Dry Eye DiseasePhase 2NCT05241470
Study of ST-100 as Treatment for Dry Eye Disease
A Phase 2 study testing ST-100 Ophthalmic Solution in people with Dry Eye Disease, run by Stuart Therapeutics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- ST-100 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 3 sitesUnited States
- Study dates
- 17 May 2021to 11 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Have conjunctival redness;
- Have corneal fluorescein staining;
- Have lissamine green conjunctival staining;
- Have signs and symptoms responses to Controlled Adverse Environment (CAE®);
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Andover Eye Associates - Raynham
Raynham, Massachusetts, 02767
About this study
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
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.
Read the 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
- Being tested
- ST-100 Ophthalmic Solution, Placebo Ophthalmic Solution
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST-100 Ophthalmic SolutionDrug
Also called ST-100
One drop in each eye twice a day
Placebo Ophthalmic SolutionDrug
Also called Vehicle
One drop in each eye twice a day
| Study group | Role | What they receive |
|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Active comparator | Low Dose ST100-001 Ophthalmic solution, 20mcg/ml Receives: Drug: ST-100 Ophthalmic Solution |
| High Dose ST-100 Ophthalmic Solution | Active comparator | High Dose ST100-001 Ophthalmic Solution, 50mcg/ml Receives: Drug: ST-100 Ophthalmic Solution |
| Placebo Ophthalmic Solution | Placebo comparator | Placebo Ophthalmic Solution (vehicle) Receives: Drug: Placebo Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Visit 2 (Day 1) to Visit 7 (Day 29)
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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®
Measured: 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®
Measured: 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.
Measured: Visit 6 (Day 15) Pre-CAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start17 May 2021
- Primary completion11 Oct 2021
- Study completion11 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stuart Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Robert O Baratta, MD, Study chair, Stuart Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05241470
- Sponsor's protocol ID
- ST100-001
- Status last verified
- Feb 2024
- First submitted
- 5 Jan 2022
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05241470
- Acronym / sponsor ID
- ST100-001
- Conditions
- Dry Eye Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Stuart Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 17 May 2021 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 11 Oct 2021 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Posted 13 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose ST-100 Ophthalmic Solution | Active comparator | Drug: ST-100 Ophthalmic SolutionLow Dose ST100-001 Ophthalmic solution, 20mcg/ml |
| High Dose ST-100 Ophthalmic Solution | Active comparator | Drug: ST-100 Ophthalmic SolutionHigh Dose ST100-001 Ophthalmic Solution, 50mcg/ml |
| Placebo Ophthalmic Solution | Placebo comparator | Drug: Placebo Ophthalmic SolutionPlacebo Ophthalmic Solution (vehicle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST-100 Ophthalmic SolutionAlso: ST-100One drop in each eye twice a day | Drug | High Dose ST-100 Ophthalmic Solution, Low Dose ST-100 Ophthalmic Solution |
| Placebo Ophthalmic SolutionAlso: VehicleOne drop in each eye twice a day | Drug | Placebo Ophthalmic Solution |
Primary outcome
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)
Time frame: Visit 2 (Day 1) to Visit 7 (Day 29)
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.
Change From Baseline of Ocular Discomfort in the Study Eye at Visit 7 (Day 29) Pre-CAE
Time frame: Visit 2 (Day 1) to Visit 7 (Day 29)
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.
5 secondary outcomes
Unanesthetized Schirmer's Responder Rate
Time frame: Visit 7 (Day 29), Pre-CAE
Change From Baseline of Best-Corrected Visual Acuity (ETDRS) - logMAR (Fellow Eye) at Visit 3 (Day 2)
Time frame: Visit 3 (Day 2)
Change From Baseline to Visit 4 (Day 4) in Ocular Surface Disease Index (Blurred Vision)
Time frame: Visit 4 (Day 4), Non-CAE
Change From Baseline to Visit 6 (Day 15) in Ocular Surface Disease Index (Pain)
Time frame: Visit 6 (Day 15) Pre-CAE
Change From Baseline in Ocular Discomfort Assessed by 4-Symptom Questionnaire
Time frame: Visit 6 (Day 15) Pre-CAE
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert O Baratta, MD study chair
Stuart Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ST-100 Ophthalmic Solution in people with Dry Eye Disease, run by Stuart Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Visit 2 (Day 1) to Visit 7 (Day 29)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.