Study of ST-100 as Treatment for Dry Eye Disease

NCT ID: NCT05241470

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2021-10-11

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.

Conditions

Dry Eye Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Low Dose ST-100 Ophthalmic Solution

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

Group Type: ACTIVE_COMPARATOR

ST-100 Ophthalmic Solution

Intervention Type: DRUG

One drop in each eye twice a day

High Dose ST-100 Ophthalmic Solution

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

Group Type: ACTIVE_COMPARATOR

ST-100 Ophthalmic Solution

Intervention Type: DRUG

One drop in each eye twice a day

Placebo Ophthalmic Solution

Placebo Ophthalmic Solution (vehicle)

Group Type: PLACEBO_COMPARATOR

Placebo Ophthalmic Solution

Intervention Type: DRUG

One drop in each eye twice a day

Interventions

ST-100 Ophthalmic Solution

One drop in each eye twice a day

Intervention Type: DRUG

Placebo Ophthalmic Solution

One drop in each eye twice a day

Intervention Type: DRUG

Other Intervention Names

ST-100; Vehicle

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ORA, Inc.

INDUSTRY

Sponsor Role: collaborator

Stuart Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert O Baratta, MD

Role: STUDY_CHAIR

Stuart Therapeutics, Inc.

Locations

Andover Eye Associates

Andover, Massachusetts, United States

Andover Eye Associates - Raynham

Raynham, Massachusetts, United States

Total Eye Care, P.A.

Memphis, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ST100-001

Identifier Type: -

Identifier Source: org_study_id