ISRCTN15464650已完成不适用
Efficacy and safety of Hydrocortison-POS N 1% and 2.5% versus Ficortril 0.5% in the treatment of acute inflammation of the ocular surface or adnexa for which steroid treatment is indicated - a multi-centre, randomised, double-blind, parallel-group, phase III comparison
RSAPHARM Arzneimittel GmbH (Germany)0 个研究点目标入组 411 人开始时间: 2013年9月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 411
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. Female or male outpatients aged 18 to 75 years old (inclusive) with a non-infectious disease of the eye and ocular adnexa, i.e., seasonal or perennial allergic conjunctivitis, acute allergic blepharitis or blepharoconjunctivitis, or allergic lid oedema, with acute inflammation of the ocular surface or adnexa for which topical steroid treatment is advisable
- •2. A clinical sum score of signs and symptoms of at least 10 with at least one item scored as ?2? (moderate) or ?3? (severe) at baseline.
排除标准
- •1. Incapability of understanding the language in which the written patient information is given
- •2. Presence or history of drug or alcohol abuse
- •3. Presence of any malignancy during the past 5 years
- •4. The patient is a woman of childbearing potential who does not use a reliable method of contraception
- •5. The patient is a pregnant or breast feeding woman
- •6. Participation in a concurrent clinical trial or in another trial within the past 4 weeks
- •7. Previous participation in this trial or the patient is the investigator him/herself
- •8. Pre-treatment which is not permitted
- •9. Concomitant treatment which is not permitted
- •10. Allergy or hypersensitivity to any ingredients of the trial medication
- •11. Any contraindication for the use of steroids: e.g. bacterial, some specific viral or fungal eye infections, glaucoma [except open-angle glaucoma with controlled Intraocular pressure (IOP)], cataract (except early-stage cataract), etc.
- •12. Findings with fluorescein corneal staining at baseline which prohibit steroid treatment
- •13. Eye discharge (yellowish) with score of 1 or above at baseline as assessed by the investigator
- •14. Ocular injury and/or ocular surgery within 3 months prior to trial participation (preceding intra ocular laser surgery expressively permitted)
- •15. Systemic or topical steroids within 1 month prior or during trial participation
- •16. Contact lenses
- •17. Changes in eye hygiene measures after study inclusion
- •18. Any systemic disease which prohibits steroid treatment, e.g. severe osteoporosis, unstable diabetes mellitus, Cushing syndrome, etc.
研究者
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