Clinical trial NCT05241470: Study of ST-100 as Treatment for Dry Eye Disease
Official title: A Phase 2 Multi-Center, Randomized, Double Masked, Placebo Controlled Study to Assess the Safety and Efficacy of ST-100 Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Disease
Lead sponsor: Stuart Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2022-02-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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)
timeFrame: Visit 2 (Day 1) to Visit 7 (Day 29)
measure: Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE
timeFrame: Visit 2 (Day 1) to Visit 7 (Day 29)
Secondary outcomes:
measure: Unanesthetized Schirmer's Responder Rate
timeFrame: Visit 7 (Day 29), Pre-CAE
measure: Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2)
timeFrame: Visit 3 (Day 2)
measure: Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision)
timeFrame: Visit 4 (Day 4), Non-CAE
measure: Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain)
timeFrame: Visit 6 (Day 15) Pre-CAE
measure: Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire
timeFrame: Visit 6 (Day 15) Pre-CAE
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Raynham
country: United States
facility: Andover Eye Associates - Raynham
state: Massachusetts
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
Study officials:
affiliation: Stuart Therapeutics, Inc.
name: Robert O Baratta, MD
role: STUDY_CHAIR
References: