Study of ST-100 as Treatment for Dry Eye Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: ST-100 Ophthalmic Solution; Drug: Placebo Ophthalmic Solution

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • Andover Eye Associates
    • Raynham, Massachusetts, United States, 02767
      • Andover Eye Associates - Raynham
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Total Eye Care, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Ophthalmic Solution; Placebo Ophthalmic Solution (vehicle)	Drug: Placebo Ophthalmic Solution; One drop in each eye twice a day; Other Names: Vehicle
Active Comparator: Low Dose ST-100 Ophthalmic Solution; Low Dose ST100-001 Ophthalmic solution, 20mcg/ml	Drug: ST-100 Ophthalmic Solution; One drop in each eye twice a day; Other Names: ST-100
Active Comparator: High Dose ST-100 Ophthalmic Solution; High Dose ST100-001 Ophthalmic Solution, 50mcg/ml	Drug: ST-100 Ophthalmic Solution; One drop in each eye twice a day; Other Names: ST-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	Visit 2 (Day 1) to Visit 7 (Day 29)
Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE	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.	Visit 2 (Day 1) to Visit 7 (Day 29)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unanesthetized Schirmer's Responder Rate	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.	Visit 7 (Day 29), Pre-CAE
Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at 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.	Visit 3 (Day 2)
Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision)	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®	Visit 4 (Day 4), Non-CAE
Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain)	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®	Visit 6 (Day 15) Pre-CAE
Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire	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.	Visit 6 (Day 15) Pre-CAE

Collaborators and Investigators

• Sponsor: Stuart Therapeutics, Inc.
• Collaborators: ORA, Inc.
• Investigators: Study Chair: Robert O Baratta, MD, Stuart Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): October 11, 2021
• Study Completion (Actual): October 11, 2021

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Pharmaceutical Solutions
• Other Study ID Numbers: ST100-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No