CTRI/2021/05/033314尚未招募2 期
An open-label, single-arm clinical study to evaluateefficacy, safety and tolerability of tacrolimus lipid suspension for ophthalmic drops in adult patients of allergic conjunctivitis refractory to standard treatment
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 7
- 主要终点
- Improvement (in the form of mean percentage change) from baseline in redness score (using the 4-point standardized rating scale) and itching score (using the 5-point standardized rating scale) at week 4 in each affected eye
研究概览
简要总结
This is an open-label, single-arm clinical study to evaluate efficacy, safety and tolerability of tacrolimus lipid suspension for ophthalmic drops in adult patients of allergic conjunctivitis refractory to standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinical diagnosis of bilateral allergic conjunctivitis (AC) made by an experienced ophthalmologist following recording of symptoms based on complete ophthalmic examination as per standard clinical practice using determination of visual acuity, slit-lamp biomicroscopy and indirect ophthalmoscopy, whenever required.
- •Not responsive to treatment with first line therapeutic agents for sufficient duration as per the best discretion of the Investigator which must include cold compress, artificial tears, topical over the counter preparations, anti-histaminics, mast cell stabilizers and / or topical corticosteroids depending upon the severity of disease
- •Female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at the start of treatment.
- •Surgically sterile, post-menopausal, or sexually abstinent patient or partner must agree to use a medically appropriate form of birth control from screening until 14 + 2 day after the last dose of study medication.
- •The patients who are able to understand and sign a written informed consent form, which is obtained prior to initiation of study procedures.
排除标准
- •1.Presence of co-existing ocular diseases such as glaucoma, dry eye syndrome, uveitis, ocular infection.
- •2.Presence of systemic diseases other than co-existing allergic rhinitis, asthma and atopic dermatitis.
- •3.Patient with ocular structural abnormalities like lid scarring, entropion, trichiasis, etc.
- •4.Reported hypersensitivity to Tacrolimus or cyclosporine or have a history of serious AEs related to their use.
- •5.Patients wearing contact lenses.
- •6.Patients who could not discontinue receiving ocular vasoconstrictor and ocular nonsteroidal anti-inflammatory drugs at the start of study drug administration.
- •7.Patients who underwent cryosurgery or surgical excision of giant papillae of the eye(s) to which the study drug was to be instilled within 4 weeks prior to the start of study drug administration.
- •8.Patients who were receiving desensitization therapy or immune modulation therapy in any form 4 weeks prior to the start of study drug administration.
- •9.Patients who had cataract as a complication in the eye(s) to which the study drug was/were to be instilled, making it impossible to perform fundoscopy by mydriasis.
- •10.Expecting mothers, lactating mothers, or women wishing to become pregnant.
- •11.Patients with malignant tumors either as a concomitant disease or a history.
- •(Patients in whom malignant tumors had not recurred more than for 10 years are eligible).
- •12.Patients with systemic infectious disease.
- •13.Patients who are receiving treatment requiring hospitalization.
- •14.History of chemical substance abuse.
- •15.Patients with repeated anti-inflammatory drug treatment 16.Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.
- •17.Patients who had participated in any other clinical or post-marketing studies (not only for study drugs but also for medical devices) before 60 days from the day of screening.
结局指标
主要结局
Improvement (in the form of mean percentage change) from baseline in redness score (using the 4-point standardized rating scale) and itching score (using the 5-point standardized rating scale) at week 4 in each affected eye
时间窗: At week 4
次要结局
- - Improvement from baseline in allergic conjunctivitis as per physician s and patient s evaluation of global efficacy at week 4 in each affected eye.(- Improvement in total scoring of ocular signs and symptoms at week 4 against baseline in each affected eye.)
研究者
研究点 (7)
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