CTRI/2023/02/049356尚未招募2 期
A Phase IIa, Randomized, Double-masked, Placebo-Controlled, Parallel-Group,Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared with Vehicle in Subjects with Fuchs Endothelial Corneal Dystrophy(FECD)– PHANTOM Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- 1. Change From Baseline in Best Corrected Visual Acuity (BCVA) with 100% Contrast Level
研究概览
简要总结
The main objective of this study is to assess the efficacy of two concentrations of STN1010904 ophthalmic suspension (0.03%, and 0.1 %), twice daily dosing when compared to Placebo in subjects diagnosed with
Fuchs Endothelial Corneal Dystrophy (FECD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, fixed
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
- •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.
排除标准
- •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).
- •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 subject’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 contraindicates the use of an investigational drug, might affect the interpretation of the results of the study, or renders the subject at high risk for treatment complications 27) History of ophthalmic malignancy 28) Malignancy in remission for less than 5 years prior to study participation 29) Females who are pregnant or lactating and females of child-bearing potential who are not willing to use acceptable contraceptive methods during the study and for 4 weeks following the last dose 30) Any decision by the Investigator or Medical Monitor to terminate a subject in screening or declare any subject ineligible for any sound medical reason.
结局指标
主要结局
1. Change From Baseline in Best Corrected Visual Acuity (BCVA) with 100% Contrast Level
时间窗: Baseline, Month 18
2. Change From Baseline in BCVA With 10 % Contrast Level
时间窗: Baseline, Month 18
3. Change From Baseline in Contrast Sensitivity With Glare Light
时间窗: Baseline, Month 18
次要结局
- Best Corrected Visual Acuity (BCVA) with Contrast Level of 100 Percent at All Post-baseline Visits(Up to month 18)
- Contrast Sensitivity with Glare Light at All Post-baseline(Visits)
- BCVA with Contrast Level of 10 Percent at All Post-baseline(visits)
- Change From Baseline in BCVA With 100 Percent Contrast Level at All Post-baseline(Visits)
- Contrast Sensitivity Without Glare Light at All Post-baseline(visits)
- Change From Baseline in Contrast Sensitivity Without Glare Light at All Post-Baseline visits(Up to month 18)
- Percent Change From Baseline in BCVA With 100 Percent Contrast Level at All Post-Baseline Visits(Up to month 18)
- Change From Baseline in BCVA With 10 Percent Contrast Level at All Post-baseline Visits(Up to month 18)
- Percent Change From Baseline in BCVA With 10 Percent Contrast Level at All Post-baseline Visits(Up to month 18)
- Change From Baseline in Contrast Sensitivity With Glare Light at All Post-baseline Visits(Up to month 18)
- Change From Baseline in Endothelial Cell Density at All Post-baseline(Visits)
- Percent Change From Baseline in Endothelial Cell Density at All Post-baseline(Visits)
- Percent Change From Baseline in Contrast Sensitivity With Glare Light at All Post-baseline Visits(Up to month 18)
- Percent Change From Baseline in Contrast Sensitivity Without Glare Light at All Post-baseline Visits(Up to month 18)
- Percent Change From Baseline in Central Corneal Thickness at All Post-baseline(Visits)
- Change From Baseline in Central Corneal Thickness at All Post-baseline(Visits)
- Change From Baseline in Guttae formation based on Modified Krachmer scale at All Post-baseline Visits(Up to month 18)
- Percent Change From Baseline in Guttae formation based on Modified Krachmer scale at All Post-baseline Visits(Up to month 18)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Phase 2a, Random, double masked, Placebo-controlled, side by side group, multiple center study evaluating the effectiveness and safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% compared with Placebo in Subjects with Fuchs endothelial Corneal Dystrophy (FECD) - PHANTOM Study2024-517104-11-00Santen Inc.15
已完成
2 期
A Multicenter Study Assessing the Efficacy and Safety of STN1010904 Ophthalmic Suspension 0.03% and 0.1% Compared With Vehicle in Subjects With Fuchs Endothelial Corneal Dystrophy (FECD)Fuchs Endothelial Corneal DystrophyNCT05376176Santen Inc.86
已完成
2 期
Study Assessing the Efficacy and Safety of STN1013600 Ophthalmic Solution 0.1% and 0.3% Compared With Placebo in Subjects With PresbyopiaPresbyopiaNCT05665387Santen Inc.79
招募中
3 期
A Study in Chinese Patients With Acquired BlepharoptosisBlepharoptosisNCT06683651Santen Pharmaceutical Co., Ltd.180
招募中
不适用
A Phase IIb study of STN1014100 ophthalmic solution in patients with dry eyeDry eyejRCT2031250105Santen pharmaceutical co.,ltd400