search
Back to results

Study of ST-100 as Treatment for Dry Eye Disease

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ST-100 Ophthalmic Solution
Placebo Ophthalmic Solution
Sponsored by
Stuart Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Andover Eye Associates
  • Andover Eye Associates - Raynham
  • Total Eye Care, P.A.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Low Dose ST-100 Ophthalmic Solution

High Dose ST-100 Ophthalmic Solution

Placebo Ophthalmic Solution

Arm Description

Low Dose ST100-001 Ophthalmic solution, 20mg/ml

High Dose ST100-001 Ophthalmic Solution, 50mg/ml

Placebo Ophthalmic Solution (vehicle)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fluorescein Staining
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
Lissamine Green Staining
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
Tear Film Break-up
Tear film break-up time at pre-CAE®, post- CAE®, and pre- to post-CAE®
Ora Calibra® Conjunctival Redness Scale
Ora Calibra® Conjunctival Redness 0-4 Scale where 4 is the worst at pre-CAE®, post- CAE®, and pre- to post-CAE®
Ora Calibra® Drop Comfort Scale
Ora Calibra® Drop Comfort 0-10 Scale where 10 is the worst
Ocular Surface Disease Index
Ocular Surface Disease Index (OSDI) 0-4 Scale where 4 is the worst at pre-CAE®
Four Symptom Questionnaire
Four symptom questionnaire rated on 0-5 scale where 5 is the worst at pre-CAE®, post-CAE®, and pre- to post-CAE®
Ora Calibra® Ocular Discomfort Scale
Ora Calibra® Ocular Discomfort 0-4 Scale where 4 is the worst during CAE® exposure.
Daily Diary
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.
Visual Analog Scale
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®
Schirmer's Test
Unanesthetized Schirmer's Test at pre-CAE®
Ora Calibra® Ocular Discomfort Scale
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®

Full Information

First Posted
January 5, 2022
Last Updated
February 22, 2022
Sponsor
Stuart Therapeutics, Inc.
Collaborators
ORA, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05241470
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
October 11, 2021 (Actual)
Study Completion Date
October 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stuart Therapeutics, Inc.
Collaborators
ORA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Dose ST-100 Ophthalmic Solution
Arm Type
Active Comparator
Arm Description
Low Dose ST100-001 Ophthalmic solution, 20mg/ml
Arm Title
High Dose ST-100 Ophthalmic Solution
Arm Type
Active Comparator
Arm Description
High Dose ST100-001 Ophthalmic Solution, 50mg/ml
Arm Title
Placebo Ophthalmic Solution
Arm Type
Placebo Comparator
Arm Description
Placebo Ophthalmic Solution (vehicle)
Intervention Type
Drug
Intervention Name(s)
ST-100 Ophthalmic Solution
Other Intervention Name(s)
ST-100
Intervention Description
One drop in each eye twice a day
Intervention Type
Drug
Intervention Name(s)
Placebo Ophthalmic Solution
Other Intervention Name(s)
Vehicle
Intervention Description
One drop in each eye twice a day
Primary Outcome Measure Information:
Title
Ora Calibra® Corneal Fluorescein Staining Scale
Description
Mean change on 5 corneal regions using 0-4 Ora Calibra® Fluorescein Staining Scale where 4 is the worst.
Time Frame
Visit 2 (Day 1) to Visit 7 (Day 29)
Title
Ora Calibra® Ocular Discomfort Scale
Description
Mean change using the 0-4 Ora Calibra® Ocular Discomfort Scale where 4 is the worst.
Time Frame
Visit 2 (Day 1) to Visit 7 (Day 29)
Secondary Outcome Measure Information:
Title
Fluorescein Staining
Description
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
Time Frame
Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)
Title
Lissamine Green Staining
Description
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
Time Frame
Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)
Title
Tear Film Break-up
Description
Tear film break-up time at pre-CAE®, post- CAE®, and pre- to post-CAE®
Time Frame
Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)
Title
Ora Calibra® Conjunctival Redness Scale
Description
Ora Calibra® Conjunctival Redness 0-4 Scale where 4 is the worst at pre-CAE®, post- CAE®, and pre- to post-CAE®
Time Frame
Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)
Title
Ora Calibra® Drop Comfort Scale
Description
Ora Calibra® Drop Comfort 0-10 Scale where 10 is the worst
Time Frame
Visit 2 (Day 1)
Title
Ocular Surface Disease Index
Description
Ocular Surface Disease Index (OSDI) 0-4 Scale where 4 is the worst at pre-CAE®
Time Frame
Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)
Title
Four Symptom Questionnaire
Description
Four symptom questionnaire rated on 0-5 scale where 5 is the worst at pre-CAE®, post-CAE®, and pre- to post-CAE®
Time Frame
Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)
Title
Ora Calibra® Ocular Discomfort Scale
Description
Ora Calibra® Ocular Discomfort 0-4 Scale where 4 is the worst during CAE® exposure.
Time Frame
Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)
Title
Daily Diary
Description
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.
Time Frame
Visit 2 (Day 1) to Visit 7 (Day 29)
Title
Visual Analog Scale
Description
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®
Time Frame
Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)
Title
Schirmer's Test
Description
Unanesthetized Schirmer's Test at pre-CAE®
Time Frame
Visit 7 (Day 29)
Title
Ora Calibra® Ocular Discomfort Scale
Description
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®
Time Frame
Visit 3 (Day 2), Visit 4 (Day 4), Visit 5 (Day 8), Visit 6 (Day 15), and Visit 7 (Day 29)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert O Baratta, MD
Organizational Affiliation
Stuart Therapeutics, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Andover Eye Associates
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Andover Eye Associates - Raynham
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
Total Eye Care, P.A.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of ST-100 as Treatment for Dry Eye Disease

We'll reach out to this number within 24 hrs