A Phase IV, Multicentre, Open Label Clinical Study to Evaluate The Safety and Efficacy of Intracameral Phenocaine Plus Injection for Anaesthesia and Mydriasis in Cataract Surgery.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 219
- 试验地点
- 14
- 主要终点
- 3.Percentage of subjects with epithelial alterations evidenced by slit-lamp examination at visit 3 and visit 4.
研究概览
简要总结
A Study is A Phase IV,multicentre, open label, clinical study to evaluate the safety and efficacy ofintracameral Phenocaine Plus injection foranaesthesia and mydriasis in cataract surgery**.**
Primary Endpoints
The incidence of Adverse Events related to studymedication.
Change in best corrected visual acuity according tothe Snellen test from baseline to end of study
Percentage of subjects with epithelial alterationsevidenced by slit-lamp examination at visit 3 and visit 4.
Change in endothelial cells count from baseline to endof study.
Change in intraocular pressure from baseline to end ofstudy.
Secondary Endpoints
Percentage of subjects achievingcapsulorhexis (Pupil diameter) without use of any additive mydriatic treatment.
Change in Ocular pain and discomfort from baseline toend of study.
Subjects’ satisfaction with study medications asassessed on an ordinal scale at visit 2 to end of the study.
Investigator’s satisfaction with study treatmentsas assessed on an ordinal scale at visit 2 to end of the study
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female subjects of age between 18 to 75 years (both inclusive).
- •2.Subjects having grade 2 to 3 Cataract shall be included.
- •3.Subjects scheduled to undergo surgery for cataract.
- •4.Endothelial cell count > 2000 cell/mm
- •5.Pupil diameter ≥ 7 mm at screening.
- •6.Subjects who are willing to sign informed consent for participation in the study and willing to adhere to all protocol procedures.
排除标准
- •1.Corrected visual acuity < 0.
- •2.Refractive Error with a spherical equivalent > +6 or smaller.
- •6 D. 3.Elevated intraocular pressure (higher than 22 mmHg). 4.Current or history within two months prior to baseline 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.In 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.Iris atrophy in the operative eye. 7.Combined surgery 8.Clinically significant ocular endothelial dysfunction. 9.History of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery. 10.Topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to study-start. 11.Nonfunctional nonoperative eye. 12.Any laboratory value outside the clinically accepted reference range 13.Subjects with Type 1 or Uncontrolled Type 2 Diabetes mellitus. 14.History of uncontrolled hypertension with blood pressure > 140/90 mmhg. 15.History of orthostatic hypotension, fainting spells or blackout. 16.Subjects 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.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. 19.Known hypersensitivity to the active substances (tropicamide, phenylephrine, lidocaine,) or any of their excipients 20.Use of 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 subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study. 22.History of alcohol abuse and smoking. 23.Concurrent participation in another clinical trial or any investigational therapy within two months prior to signing informed consent.
结局指标
主要结局
3.Percentage of subjects with epithelial alterations evidenced by slit-lamp examination at visit 3 and visit 4.
时间窗: 28 days
1.The incidence of Adverse Events related to study medication.
时间窗: 28 days
2.Change in best corrected visual acuity according to the Snellen test from baseline to end of study
时间窗: 28 days
4.Change in endothelial cells count from baseline to end of study.
时间窗: 28 days
5.Change in intraocular pressure from baseline to end of study.
时间窗: 28 days
次要结局
- 1.Percentage of subjects achieving capsulorhexis (Pupil diameter) without use of any additive mydriatic treatment.(2.Change in Ocular pain and discomfort from baseline to end of study.)