind Treatment

Study of ST-100 as Treatment for Dry Eye Disease

Dry Eye Disease

Source: ClinicalTrials.gov NCT05241470 ↗

Enrolled (actual)

160

Serious AEs

0.9%

Results posted

Mar 2024

Primary outcomePrimary: Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE) — -0.17; -0.17; -0.18 units on a scale — p=0.9575

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline of Total Corneal Fluorescein Staining (Ora Calibra® Scale) in the Study Eye at Visit 7 (Day 29) Pre-Controlled Adverse Environment (Pre-CAE)	-0.17; -0.17; -0.18	0.9575
PRIMARY Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE	-0.3; -0.4; -0.3	0.5696
SECONDARY Unanesthetized Schirmer's Responder Rate	48; 49; 48	0.0266 sig
SECONDARY Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2)	-0.003; -0.028; 0013	0.0055 sig
SECONDARY Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision)	-0.1; -0.3; 0.2	0.0097 sig
SECONDARY Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain)	-0.1; -0.4; 0.0	0.0137 sig
SECONDARY Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire	-0.2; -0.4; 0.0	0.0332 sig

Eligibility 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;
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05241470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.