A Study to Assess the Effectiveness of Two Concentrations of STN1010904 Ophthalmic Suspension Compared with Inert vehicle in Participants diagnosed with Fuchs Endothelial Corneal Dystrophy (FECD)
- Conditions
- Health Condition 1: H184- Corneal degeneration
- Registration Number
- CTRI/2023/02/049356
- Lead Sponsor
- Santen Incorporated
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1) Male or female, from 30 to 75 years of age, diagnosed with FECD
2) Provide signed informed consent prior to any study procedures being performed
3) Best-corrected visual acuity (BCVA) of plus 0.2 LogMAR or better (equivalent to greater than or equal to 75 Early Treatment Diabetic Retinopathy Study [ETDRS] letters, or at least Snellen 20/32) in the study eye as measured using an ETDRS chart
4) Grade 3-5 of the Modified Krachmer scale in the study eye
5) At least two out of three tomographic features (Loss of parallel isopachs/ Displacement of the thinnest point of the cornea/ Focal posterior corneal depression) are observed by Pentacam, evaluated by the Investigator in the study eye
6) Endothelial cells are visible greater than 50 percent of area in at least one image obtained by noncontact specular microscopy in the central or paracentral-peripheral area in the study eye.
7) If a subject is a female of childbearing potential (that is, not post-menopausal [within 12 months since the last menses] or not surgically sterile [less than 6 months from date of surgery]), she must have a negative urine pregnancy test and must use at least one of the acceptable contraceptive methods during the study
8) The male partner of the female subject of childbearing potential should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study informed consent form (ICF) and beginning screening), or other contraception deemed adequate by the investigator during the study
9) Male subjects, with a female partner of childbearing potential, should use or practice an acceptable contraceptive method, such as abstinence, condom or vasectomy (surgery at least 6 months prior to signing the study ICF), or other contraception deemed adequate by the investigator during the study
10)Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
1) Monocular vision, or vision worse than plus 0.7 LogMAR (equivalent to less than 50 ETDRS letters, or worse than Snellen 20/100) in the fellow eye
2) No guttae in either eye (evaluated by slit lamp and specular microscope)
3) Clinically evident stromal and/or epithelial edema in the study eye (evaluated by slit lamp microscope)
4) Descemet folds in the study eye (evaluated by slit lamp microscope)
5) Central cornea thickness is 630μm or more in the study eye (evaluated by Scheimpflug image)
6) Moderate/severe cataract in the study eye (mild cataract or pseudophakic eye is eligible for enrolment)
7) Evidence of any other ocular disease other than FECD in the study eye that may confound the outcome of the study (example, active diabetic retinopathy, posterior uveitis, age-related macular degeneration or any other maculopathy, severe myopia greater than 10D, pterygium).
8) Any ocular surgery for FECD (e.g., penetrating keratoplasty (PKP), Descemet stripping endothelial keratoplasty (DSEK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping automated endothelial keratoplasty (DSAEK), Descemet stripping only (DSO) in the study eye
9) Cataract surgery or any kind of ocular surgery in the study eye within 6 months prior to Visit 1
10) Past history of filtering surgery for glaucoma in either eye (patients who underwent Minimally Invasive Glaucoma Surgery (MIGS) more than 6 months prior to Visit 1 are eligible for enrolment)
11) Laser treatment for glaucoma within 6 months prior to Visit 1 in the study eye
12) Need for ocular surgery or ocular laser treatment in either eye throughout the study
13) Media opacity that would affect contrast sensitivity in the study eye
14) Presence of any active inflammation, or infection of the eye and/or eyelids in either eye
15) History of herpetic infection in either eye or adnexa
16) Use of Rho-Associated kinase (ROCK) inhibitor eye drop in the study eye within 4 weeks prior to Visit 1 and during the course of the study
17) Use of CYP3A strong inhibitors during the course of the study
18) Use of topical Cyclosporin within 3 months prior to Visit 1 and during the course of the study
19) Use of Xiidra within 1 month prior to Visit 1 and during the course of the study
20) Allergy or hypersensitivity to study drug product, fluorescein dye, or other study related procedures/medications
21) Current or planned participation in any other clinical study involving an investigational product or device within 4 weeks prior to Visit 1 or at any time during this study
22) History of any disease or condition that in the opinion of the study investigator may put the subject at significant risk, may confound study results, or may interfere significantly with the subjectâ??s participation in the study
23) Immunosuppressive therapy (e.g., methotrexate, cyclosporine, cyclophosphamide, chlorambucil, mycophenolate mofetil, tacrolimus or azathioprine) other than prednisone or other corticosteroids within 4 weeks prior to Visit 1 or at any time during this study
24) Any recent systemic infection within 4 weeks prior to Visit 1
25) Known to be immunocompromised
26) History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindica
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method