ISRCTN32614942进行中（未招募）1 期
Therapeutic fluid-gels for eye disease: Ocular Surface Disease. A phase I/IIa safety trial evaluating allogeneic donor serum gel in patients with severe ocular surface disease (OPtiCS-OSD)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
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. =16 years of age
- •2. Moderate to severe dry eye symptoms (Ocular surface disease index (OSDI) score =33)
- •3. Lubricant requirement = 2 hourly
- •4. Stable on their current Serum Eye Drop (SED) therapy for >3 months (defined as no need for acute intervention in preceding 3 months) or have previously used SED as part of their ocular therapy
排除标准
- •For Stages 1 and 2:
- •1. Unwilling to stop wearing contact lenses for the duration of the trial
- •2. Active seasonal allergic conjunctivitis (hay fever)
- •3. Presence of active ophthalmic infection: bacterial, fungal or viral
- •4. Presence of persistent infective corneal ulcers or current eye condition impacting on the trial as judged by a clinician
- •5. Known hypersensitivity to any of the components of the trial or procedural medication
- •6. History of drug, medication or alcohol abuse or addiction
- •7. Unable to understand, speak and write the English language
- •8. Vision insufficient to be able to do all the assessments as judged by the participant
- •9. Use of any investigational agent within 4 weeks of trial entry
- •10. Participation in another investigational medicinal product (IMP) or ophthalmic interventional clinical trial at the same time as the present trial
- •11. Participant has received a live attenuated vaccine within 30 days of trial entry
- •12. Participants on an unstable dose of antidepressants or not willing to stay on the same dose throughout the trial duration
- •13. Participants on an unstable standard daily dose of inhaled steroids or not willing to stay on the same dose throughout the trial duration PRN may differ but the standard daily dose prescribed must not vary).
- •14. Participants who are not willing or able to adhere to trial procedures and/or schedule
- •15. Participants with evidence of significant acute or chronic medical or psychiatric condition that, in the judgement of the investigator, would compromise the participant’s safety or ability to complete the trial.
- •16. Participants who are currently pregnant or breast-feeding
- •17. A woman of child-bearing potential (WOCBP) who does not agree to use a method of birth control (including barrier methods) during heterosexual intercourse from screening until 1 day after last trial treatment (see notes below)
- •18. Females of childbearing potential using hormonal contraception for less than 3 months prior to trial entry, or using hormonal contraception and not willing to stay on it for the duration of trial
- •19. Females taking Hormone Replacement Therapy (HRT) not willing to remain on treatment for the trial duration or have started HRT within the last 3 months prior to trial entry or are on an unstable dose of HRT
- •20. Male, if not vasectomised, who does not agree to use barrier contraception (condom) during heterosexual intercourse from screening through to 1 day after the last dose of trial treatment.
- •For Stage 2 only
- •1. Previous entry into the trial
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