CTRI/2024/01/062038尚未招募4 期
An Open Label, Prospective, Non-comparative, Multicentric, Phase IV Clinical Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Tropicamide 0.02% w/v + Phenylephrine Hydrochloride 0.31% w/v + Lidocaine Hydrochloride 1% w/v Ophthalmic Solution for Injection for Anaesthesia and Mydriasis in Cataract Surgery. ? - NI
Appasamy Ocular Devices (P) Ltd.0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1. Male or female patients aged between 18 to 75 years (both inclusive).
- •2. Patients having grade 2 to 3 cataract at screening visit.
- •3. Patients are scheduled to undergo surgery for cataract.
- •4. Patients with endothelial cell count more than 2000 cell per mm2 at screening visit.
- •5. Patients with pupil diameter morethan or equal to 7 mm at screening visit.
- •6. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening or baseline visit.
- •7. Patient with ability to understand and provide written, dated and signed informed consent form, which must have been obtained prior to screening.
- •8. Patients willing to comply with all the protocol requirements.
排除标准
- •1. Patients with corrected visual acuity less than 0.5.
- •2. Patients with refractive error with a spherical equivalent more than +6 or smaller - 6 D.
- •3. Patients with elevated intraocular pressure (higher than 22 mmHg).
- •4. Patients with current or history within two months prior to screening visit of significant ocular disease, e.g., corneal denervation, corneal epithelial defects, dry eye syndrome, ocular trauma to the operative eye, corneal edema, proliferative diabetic retinopathy in the operative eye or ocular infection.
- •5. Patients with the operative eye, history of chronic or recurrent inflammatory disease, e.g., iritis, scleritis, uveitis, iridocyclitis or rubeosis iritis, lens pseudoexfoliation syndrome with glaucoma or zonular compromise of congenital ocular anomaly, e.g., aniridia or congenital cataract.
- •6. Patients with iris atrophy in the operative eye.
- •7. Patients with combined surgery.
- •8. Patients with clinically significant ocular endothelial dysfunction.
- •9. Patients with history of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery.
- •10. Patients who are using topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to screening visit.
- •11. Patients with nonfunctional nonoperative eye.
- •12. Patients with any laboratory value outside the clinically accepted reference range.
- •13. Patients with type 1 or uncontrolled type 2 diabetes mellitus.
- •14. Patients with uncontrolled hypertension with sitting systolic BP more than 140 mmHg and or diastolic BP more than 90 mmHg.
- •15. Patients with a history of orthostatic hypotension, fainting spells or blackout.
- •16. Patients with clinically relevant recent current or past history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, metabolic, autoimmune disease and other relevant systemic diseases or bleeding tendencies that would preclude the safe administration of the investigational product.
- •17. Patients who are using the following concomitant medications will not be allowed:
- •Systemic corticoid treatments and immunosuppressive treatments within 3 months before surgery.
- •Systemic opioids and morphinic drugs within 7 days before surgery.
- •Topical ocular treatment with mydriatic and or anaesthetic action within 7 days before surgery.
- •Topical treatment with anti-inflammatory and antibiotic action within 1 day before surgery (except for the preoperative treatment specified in this protocol).
- •Anxiolytics and hypnotics on the day of surgery; adrenaline or any other agent with a mydriatic action in the intraocular irrigating solution on the day of surgery.
- •18. Patients with a history of central nervous system disease (such as epilepsy) or psychiatric disorders or neurological disorders.
- •19. Patients with known hypersensitivity to any of the topical formulation (Tropicamide, Phenylephrine and Lidocaine).
- •20. Patients who are using any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study.
- •21. Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
- •22. Female patients who are of childbearing potential and who are neither surgic
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