Study of ST-100 as Treatment for Dry Eye Disease

NCT05241470 | Completed Phase 2 Results FDA Drug

• 1 other identifier: ST100-001
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 3

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.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Unanesthetized Schirmer's Responder Rate

  Visit 7 (Day 29), Pre-CAE

• Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2)

  Visit 3 (Day 2)

• Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision)

  Visit 4 (Day 4), Non-CAE

• Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain)

  Visit 6 (Day 15) Pre-CAE

• Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire

  Visit 6 (Day 15) Pre-CAE

Study Arms (3)

Low Dose ST-100 Ophthalmic Solution

ACTIVE COMPARATOR

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

Drug: ST-100 Ophthalmic Solution

High Dose ST-100 Ophthalmic Solution

ACTIVE COMPARATOR

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

Drug: ST-100 Ophthalmic Solution

Placebo Ophthalmic Solution

PLACEBO COMPARATOR

Placebo Ophthalmic Solution (vehicle)

Drug: Placebo Ophthalmic Solution

Interventions

ST-100 Ophthalmic Solution DRUG

One drop in each eye twice a day

Also known as: ST-100

High Dose ST-100 Ophthalmic Solution; Low Dose ST-100 Ophthalmic Solution

Placebo Ophthalmic Solution DRUG

One drop in each eye twice a day

Also known as: Vehicle

Placebo Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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®);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Stuart Therapeutics, Inc.: lead
• ORA, Inc.: collaborator

Study Sites (3)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

Andover Eye Associates - Raynham

Raynham, Massachusetts, 02767, United States

Location

Total Eye Care, P.A.

Memphis, Tennessee, 38119, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Brian Del Buono, Executive Vice President
• Organization: Stuart Therapeutics

brian@stuarttherapeutics.com

7034025866

Study Officials

• Robert O Baratta, MD

  Stuart Therapeutics, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 15, 2022
• Study Start: May 17, 2021
• Primary Completion: October 11, 2021
• Study Completion: October 11, 2021
• Last Updated: March 13, 2024
• Results First Posted: March 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)