CTRI/2022/08/044716已完成3 期
A Multi Centre, Randomized, Double Masked, Placebo-Controlled, Parallel-Group, Phase III Comparison Study to Assess Efficacy and Safety of Bibrocathol 2% Eye Ointment (Posiformin 2%) in the treatment of Chronic Blepharoconjuctivitis. - NA
rsapharm India Pvt Ltd0 个研究点目标入组 196 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
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
入选标准
- •1. Written informed consent.
- •2. Ambulatory male and female patients >= 18 years of age
- •3. Diagnosis of a chronic blepharoconjunctivitis
- •4. Summarized score of signs and symptoms (sum score of severity of lid oedema, lid erythema, debris, hyperemia and pouting of Meibomian glands and additionally the patientâ??s assessment of ocular discomfort) of >= 18 at baseline.
排除标准
- •Exclusion Criteria:
- •1.Ocular conditions:
- •a.chronic blepharoconjunctivitis requiring antibiotic treatment
- •therapy-resistant chronic blepharoconjunctivitis
- •b.acute ocular and/or follicle- or lid- infection or active ocular inflammation other than blepharoconjunctivitis
- •c.irritations of the outer eye that are related to corneal damage (e. g. erosions, injuries, burns)
- •d.abnormal eye lid anatomy (other than due to chronic blepharoconjunctivitis)
- •e.Ocular surgery within 90 days (trauma, intraocular surgery, refractive surgery, palpebral surgery (e.g. ectopium OP), etc.)
- •f.severe dry eye syndrome also due to systemic diseases
- •allergic eye disease
- •IOP >= 21 mmHg (non-contact tonometry)
- •changes in performance of lid hygiene during the trial
- •2.Systemic condition:
- •a.known hypersensitivity to the investigational product or any of its ingredients
- •b.severe systemic disease
- •c.rheumatoid arthritis or spondylitis
- •d.subjects with history of malignancy of any organ system, treated or untreated, within the past five years, whether or not evidence of local recurrence or metastases exists, are excluded
- •3.Concomitant medication:
- •a.oral or topical antibiotics 2 weeks prior to and/ or during the trial
- •b.any other ocular antiseptics during the trial
- •c.topical ocular or systemic corticosteroids 2 weeks prior to and/ or during the trial (except chronic use of inhalative corticosteroids if on stable dose one month prior to and during the trial)
- •d.topical ocular and systemic NSAIDs 2 weeks prior to and/ or during the trial (low dose oral acetylsalicylic acid and occasional use of painkillers is allowed)
- •e.local ocular use of antihistamines one month and prior to and/ or during the trial
- •f.ocular α-sympathomimetics one month and prior to and/ or during the trial
- •a.any eye cosmetics during the trial
- •b.patients who anticipate changes in their ongoing regimen of concurrent systemic therapies that could affect trial parameters
- •c.wearing contact lenses during the trial
- •d.pregnant or breast feeding women
- •e.women with childbearing potential, not using a reliable and medically accepted method of contraception (no pregnancy test is required in women, being 2 years after menopause)
- •f.any systemic or ocular medical or physical condition which, in the investigatorâ??s opinion, would preclude the participant from adhering to the protocol or completing the trial per protocol.
- •g.patients participating in another clinical trial at the same time
- •h.patients taking any investigational product 4 weeks prior to the trial
- •i.patients already once included in the trial
研究者
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