EUCTR2017-002835-40-ES进行中（未招募）1 期
Topical rVA576 for treatment of atopic keratoconjunctivitis: a randomised placebo double masked parallel trial (TRACKER) - TRACKER
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients must meet the following criteria in order to be included in the study:
- •Inclusion Criteria:
- •1. Aged 18 and above
- •2. Diagnosis of moderate to severe AKC, VKC, or severe allergic conjunctivitis (seasonal or perennial). Defined as:
- •AKC, VKC - a composite symptom/sign score from one eye of = 18 out of 33 (see Clinical Scoring Section 17.1)
- •Severe allergic conjunctivitis (SAC or PAC) - a composite symptom/sign score from one eye of = 15 out of 27 (see Clinical Scoring Section 17.2)
- •3. Will have had received some topical therapy during the last 3 months without improvement but will not currently be receiving systemic immunotherapy. Topical therapy may be topical cyclosporin, antihistamines or corticosteroids alone or in combination. Lubricants or artificial tears will not a count as topical therapy for these purposes.
- •4. Will have had at least 7 days without topical ocular corticosteroids prior to entry
- •5. Willing to give informed consent
- •6. Willing to use highly effective contraceptive precautions for the duration of the study and for 90 days after the last dose of IMP
- •7. Willing to avoid prohibited medications for duration of study (see list of prohibited medications)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 19
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •A patient will not be eligible for the study if he/she meets one or more of the following criteria:
- •Exclusion Criteria:
- •1. Eye surface disease other than AKC, VKC or severe allergic conjunctivitis (SAC or PAC)
- •2. Contact lens use during the study
- •3. Complete or partial tarsorrhaphy. If such a procedure becomes necessary during the course of the trial patients may remain in the trial providing that at least 50% of the eye surface remains visible to slit lamp examination
- •4. Ankyloblepharon of any degree at entry to the trial
- •5. Known or suspected ocular malignancy
- •6. Active ocular infection at entry to the trial. Patients with eye surface bacterial, viral, fungal or protozoal infection may enter the trial after elimination of the infection as confirmed by eye swabs
- •7. Known or suspected uveitis
- •8. Participation in any other clinical trial within 1 month of enrolment
- •9. Use of any of the following prohibited medications:
- •Eculizumab
- •Any other investigational complement inhibitor whether systemic or topical (e.g. RA101495)
- •Montelukast
- •Zafirlukast
- •Pranlukast
- •Hypericum perforatum (St John’s wort)
- •10. Corneal perforation
- •11. Uncontrolled glaucoma (increase in dose of glaucoma medication or surgical intervention for glaucoma within 3 months prior to entry)
- •12. Pregnancy (females)
- •13. Breast feeding (females)
- •14. Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom)
- •15. Use of topical ocular steroids within 7 days of the Screening visit
- •16. Failure to satisfy the PI of suitability to participate for any other reason
研究者
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