Safety and Efficacy of ST-100 (Vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution in Subjects Diagnosed With Dry Eye Disease (DED)

NCT06178679 | Unknown Phase 3 FDA Drug

• 1 other identifier: ST-100-002
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  15 days

• Assess the safety and tolerability of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution

  49 days

Other Outcomes (10)

• Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle using additional measures

  49 days

• Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle using additional measures

  49 days

• Compare the efficacy of ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Ophthalmic Solution to vehicle using additional measures

  49 days

Study Arms (2)

ST-100-002

EXPERIMENTAL

ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml Bilaterally twice daily for 7 weeks (49 days)

Drug: ST-100 (vezocolmitide)

Vehicle Ophthalmic Solution

PLACEBO COMPARATOR

Vehicle Ophthalmic Solution Bilaterally twice daily for 7 weeks (49 days)

Drug: Vehicle

Interventions

ST-100 (vezocolmitide) DRUG

ST-100 (vezocolmitide) Ophthalmic Solution 60 μg/ml

ST-100-002

Vehicle DRUG

Vehicle Ophthalmic Solution

Vehicle 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 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

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

Study Sites (1)

Total Eye Care, PA

Memphis, Tennessee, 38119, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 33882269 RESULT

• Fiscella RG. Understanding dry eye disease: a managed care perspective. Am J Manag Care. 2011 Dec;17 Suppl 16:S432-9.

  PMID: 22435675 RESULT

• Hapach 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.

  PMID: 26689380 RESULT

• Kivanany 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.

  PMID: 30248890 RESULT

• Messmer 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.

  PMID: 25686388 RESULT

• Ousler 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.

  PMID: 28956287 RESULT

• Shetty 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.

  PMID: 26890669 RESULT

• Wareham 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.

  PMID: 37260844 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Central Study Contacts

George Ousler

CONTACT

9786858900; gousler@oraclinical.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 21, 2023
• Study Start: December 29, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 30, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

US (1)