ISRCTN15276264已完成未知
Multicentric, randomized, comparative clinical study on the evaluation of the efficacy and safety of Neovis® Total Multi versus Systane® Balance on the treatment of ocular dryness associated with meibomian gland dysfunction
Eurofins (France)0 个研究点目标入组 120 人开始时间: 2022年3月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Sex: male or female.
- •2. Age: 18 years and more.
- •3. Presenting dry eye symptoms for at least 6 months.
- •4. OSDI (Ocular Surface Disease Index) = 18
- •5. At least one eye eligible with:
- •5.1. sum of peripheral corneal and conjunctival staining = 4 and = 9 (Oxford 0-15 grading scheme) AND
- •5.2. sum of 3 measurements of Tear film Break-Up Time (TBUT) = 15s
- •6. Meibomian Gland Dysfunction on at least one eye (same eye eligible) with a score of 1 or higher for meibum quality score (from 0: clear to 3: toothpaste/obstruction) and evidence of partial or whole missing Meibomian Glands.
- •7. Ability and willingness to apply eyelid hygiene during the whole study, including wash-out period.
- •8. Having given freely and expressly his/her informed consent.
- •9. Able to comply with the study requirements, as defined in the present CIP, at the Investigator’s appreciation.
- •10. In France: subject being affiliated to a health social security system.
- •11. Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
排除标准
- •1. Pregnant or nursing woman or planning a pregnancy during the study.
- •2. Subject deprived of freedom by administrative or legal decision.
- •3. Subject in a social or health institution
- •4. Subject who is under guardianship or who is not able to express his/her consent.
- •5. Use of contact lenses in either eye during the study.
- •6. Far best-corrected visual acuity = 1/10.
- •7. Subject with severe ocular dryness with one of these conditions:
- •7.1. Eyelid or blinking malfunction
- •7.2. Corneal disorders not related to dry eye syndrome
- •7.3. Ocular metaplasia
- •7.4. Filamentous keratitis
- •7.5. Corneal neovascularization
- •8. History of ocular traumatism, ocular infection or ocular inflammation within the last 3 months.
- •9. History of ocular allergy or ocular herpes within the last 12 months.
- •10. Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months.
- •11. Any troubles of the ocular surface not related to dry eye syndrome.
- •12. Use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus during the month preceding the inclusion.
- •13. IOP > 21 mmHg
- •14. Uncontrolled systemic disease
- •15. Alcohol abuse
- •16. Psychiatric disorders
- •17. Cognitive impairment that could affect evaluation of preferences or inability to understand written patient information
- •18. Participation in other clinical studies in the last month
- •19. Hypersensitivity to one or more components of the study product
- •20. Dry eye due to systemic disease, concomitant medication, malign conditions or idiopathic causes
- •21. Punctual plugs during the past 3 months
- •22. Use of lipid-containing eye drops during the past 3 months
- •23. Use of other therapeutic ophthalmics during the past 3 months
- •24. Earlier participation at this clinical trial or the patient being an investigator or a member of the personnel involved at this clinical trial
研究者
相似试验
已完成
3 期
A multicentric, randomized, comparative clinical trial of Armodafinil versus Modafinil in patients with excessive sleepiness associated with shift work sleep disorder (SWSD).CTRI/2009/091/000617Emcure Pharmaceuticals Ltd Pune.
进行中（未招募）
不适用
Essai clinique, randomisé, multicentrique comparant l’efficacité et la tolérance d’un traitement prénatal par l’association pyriméthamine et sulfadiazine vs spiramycine pour réduire la transmission verticale de Toxoplasma gondii après primo-infection de la mère pendant la grossesse - TOXOGESTToxoplasmose acquise en cours de grossesse documentée par une seroconversionMedDRA version: 8.1Level: PTClassification code 10066653Term: Toxoplasmose prénataleEUCTR2010-019972-65-FRASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
进行中（未招募）
不适用
A randomised, comparative, multicentre clinical trial of the immunogenicity and safety of Tdap-IPV vaccine (REPEVAX) and a tetanus monovalent vaccine in healthy adults 18 years of age and olderAntibody responses to tetanus toxoid.MedDRA version: 9.1Level: LLTClassification code 10060308Term: Tetanus antibody positiveEUCTR2008-008724-32-DESanofi Pasteur MSD S.N.C.456
进行中（未招募）
1 期
A randomised, comparative, multicentre clinical trial of the immunogenicity and safety of Tdap-IPV vaccine (REPEVAX) and a tetanus monovalent vaccine in healthy adults 18 years of age and olderEUCTR2008-008724-32-FRSanofi Pasteur MSD S.N.C.
进行中（未招募）
1 期
ANTICIPUSC: Preoperative anticipation of respiratory risk according to ARISCAT scoring system and prophylactic post-operative non-invasive ventilation, comparing to standard post-operative care in patients at high-risk of respiratory complicationsEUCTR2017-001011-36-FRINSTITUT DE CANCEROLOGIE DE L'OUEST266