Dry Eye DiseasePhase 3NCT06178679
Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease (DED)
A Phase 3 study testing ST-100 (vezocolmitide) in people with Dry Eye Disease, run by ORA, Inc. at 1 site in United States.
Trial summary
A Phase 3 Multi-Center, Randomized, Double Masked, Vehicle Controlled Study to Assess the Safety and Efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed with Dry Eye Disease (DED) 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 (vezocolmitide)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Dec 2023to 30 Jul 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 reported history of DED for at lease 6 months prior to Visit 1;
- Have a history of use or desire to use eye drops for DED within 6 months of Visit 1;
- Report a score of ≥ 2 on the Ora Calibra® Ocular Discomfort \& 4-symptom questionnaire in at least one symptom pre-CAE® at Visits 1 and 2;
- Have a Schirmer's Test score of ≤ 10 mm and ≥ 1 mm at Visits 1 and 2;
Show all 13Show fewer
- Have a conjunctival redness score ≥ 1 according to the Ora Calibra® Conjunctival Redness for Dry Eye Scale in at least one eye at pre-CAE® Visits 1 and 2;
- Have a corneal fluorescein staining score of ≥ 2 in at least one region (e.g. inferior, superior, or central) pre-CAE® at Visits 1 and 2;
- Have a sum corneal fluorescein staining score of ≥ 4, based on the sum of the inferior, superior, and central regions pre-CAE®, at Visits 1 and 2;
- Have a total lissamine green conjunctival score of ≥ 2, based on the sum of the temporal and nasal regions pre-CAE® at Visits 1 and 2;
- Demonstrates a response to the CAE® at Visits 1 and 2 as defined by:
- Having at least a ≥1 point increase in fluorescein staining in the inferior region in at least one eye following CAE® exposure Reporting an Ora Calibra® Ocular Discomfort Score ≥ 3 at 2 or more consecutive time points in at least one eye during CAE® exposure (if a subject has an ocular discomfort rating of 3 at a time = 0 for an eye, they must report an ocular discomfort rating of 4 for two consecutive measurements for that eye). Note: a subject cannot have an ocular discomfort score of 4 at time = 0);
- Have at lease one single eye satisfy all criteria for 6, 7, 8, 9, 10 and 11 above.
Who cannot join
- Have any clinically significant slit lap findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- 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 Tyrvaya® nasal spray, or Miebo® or Xdemvy® solution within 45 days of Visit 1;
Show all 22Show fewer
- 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 90 days of Visit 1;
- Be currently taking any topical ophthalmic prescription (including medications for glaucoma) or over-the-counter solutions, artificial tears, gels or scrubs, or using a moisture chamber and cannot discontinue these medications for the from Visit 1 until after Visit 8 of the trial (excluding medications allowed for the conduct of the study);
- Be currently taking or have taken Omega-3 supplements within the last 3 months;
- Be currently taking of have taken CHANTIX® (varenicline) tablets within 6 months prior to Visit 1 that is not on a stable dose. The dose cannot change during the conduct of the study;
- Have corrected visual acuity (VA) greater than or equal to logarithm of the Minimum Angle of Resolution (logMAR) +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit 1;
- Be a woman who is pregnant, nursing, or planning a pregnancy during the study;
- Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 8 (or early termination visit) if of childbearing potential. Non-childbearing potential is defined as a woman who is permanently sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy at least 6 months prior to dosing), or is post-menopausal (where post-menopausal is defined as no menses for 12 months without an alternative medial cause);
- Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception includes: hormonal - oral, implantable, injectable, or transdermal contraceptives for at least one month prior to first visit; Use two of the following effective methods of contraception: intrauterine device (IUD without local hormone release), diaphragm, cervical cap, and/or condoms; or surgical sterilization of partner (i.e., a female participant's male partner has undergone effective surgical sterilization such as vasectomy before the female participant entered the clinical trial) who has obtained documentation of absence of sperm in his ejaculate and is the sole sexual partner of the female participant during the clinical trial. For non-sexually active females, abstinence may be regarded as an adequate method of birth control; however, if the subject becomes sexually active during the study, she must agree to use adequate birth control as defined above for the remainder of the study;
- Have a known allergy and/or sensitivity to the Study Drug 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 the least 30 dats prior to Visit 1;
- Have a known history of meibomian gland procedures (e.g. LipiFlow, laser peripheral iridotomy (LPI), probing, etc.) within 6 months of study enrollment;
- Be unable or unwilling to follow instructions, including participation in all study assessments and visits;
- Has participated in any other clinical trials of ophthalmologic drugs for 30 days before or during participation in this Study.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Total Eye Care, PA
Memphis, Tennessee, 38119
David Evans, OD, 901-761-4620
David Evans, OD
About this study
Official title: A Phase 3 Multi-Center, Randomized, Double Masked, Vehicle Controlled Study to Assess the Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease (DED)
A Phase 3 Multi-Center, Randomized, Double Masked, Vehicle Controlled Study to Assess the Safety and Efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed with Dry Eye Disease (DED)
- Conditions
- Dry Eye Disease
- Being tested
- ST-100 (vezocolmitide), Vehicle
- 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 (vezocolmitide)Drug
ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml
VehicleDrug
Vehicle Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| ST-100-002 | Experimental | ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Bilaterally twice daily for 7 weeks (49 days) Receives: Drug: ST-100 (vezocolmitide) |
| Vehicle Ophthalmic Solution | Placebo comparator | Vehicle Ophthalmic Solution Bilaterally twice daily for 7 weeks (49 days) Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle using Schirmer's test at day 29
Proportion of responders in Schirmer's test with ≥ 10mm improvement from baseline at Day 29
Measured: 29 Days
Secondary outcomes (9)
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle for the treatment of the signs and symptoms of DED
Ocular Discomfort scores change from baseline at day 15 as measured by Ora Calibra Ocular Discomfort Scale
Measured: 15 Days
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle for the treatment of the signs and symptoms of DED
Pain Score change from baseline at Day 15
Measured: 15 Days
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle for the treatment of the signs and symptoms of DED
Blurred vision score change from baseline at day 4 as measured by OSDI
Measured: 4 days
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle for the treatment of the signs and symptoms of DED
Proportion of responders in Schirmer's Test with ≥ 10mm improvement from baseline at day 15
Measured: 15 days
Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution
Visual Acuity
Measured: 49 days
Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution
Slit-lamp evaluation
Measured: 49 days
Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution
Adverse event monitoring
Measured: 49 days
Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution
Intraocular pressure
Measured: 49 days
Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution
Undilated fundoscopy
Measured: 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start29 Dec 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ORA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stuart Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178679
- Sponsor's protocol ID
- ST-100-002
- Status last verified
- Jan 2024
- First submitted
- 7 Dec 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Baratta RO, Schlumpf E, Buono BJD, DeLorey S, Calkins DJ. Corneal collagen as a potential therapeutic target in dry eye disease. Surv Ophthalmol. 2022 Jan-Feb;67(1):60-67. doi: 10.1016/j.survophthal.2021.04.006. Epub 2021 Apr 18.
PubMed 33882269Fiscella RG. Understanding dry eye disease: a managed care perspective. Am J Manag Care. 2011 Dec;17 Suppl 16:S432-9.
PubMed 22435675Hapach LA, VanderBurgh JA, Miller JP, Reinhart-King CA. Manipulation of in vitro collagen matrix architecture for scaffolds of improved physiological relevance. Phys Biol. 2015 Dec 21;12(6):061002. doi: 10.1088/1478-3975/12/6/061002.
PubMed 26689380Kivanany PB, Grose KC, Yonet-Tanyeri N, Manohar S, Sunkara Y, Lam KH, Schmidtke DW, Varner VD, Petroll WM. An In Vitro Model for Assessing Corneal Keratocyte Spreading and Migration on Aligned Fibrillar Collagen. J Funct Biomater. 2018 Sep 21;9(4):54. doi: 10.3390/jfb9040054.
PubMed 30248890Messmer EM. The pathophysiology, diagnosis, and treatment of dry eye disease. Dtsch Arztebl Int. 2015 Jan 30;112(5):71-81; quiz 82. doi: 10.3238/arztebl.2015.0071.
PubMed 25686388Ousler GW 3rd, Rimmer D, Smith LM, Abelson MB. Use of the Controlled Adverse Environment (CAE) in Clinical Research: A Review. Ophthalmol Ther. 2017 Dec;6(2):263-276. doi: 10.1007/s40123-017-0110-x. Epub 2017 Sep 27.
PubMed 28956287Shetty R, Deshpande K, Deshmukh R, Jayadev C, Shroff R. Bowman Break and Subbasal Nerve Plexus Changes in a Patient With Dry Eye Presenting With Chronic Ocular Pain and Vitamin D Deficiency. Cornea. 2016 May;35(5):688-91. doi: 10.1097/ICO.0000000000000785.
PubMed 26890669Wareham LK, Holden JM, Bossardet OL, Baratta RO, Del Buono BJ, Schlumpf E, Calkins DJ. Collagen mimetic peptide repair of the corneal nerve bed in a mouse model of dry eye disease. Front Neurosci. 2023 May 16;17:1148950. doi: 10.3389/fnins.2023.1148950. eCollection 2023.
PubMed 37260844
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Multi-Center, Randomized, Double Masked, Vehicle Controlled Study to Assess the Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT06178679
- Acronym / sponsor ID
- ST-100-002
- Conditions
- Dry Eye Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- ORA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Stuart Therapeutics, Inc.
- Study start
- 29 Dec 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 21 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 3 Multi-Center, Randomized, Double Masked, Vehicle Controlled Study to Assess the Safety and Efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed with Dry Eye Disease (DED)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ST-100-002 | Experimental | Drug: ST-100 (vezocolmitide)ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Bilaterally twice daily for 7 weeks (49 days) |
| Vehicle Ophthalmic Solution | Placebo comparator | Drug: VehicleVehicle Ophthalmic Solution Bilaterally twice daily for 7 weeks (49 days) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Be at least 18 years of age;
- Provide written informed consent;
- Have a reported history of DED for at lease 6 months prior to Visit 1;
- Have a history of use or desire to use eye drops for DED within 6 months of Visit 1;
- Report a score of ≥ 2 on the Ora Calibra® Ocular Discomfort \& 4-symptom questionnaire in at least one symptom pre-CAE® at Visits 1 and 2;
Key exclusion criteria (22 listed)
- Have any clinically significant slit lap findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
- 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;
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 (vezocolmitide)ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml | Drug | ST-100-002 |
| VehicleVehicle Ophthalmic Solution | Drug | Vehicle Ophthalmic Solution |
Primary outcome
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle using Schirmer's test at day 29
Time frame: 29 Days
Proportion of responders in Schirmer's test with ≥ 10mm improvement from baseline at Day 29
9 secondary outcomes
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle for the treatment of the signs and symptoms of DED
Time frame: 15 Days
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle for the treatment of the signs and symptoms of DED
Time frame: 15 Days
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle for the treatment of the signs and symptoms of DED
Time frame: 4 days
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle for the treatment of the signs and symptoms of DED
Time frame: 15 days
Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution
Time frame: 49 days
Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution
Time frame: 49 days
Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution
Time frame: 49 days
Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution
Time frame: 49 days
Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution
Time frame: 49 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Results publication: PubMed 33882269Baratta RO, Schlumpf E, Buono BJD, DeLorey S, Calkins DJ. Corneal collagen as a potential therapeutic target in dry eye disease. Surv Ophthalmol. 2022 Jan-Feb;67(1):60-67. doi: 10.1016/j.survophthal.2021.04.006. Epub 2021 Apr 18.
- Results publication: PubMed 22435675Fiscella RG. Understanding dry eye disease: a managed care perspective. Am J Manag Care. 2011 Dec;17 Suppl 16:S432-9.
- Results publication: PubMed 26689380Hapach LA, VanderBurgh JA, Miller JP, Reinhart-King CA. Manipulation of in vitro collagen matrix architecture for scaffolds of improved physiological relevance. Phys Biol. 2015 Dec 21;12(6):061002. doi: 10.1088/1478-3975/12/6/061002.
- Results publication: PubMed 30248890Kivanany PB, Grose KC, Yonet-Tanyeri N, Manohar S, Sunkara Y, Lam KH, Schmidtke DW, Varner VD, Petroll WM. An In Vitro Model for Assessing Corneal Keratocyte Spreading and Migration on Aligned Fibrillar Collagen. J Funct Biomater. 2018 Sep 21;9(4):54. doi: 10.3390/jfb9040054.
- Results publication: PubMed 25686388Messmer EM. The pathophysiology, diagnosis, and treatment of dry eye disease. Dtsch Arztebl Int. 2015 Jan 30;112(5):71-81; quiz 82. doi: 10.3238/arztebl.2015.0071.
- Results publication: PubMed 28956287Ousler GW 3rd, Rimmer D, Smith LM, Abelson MB. Use of the Controlled Adverse Environment (CAE) in Clinical Research: A Review. Ophthalmol Ther. 2017 Dec;6(2):263-276. doi: 10.1007/s40123-017-0110-x. Epub 2017 Sep 27.
- Results publication: PubMed 26890669Shetty R, Deshpande K, Deshmukh R, Jayadev C, Shroff R. Bowman Break and Subbasal Nerve Plexus Changes in a Patient With Dry Eye Presenting With Chronic Ocular Pain and Vitamin D Deficiency. Cornea. 2016 May;35(5):688-91. doi: 10.1097/ICO.0000000000000785.
- Results publication: PubMed 37260844Wareham LK, Holden JM, Bossardet OL, Baratta RO, Del Buono BJ, Schlumpf E, Calkins DJ. Collagen mimetic peptide repair of the corneal nerve bed in a mouse model of dry eye disease. Front Neurosci. 2023 May 16;17:1148950. doi: 10.3389/fnins.2023.1148950. eCollection 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ST-100 (vezocolmitide) in people with Dry Eye Disease, run by ORA, Inc. at 1 site 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 13 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact George Ousler (9786858900 ext. 9481, gousler@oraclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle using Schirmer's test at day 29 (time frame: 29 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06178679, which also lists 8 linked publications.
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 18 Jan 2024.