CTRI/2023/04/051870招募中4 期
A Multi-centric Post Marketing Surveillance Study (PMS Study) to Evaluate the Safety and Efficacy of SYSTANEâ?¢ Complete Lubricant Eye Drops in Indian Patients
Alcon Research Limited0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male or female adults aged >18 years of age
- •2. Patient must be willing to participate in the study and should understand and sign an ICF that has been approved by IRB/IEC;
- •3. Dry eye questionnaire 5 (DEQ-5) score > or equal to 6;
- •4. TBUT <10 and >5 seconds in both eyes;
- •5. Patient is otherwise healthy and medically stable on the basis of medical history at screening (based on the investigatorâ??s medical judgment);
- •6. Male and female patients 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.
- •7. Willing and able to make all required visits and follow study instructions
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 BCDVA. 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 patients 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. 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;
- •11. Unwillingness to discontinue contact lens wear at least one week prior to visit 1 and for the duration of the study;
- •12. Participation in any other clinical study (device or drug) within 30 days prior to Screening;
- •13. Any other condition that in the Investigatorâ??s judgment, might interfere with study assessments.
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