“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.â€
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 9
- 主要终点
- Proportion of patients reporting incidences of AE and or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.
研究概览
简要总结
This trial is 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.
Patients who are willing and able to participate in the study will sign and date the Informed Consent Form on the day of screening / baseline visit (Visit 1). During this screening period, patients who are willing to give consent will be evaluated for all the eligibility criteria. Eligible patients (male or female) aged between 18 to 75 years (both inclusive) meeting all the inclusion criteria and none of the exclusion criteria will be enrolled into the study.
After confirming the inclusion/exclusion criteria the subject will be enrolled and provided with study medication at enrolment visit (Day 1 - Day of Surgery). Follow up visits will be done on visit 3 (12 to 36 hours post-surgery), week 1/day 7(±2) and week 4/day 28(±2) (Final Visit) of treatment to assess safety and efficacy.
After enrolment patients will be planned for cataract surgery at visit 2 and the day will be considered as Day 1 (Day of Surgery). Five minutes before performing the preoperative antiseptic procedure and the first incision, one to two drops of anaesthetic eye drops should be instilled in the eye. At the beginning of surgery, 0.2 mL of FDC of Tropicamide 0.02% w/v + Phenylephrine Hydrochloride 0.31% w/v + Lidocaine Hydrochloride 1% w/v Ophthalmic Solution for Injection is slowly injected in only one injection by an ophthalmic surgeon, via intracameral route, through the side port or principal port or as directed by physician / principal investigator / co-investigator.
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
- •Male or female patients aged between 18 to 75 years (both inclusive).
- •Patients having grade 2 to 3 cataract at screening visit.
- •Patients are scheduled to undergo surgery for cataract.
- •Patients with endothelial cell count more than 2000 cell per mm2 at screening visit.
- •Patients with pupil diameter morethan or equal to 7 mm at screening visit.
- •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.
- •Patient with ability to understand and provide written, dated and signed informed consent form, which must have been obtained prior to screening.
- •Patients willing to comply with all the protocol requirements.
排除标准
- •Patients with corrected visual acuity less than 0.
- •Patients with refractive error with a spherical equivalent more than +6 or smaller.
- •Patients with elevated intraocular pressure (higher than 22 mmHg).
- •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.
- •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.
- •Patients with iris atrophy in the operative eye.
- •Patients with combined surgery.
- •Patients with clinically significant ocular endothelial dysfunction.
- •Patients with history of eye surgery apart from laser trabeculoplasty less than three months previously or extraocular surgery such as strabismus surgery.
- •Patients who are using topical ocular medication influencing IOP (intraocular pressure) or pupil size within 3 months prior to screening visit.
- •Patients with nonfunctional nonoperative eye.
- •Patients with any laboratory value outside the clinically accepted reference range.
- •Patients with type 1 or uncontrolled type 2 diabetes mellitus.
- •Patients with uncontrolled hypertension with sitting systolic BP more than 140 mmHg and or diastolic BP more than 90 mmHg.
- •Patients with a history of orthostatic hypotension, fainting spells or blackout.
- •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.
- •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.
- •Patients with a history of central nervous system disease (such as epilepsy) or psychiatric disorders or neurological disorders.
- •Patients with known hypersensitivity to any of the topical formulation (Tropicamide, Phenylephrine and Lidocaine).
- •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.
- •Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
- •Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
- •Patients with a history of any malignancy.
- •Patients with known case of infection with hepatitis B, hepatitis C or HIV.
- •Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •Patients currently taking any of the prohibited medications(s) and inability or unwillingness to discontinue them for the entire study period.
- •Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
结局指标
主要结局
Proportion of patients reporting incidences of AE and or SAE during the study and their assessment in respect to intensity, duration, pattern and causal relationship to the study medication.
时间窗: From Day 1 (i.e., Day of Surgery) to End of the study visit or Week 4 (Day 28±2).
次要结局
- Change in best corrected visual acuity according to the Snellen test from baseline to end of the study visit.(Visit 1 - Screening or Baseline visit (Day -3),)
- Percentage of patients with epithelial alterations evidenced by slit-lamp examination at visit 3 and visit 4.(Visit 1 - Screening or Baseline visit (Day -3),)
- Change in endothelial cells count from baseline to end of the study visit.(Visit 1 - Screening or Baseline visit (Day -3),)
- Change in intraocular pressure (IOP) from baseline to end of the study visit.(Visit 1 - Screening or Baseline visit (Day -3),)
- Percentage of patients achieving capsulorhexis (pupil diameter) without use of any additional mydriatic treatment.(Visit 1 - Screening or Baseline visit (Day -3),)
- Change in ocular pain and discomfort from baseline to end of the study visit.(Visit 1 - Screening or Baseline visit (Day -3),)
- Patient’s satisfaction with study medication as assessed on an ordinal scale at visit 2 to end of the study visit.(Visit 2 - Enrollment visit (Day 1) - Day of Surgery,)
- Investigator’s satisfaction with study treatment as assessed on an ordinal scale at visit 2 to end of the study visit.(Visit 2 - Enrollment visit (Day 1) - Day of Surgery,)
研究者
Dr Rajasekhara Reddy Tamma
Clinwave Research Pvt. Ltd.