Study of ST-100 as Treatment for Dry Eye Disease

Phase 2

Completed

Conditions: Dry Eye Disease

Interventions: Drug: Placebo Ophthalmic Solution
Drug: ST-100 Ophthalmic Solution

Registration Number: NCT05241470

Lead Sponsor: Stuart Therapeutics, Inc.

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 eye.

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 Ophthalmic Solution: 1 drop twice daily (BID) in each eye

* High dose ST-100 Ophthalmic Solution: 1 drop BID in each eye

* Placebo Ophthalmic Solution (Vehicle): 1 drop BID in each eye

Approximately 150 subjects will be randomly assigned to one of the three groups (1:1:1) to receive either ST-100 Ophthalmic Solution or placebo solution as topical ophthalmic drops administered bilaterally BID for 4 weeks. Subjects, Sponsor, Contract Research Organization (CRO), and site personnel will be masked to treatment assignment.

The clinical hypotheses for this study is that low dose and high dose ST-100 Ophthalmic Solution twice daily (BID) is superior to its vehicle (BID) for the primary endpoints of signs and symptoms of dry eye.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Ophthalmic Solution	Placebo Ophthalmic Solution	Placebo Ophthalmic Solution (vehicle)
Low Dose ST-100 Ophthalmic Solution	ST-100 Ophthalmic Solution	Low Dose ST100-001 Ophthalmic solution, 20mcg/ml
High Dose ST-100 Ophthalmic Solution	ST-100 Ophthalmic Solution	High Dose ST100-001 Ophthalmic Solution, 50mcg/ml

Primary Outcome Measures

Name	Time	Method
Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE	Visit 2 (Day 1) to Visit 7 (Day 29)	Ocular Discomfort Scale is graded using the Ora Calibra Ocular Discomfort Scale (ODS). The scale ranges from 0 means no discomfort to 4 means worst discomfort. Higher score indicates more discomfort.
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)	Visit 2 (Day 1) to Visit 7 (Day 29)	The fluorescein staining is graded with the Ora Calibra® Corneal and Conjunctival Staining Scale. The scale is used to evaluate 3 corneal regions. Staining in each region is graded 0 to 4 where 0 means no staining, and 4 means worst staining. Higher score indicates more staining. The scoring reported ranges from 0-12. Mean change from baseline was calculated.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain)	Visit 6 (Day 15) Pre-CAE	Ocular Surface Disease Index (OSDI) Questions 3: Have you experienced painful or sore eyes during the last week? on 0-4 Scale where 4 is the worst at pre-CAE®
Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision)	Visit 4 (Day 4), Non-CAE	Ocular Surface Disease Index (OSDI) Questions 4: Have you experienced blurred vision during the last week? on 0-4 Scale where 4 is the worst at pre-CAE®
Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire	Visit 6 (Day 15) Pre-CAE	The Ora Calibra® Ocular Discomfort \& 4-Symptom Questionnaire is used, which includes rating of the severity of 5 symptoms: ocular discomfort, burning, dryness, grittiness, and stinging. Each symptom rating ranges from 0 to 5, where 0 = None and 5 = Worst. Higher score means worse symptom. Min score = 0, max score = 25.
Unanesthetized Schirmer's Responder Rate	Visit 7 (Day 29), Pre-CAE	The Schirmer's test strip is placed in the lower temporal lid margin of each eye. After 5 minutes, the test strip is removed and the length of the moistened area will be recorded in millimeters (mm) for each eye. The percentage of responders who had ≥ 10 mm increase from baseline in study eye in unanesthetized Schirmer's test was recorded.
Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2)	Visit 3 (Day 2)	LogMAR visual acuity (VA) is assessed using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The last line in which a letter is read correctly will be taken as the base logMAR reading. To this value will be added the number "N x 0.02" where 'N' represents the total number of letters missed up to and included in the last line read. This total sum represents the logMAR VA for that eye.

Trial Locations

Locations (3): Andover Eye Associates
🇺🇸
Andover, Massachusetts, United States
Andover Eye Associates - Raynham
🇺🇸
Raynham, Massachusetts, United States
Total Eye Care, P.A.
🇺🇸
Memphis, Tennessee, United States
Andover Eye Associates
🇺🇸Andover, Massachusetts, United States