Study of ST-100 as Treatment for Dry Eye Disease

• Sponsor: Stuart Therapeutics, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05241470
• Collaborator: ORA, Inc. (Industry)
• Enrollment: 160
• Locations: 3
• Arms: 3
• Actual Duration (Months): 4.8
• Patients Per Site: 53.3
• Patients Per Site Per Month: 11

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: ST-100 Ophthalmic Solution; Drug: Placebo Ophthalmic Solution	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: May 17, 2021
• Actual Primary Completion Date: Oct 11, 2021
• Actual Study Completion Date: Oct 11, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ora Calibra® Corneal Fluorescein Staining Scale [Visit 2 (Day 1) to Visit 7 (Day 29)]

   Mean change on 5 corneal regions using 0-4 Ora Calibra® Fluorescein Staining Scale where 4 is the worst.

2. Ora Calibra® Ocular Discomfort Scale [Visit 2 (Day 1) to Visit 7 (Day 29)]

   Mean change using the 0-4 Ora Calibra® Ocular Discomfort Scale where 4 is the worst.

Secondary Outcome Measures

1. Fluorescein Staining [Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)]

   Fluorescein staining (Ora Calibra® scale) at pre-CAE®, post-CAE®, and pre- to post-CAE® regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score

2. Lissamine Green Staining [Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)]

   Lissamine green staining (Ora Calibra® scale) at pre-CAE®, post-CAE®, and pre- to post-CAE® regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score

3. Tear Film Break-up [Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)]

   Tear film break-up time at pre-CAE®, post- CAE®, and pre- to post-CAE®

4. Ora Calibra® Conjunctival Redness Scale [Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)]

   Ora Calibra® Conjunctival Redness 0-4 Scale where 4 is the worst at pre-CAE®, post- CAE®, and pre- to post-CAE®

5. Ora Calibra® Drop Comfort Scale [Visit 2 (Day 1)]

   Ora Calibra® Drop Comfort 0-10 Scale where 10 is the worst

6. Ocular Surface Disease Index [Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)]

   Ocular Surface Disease Index (OSDI) 0-4 Scale where 4 is the worst at pre-CAE®

7. Four Symptom Questionnaire [Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)]

   Four symptom questionnaire rated on 0-5 scale where 5 is the worst at pre-CAE®, post-CAE®, and pre- to post-CAE®

8. Ora Calibra® Ocular Discomfort Scale [Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)]

   Ora Calibra® Ocular Discomfort 0-4 Scale where 4 is the worst during CAE® exposure.

9. Daily Diary [Visit 2 (Day 1) to Visit 7 (Day 29)]

   Ora Calibra® Ocular Discomfort Scale & 4-Symptom Questionnaire is rating multiple symptoms (overall Ocular Discomfort plus Burning, Dryness, Grittiness, and Stinging) each on a 0-5 scale where 0 = none and 5 = worst.

10. Visual Analog Scale [Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)]

    Visual Analog Scale (VAS) rating Burning/Stinging, Itching, Foreign Body Sensation, Blurred Vision, Eye Dryness, Photophobia, Pain on 0-100% scale where 100% is the worst at pre-CAE®

11. Schirmer's Test [Visit 7 (Day 29)]

    Unanesthetized Schirmer's Test at pre-CAE®

12. Ora Calibra® Ocular Discomfort Scale [Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)]

    Ora Calibra® Ocular Discomfort 0-4 Scale where 4 is the worst outside of the CAE® at pre-CAE®, post-CAE®, and pre- to post-CAE®

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

• Ocular Discomfort & 4-symptom questionnaire;

• Schirmer's Test Score;

• Have conjunctival redness;

• Have corneal fluorescein staining;

• Have a sum corneal fluorescein staining score;

• Have a total lissamine green conjunctival score;

• Controlled Adverse Environment (CAE®);

Exclusion Criteria:

• Have any clinically significant slit lamp findings at Visit 1;

• Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;

• Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;

• Have used any eye drops within 2 hours of Visit 1;

• Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;

• Have used Restasis, Xiidra, or Cequa ophthalmic solutions within 45 days of Visit 1;

• Have any planned ocular and/or lid surgeries over the study period or any ocular surgery within the last 6 months;

• Have used, are using or anticipate using permanent or temporary punctal plugs during the study within 30 days of Visit 1;

• Be currently taking any topical ophthalmic prescription;

• Be currently taking or have taken Omega-3 supplements within the last 3 months;

• 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 at Visit 1 and Visit 5 (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 within 30 days of Visit 1;

• Be currently using any medication known to cause ocular drying that is not used on a stable dosing regimen for at least 30 days prior to Visit 1;

• Have a known history of meibomian gland procedures (e.g., LipiFlow, LPI, probing, etc.) within 6 months of study enrollment;

• Be unable or unwilling to follow instructions, including participation in all study assessments and visits.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

• Stuart Therapeutics, Inc.
• ORA, Inc.

Investigators

• Study Chair: Robert O Baratta, MD, Stuart Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stuart Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT05241470
• Other Study ID Numbers: ST100-001
• First Posted: Feb 15, 2022
• Last Update Posted: Mar 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Eye Diseases; Pharmaceutical Solutions; Ophthalmic Solutions

Study Results

No Results Posted as of Mar 10, 2022