ST266 Eyedrops for the Treatment of Persistent Corneal Epithelial Defects
NCT ID: NCT05066698
Last Updated: 2022-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2022-04-27
2022-09-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ST266
Topical ocular application: one drop in the study eye four times a day for 8 weeks
ST266
Topical ocular application: one drop four times a day for eight weeks
Open-label ST266
Open label extension for non-healers after completion of double-blind treatment phase: topical ocular application of one drop four times a day for eight weeks
Placebo
Topical ocular application: one drop in the study eye four times a day for 8 weeks
0.67% Sodium Chloride Ophthalmic Solution
Topical ocular application: one drop four times a day for eight weeks
Open-label ST266
Open label extension for non-healers after completion of double-blind treatment phase: topical ocular application of one drop four times a day for eight weeks
Interventions
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ST266
Topical ocular application: one drop four times a day for eight weeks
0.67% Sodium Chloride Ophthalmic Solution
Topical ocular application: one drop four times a day for eight weeks
Open-label ST266
Open label extension for non-healers after completion of double-blind treatment phase: topical ocular application of one drop four times a day for eight weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects with a PED present for at least seven (7) days at the time of Screening.
3. The defect must be at least 1.0 mm (longest linear measurement) at Screening and Baseline (Day 1) and must be measurable by slit lamp.
4. In the Investigator's opinion, the defect is persistent i.e., the defect has not shown improvement despite conventional treatment such as tear supplements and bandage contact lenses.
5. The original defect to the cornea must be the result of an injury, infection, disease, or surgery to the eye.
Exclusion Criteria
2. Subjects currently being treated with cenegermin or other rhNGF in the study eye.
3. Subjects currently using topical antibiotic eye drops in the study eye. Subjects on current antibiotic therapy must be willing to switch to study-provided moxifloxacin.
4. Subjects currently taking topical steroids or corticosteroid-containing eye drops or ointment in the study eye. Subjects currently taking systemic corticosteroids with a dose of \>10mg/day prednisone or equivalent.
5. Subjects currently using topical antihistamine eye drops or vasoconstrictors in the study eye.
6. Subjects currently using topical or local immunosuppressive agents (e.g., optic cyclosporine or lifitegrast) in the study eye.
7. Subjects who require treatment with autologous serum eyedrops or amnion products in the study eye.
8. Subjects who need to use contact lenses for refractive correction during the study.
9. Subjects who require treatment with bandage contact lens or punctal plugs in the study eye that cannot be removed.
10. Subjects currently taking antiviral medications for an active infection in the study eye. Subjects taking antiviral medications for prophylaxis may be enrolled in the study at the Investigator's discretion, provided that the subject remain on a stable dosing regimen throughout the duration of the study.
11. History of ocular surgery (including laser or refractive surgery) in the study eye within 1 month prior to study screening or, in the opinion of the Investigator, there are persistent post-surgical complications that would impact the study data.
12. Subjects with an uncontrolled lid or ocular infection in the study eye.
13. History of alkali burns of the cornea.
14. The circumference affected by limbal blood vessel ischemia is greater than 75 percent of the limbal circulation.
15. Subjects with severe lid abnormalities contributory to the persistence of the PED such as inability to close the lids.
16. Subjects who have a history of AIDS or HIV.
17. Subjects who have participated in a clinical trial (including a previous study involving ST266) within 30 days prior to Day 1.
18. Subjects who have more than one distinct PED in the study eye prior to screening visits. Subjects who develop PEDs after the screening visit will remain in the study; however, only the original study PED will be assessed.
19. For subjects with bilateral PEDs, only the eye with the larger PED should be entered into the study. The non-study eye will receive standard of care treatment and be observed throughout the trial.
20. Subjects with bullous keratopathy in the study eye.
21. Subjects with corneal perforation or impending corneal perforation in the study eye.
22. Subjects with uncontrolled glaucoma.
23. Female subjects who are pregnant or breastfeeding. Female subjects who are neither postmenopausal for at least 1 year nor surgically sterile require a negative urine pregnancy test. All subjects must use an acceptable form of birth control during the study such as abstinence, barrier method, or hormonal contraceptive.
24. Epithelial defect was classified as a progressive corneal melt caused by an immunological process such as rheumatoid melt or Mooren's ulceration.
25. Subjects with recurrent corneal erosion or corneal basement membrane dystrophy.
26. Known hypersensitivity to study provided lubricating drops, antibiotic drops, and/or procedural medications such as fluorescein dye.
27. Consideration by the Investigator, for any reason, that the subject is an unsuitable candidate to receive ST266.
18 Years
ALL
No
Sponsors
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IQVIA Biotech
INDUSTRY
Noveome Biotherapeutics, formerly Stemnion
INDUSTRY
Responsible Party
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Locations
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Trinity Research Group
Dothan, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Atlantis Eye Care
Huntington Beach, California, United States
UCLA Stein Eye Institute
Los Angeles, California, United States
Stanford
Palo Alto, California, United States
UCLA Doheny Eye Center
Pasadena, California, United States
California Eye Specialists Medical Group
Pasadena, California, United States
Bowden Eye & Associates
Jacksonville, Florida, United States
Shettle Eye Research
Largo, Florida, United States
Millennium Clinical Research, Inc
Miami, Florida, United States
MedEye Associates
Miami, Florida, United States
Cincinnati Eye Institute
Edgewood, Kentucky, United States
University of Maryland Eye Associates
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts Eye and Ear
Boston, Massachusetts, United States
Mercy Clinic Eye Specialists- Ophthalmology
Springfield, Missouri, United States
UNMC Truhlsen Eye Institute
Omaha, Nebraska, United States
UNC Kittner Eye Center
Chapel Hill, North Carolina, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
OSU Wexner Medical Center
Columbus, Ohio, United States
Ophthalmic Partners, PC
Bala-Cynwyd, Pennsylvania, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Houston Eye Associates
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Blanton Eye Institute/Houston Methodist Eye Associates
Houston, Texas, United States
Texas Eye Research Center
Hurst, Texas, United States
R and R Eye Research, LLC
San Antonio, Texas, United States
Piedmont Eye Center
Lynchburg, Virginia, United States
WVU Eye Institute
Morgantown, West Virginia, United States
The Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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Other Identifiers
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ST266-PED-202
Identifier Type: -
Identifier Source: org_study_id
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