CTRI/2015/11/006338已完成3 期
A Clinical Trial to Study the Efficacy, Safety and Tolerability of Alcaftadine eye drops Vs. Olopatadine hydrochloride eye drops in Subjects Suffering from Allergic Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 204
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. The study will be conducted in 2 stages:
- •In 1st stage subjects between 18 to 60 years (both inclusive) will be enrolled. Based on the outcome of 1st stage of the study and its report submitted to the committee, in the 2nd stage, study will be conducted on 10 to less than 18 years age group of subjects.
- •2. Subjects with diagnosis of allergic conjunctivitis.
- •3. Freshly diagnosed or subject who are previously diagnosed and on treatment of Allergic conjunctivitis will undergo washout period for 3 days.
- •4. Voluntary willingness of patient to give written as well as Audio-Visual informed consent prior to participation in clinical trial. For Minor subject LAR (Legally Acceptable Representative) should be taken with assent form.
排除标准
- •1. Male and female subjects <10 years and >60 years of age.
- •2. Women who were not using an effective means of contraception or who are pregnant or nursing.
- •3. Visual acuity of 20/40 in any eye.
- •4. Subject who are blind or subject with single eye.
- •5. Subject with history of active stage of any other concomitant ocular disease.
- •6. Contraindication or sensitivity to any component of study treatment.
- •7. Subject having history of chronic use of ocular medication other than the study drug, progressive or functionally visual field loss within the past year.
- •8. Contact lens user.
- •9. Subject who are schedule to undergo surgery of the eye during the study period.
- •10. Subject with known history of ocular inflammation or any other condition that in the opinion of the investigator that does not justify the patientâ??s participation in the study.
- •11. Participation in an ophthalmic drug or device research study within 30 days prior to entry into the study.
- •12. Subject not willing to comply with the study protocol and provide written informed consent to participation.
- •13. Any disease or condition that could interfere with the safety and efficacy evaluation of the study medication.
- •14. Have used H1-antagonist antihistamines within 72 hours.
- •15. Subjects who took systemic administration of corticosteroids or immunosuppressive agents, or used ophthalmic ointments of corticosteroids within 1 week before instillation of the investigational drugs.
- •16. Subject with Schirmer <10 should be excluded from the study.
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