CTRI/2024/01/062038 [Registered on: 30/01/2024] Trial Registered Prospectively
Last Modified On:
08/10/2024
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
A clinical study to evaluate the safety and efficacy of Tropicamide, Phenylephrine and Lidocaine injection in patients undergoing lens replacement surgery.
Scientific Title of Study
“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€
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/2023/31, Version No.: 00 and Dated May 01, 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B/466, H. No.: 1-16-10/466,
Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Hyderabad TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B/466, H. No.: 1-16-10/466,
Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Hyderabad TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B/466, H. No.: 1-16-10/466,
Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Institutional Ethics Committee for Human Research, Medical College and Hospital
Approved
Institutional Ethics Committee, GCS Medical College, Hospital and Research Centre
Approved
Institutional Ethics Committee, Jawahar Lal Nehru (J.L.N) Medical College
Approved
Institutional Ethics Committee, King George Hospital
Submittted/Under Review
Institutional Ethics Committee, King George’s Medical University
Submittted/Under Review
North East Healthcare Private Limited, W Pratiksha Hospital
Submittted/Under Review
Prakash Medical College Institutional Ethics Committee, Prakash Institute of Medical Sciences & Research (PIMS&R)
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: H269||Unspecified cataract,
Intervention / Comparator Agent
Type
Name
Details
Intervention
FDC of Tropicamide plus Phenylephrine Hydrochloride plus Lidocaine Hydrochloride Ophthalmic Solution for Injection
It is administered by an ophthalmic surgeon by injection into the eye at the beginning of cataract surgery, in order to enlarge the pupil of your eye (Mydriasis) and to obtain anaesthesia in your eye during the surgical procedure.
The following procedure should be followed:
1. 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.
2. At the beginning of surgery, 0.2 mL of FDC of Tropicamide plus Phenylephrine Hydrochloride plus Lidocaine Hydrochloride 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 or principal investigator or co-investigator.
Comparator Agent
NA
NA
Inclusion Criteria
Age From
18.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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 surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
23. Patients with a history of any malignancy.
24. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
25. 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.
26. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
27. Patients currently taking any of the prohibited medications(s) and inability or unwillingness to discontinue them for the entire study period.
28. 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.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
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.
From Day 1 (i.e., Day of Surgery) to End of the study visit or Week 4 (Day 28±2).
Secondary Outcome
Outcome
TimePoints
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),
Visit 3 - Follow up visit - 12 to 36 hours post-surgery,
Visit 4 - Follow up visit or Week 1 (Day 7±2) and
Visit 5 - End of the study visit or Week 4 (Day 28±2).
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),
Visit 3 - Follow up visit - 12 to 36 hours post-surgery,
Visit 4 - Follow up visit or Week 1 (Day 7±2) and
Visit 5 - End of the study visit or Week 4 (Day 28±2).
Change in endothelial cells count from baseline to end of the study visit.
Visit 1 - Screening or Baseline visit (Day -3),
Visit 3 - Follow up visit - 12 to 36 hours post-surgery,
Visit 4 - Follow up visit or Week 1 (Day 7±2) and
Visit 5 - End of the study visit or Week 4 (Day 28±2).
Change in intraocular pressure (IOP) from baseline to end of the study visit.
Visit 1 - Screening or Baseline visit (Day -3),
Visit 3 - Follow up visit - 12 to 36 hours post-surgery,
Visit 4 - Follow up visit or Week 1 (Day 7±2) and
Visit 5 - End of the study visit or Week 4 (Day 28±2).
Percentage of patients achieving capsulorhexis (pupil diameter) without use of any additional mydriatic treatment.
Visit 1 - Screening or Baseline visit (Day -3),
Visit 2 - Enrollment visit (Day 1) - Day of Surgery,
Visit 3 - Follow up visit - 12 to 36 hours post-surgery,
Visit 4 - Follow up visit or Week 1 (Day 7±2) and
Visit 5 - End of the study visit 0r Week 4 (Day 28±2).
Change in ocular pain and discomfort from baseline to end of the study visit.
Visit 1 - Screening or Baseline visit (Day -3),
Visit 2 - Enrollment visit (Day 1) - Day of Surgery,
Visit 3 - Follow up visit - 12 to 36 hours post-surgery,
Visit 4 - Follow up visit or Week 1 (Day 7±2) and
Visit 5 - End of the study visit 0r Week 4 (Day 28±2).
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,
Visit 3 - Follow up visit - 12 to 36 hours post-surgery,
Visit 4 - Follow up visit or Week 1 (Day 7±2) and
Visit 5 - End of the study visit 0r Week 4 (Day 28±2).
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,
Visit 3 - Follow up visit - 12 to 36 hours post-surgery,
Visit 4 - Follow up visit or Week 1 (Day 7±2) and
Visit 5 - End of the study visit 0r Week 4 (Day 28±2).
Target Sample Size
Total Sample Size="220" Sample Size from India="220" Final Enrollment numbers achieved (Total)= "220" Final Enrollment numbers achieved (India)="220"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
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.