CTRI/2022/03/041175进行中（未招募）4 期
A Phase IV Clinical Trial to Evaluate the Safety and Efficacy of SYSTANEHYDRATION in Indian Subjects with Dry Eye
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 177
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •1. Male or female adults aged >18 years and <65 years of age;
- •2. Subject must be willing to participate in the study and should understand and sign an informed consent form (ICF) that has been approved by Institutional Review Board (IRB)/ Institutional Ethics Committee (IEC);
- •3. BCVA of >=20/40 in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart;
- •4. DEQ-5 score >=6;
- •5. TBUT <=10 seconds in both eyes;
- •6. Average TOSS score >=4 (based on the 15-point Oxford grading scheme);
- •7. Subject is otherwise healthy and medically stable on the basis of medical history at screening (based on the investigatorâ??s medical
- •8. Male and female subjects of childbearing potential willing to practice appropriate birth control methods during the entire duration of the study. Appropriate birth control methods include
- •tubal ligation, transdermal contraceptive patch, intra uterine devices/systems, oral, implantable, or injectable contraceptives, sexual abstinence, double-barrier methods, and vasectomized partner.
排除标准
- •1. Women of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 1 year) are excluded from participating in the study if they meet any of the following conditions:
- •a. They are currently pregnant or planning to be pregnant during the study, or
- •b. They have a positive result on a urine pregnancy test (human chorionic gonadotropin) at the Screening Visit, or
- •c. They are breast feeding;
- •2. Contraindications or hypersensitivities to any of the components of the study treatment;
- •3. Evidence of the following within 30 days prior to the Screening Visit:
- •a. Ocular infection (bacterial, viral, or fungal)
- •b. Ocular inflammation including, but not limited to:
- •i. Inflammation of the anterior or posterior segments
- •ii. Active allergic conjunctivitis
- •iii. Active blepharitis or ocular rosacea;
- •4. Any history of:
- •a. Trachoma
- •b. Stevens-Johnson Syndrome
- •c. Ocular herpes simplex or herpes zoster;
- •5. Corneal conditions, other than dry eye-related corneal epitheliopathies, affecting the corneal structure including but not limited to:
- •a. Clinically significant epithelial or endothelial corneal dystrophies.
- •NOTE: Clinically significant corneal dystrophies are defined as those that affect the central corneal surface (central 5 mm zone) and are associated with the corneal erosion syndrome or
- •central corneal epithelial microcystic edema which will adversely affect BCVA. Any actively changing or unstable corneal condition; any corneal scar[s] affecting corneal clarity or structure of the cornea or demonstrate an area[s] of concentrated corneal staining.
- •b. Pterygia that extend >2 mm onto the corneal surface, or any ptyergia that are elevated rather than flat and/or demonstrating significant active inflammation
- •c. Keratoconus;
- •6. Ocular surgery (of any type, including photorefractive keratectomy, laser-assisted in situ keratomileusis, epipolis laser in situ keratomileusis [Epilasik], etc.) or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
- •7. Current presence of punctal plugs (permanent or temporary) or permanent punctal closure by cautery/diathermy are excluded except subjects who are free of punctual occlusion for at least 30 days prior to Screening;
- •8. Any corneal transplant procedure including penetrating keratoplasty, Descemetâ??s stripping endothelial keratoplasty, or its variants;
- •9. Suspected or definite lagophthalmos or history of Bellâ??s palsy (or other 7th cranial nerve [CN 7] palsy) or any other lid function abnormality (e.g., entropion, ectropion, floppy eyelid syndrome, trichiasis, etc.);
- •10. Use of any of topical ocular prescription or non-prescription medication, prior to 14 days of screening;
- •11. Systemic medications known to cause dry eye disease (such as anti-histamines, beta blockers, diuretics, anti-depressants, anti-psychotic medications, and benzodiazepines) which are
- •newly started or stopped or whose dose has been changed 30 days prior to Screening;
- •12. Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
- •13. Subjects with any prior history of artificial
- •tears/gels/lubricants/rewetting drops use in last 6 weeks;
- •14. Participation in any other clinical study (device
研究者
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