| CTRI Number |
CTRI/2024/11/076757 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study on eye drop in refractive errors. |
|
Scientific Title of Study
|
An Open Label, Randomized, Multicenter, Prospective, Comparative Clinical Study to evaluate Efficacy and Safety of Isotine Plus I Eye Drop and Capsule Iso fala in participants with Myopia and Presbyopia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ISO/MYOPIA/JAGAT/2024/1, Version 1.0, 24th AUG 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pushpalata D Ingale |
| Designation |
Assistant Professor (Shalakya Tantra) |
| Affiliation |
Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Nashik |
| Address |
Department of Shalakya Tantra OPD No 5, Ground Floor,
Ayurved Seva Sanghs, Ayurved Mahavidyalaya,
Ganeshwadi, Panchavati, Nashik, MAHARASHTRA
Nashik
MAHARASHTRA
422003
India |
| Phone |
08208780841 |
| Fax |
|
| Email |
pdingaledr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jagat Pharma Pvt. Ltd
No- 23 B, Stadium Rd,
Model Town, Bareilly, Uttar Pradesh 243122 |
|
|
Primary Sponsor
|
| Name |
Jagat Pharma Pvt. Ltd |
| Address |
No- 23 B, Stadium Rd,
Model Town, Bareilly, Uttar Pradesh 243122 |
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pushpalata D Ingale |
Ayurved Seva Sanghs, Ayurved Mahavidyalaya |
Department of Shalakya Tantra OPD No 5, Ground Floor,
Ayurved Seva Sanghs, Ayurved Mahavidyalaya,
Ganeshwadi, Panchavati, Nashik, MAHARASHTRA
Nashik
MAHARASHTRA |
8208780841
pdingaledr@gmail.com |
| Dr Prabhakar Vardhan |
National Institute of Ayurveda |
OPD No 14, Ground Floor, Department of Shalakya Tantra, National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan, 302002
Jaipur
RAJASTHAN |
9461065960
prabhakar.salakya@nia.edu.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurved Seva Sanghs, Ayurved Mahavidyalaya, Nashik |
Approved |
| Institutional Ethics Committee, National Institute of Ayurveda Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, (2) ICD-10 Condition:H524||Presbyopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Isotine Plus I Eye Drop and Capsule Iso fala, Reference: NA, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Samudga, Duration: 180 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Moisturizing eye drop | Standard treatment group will be given moisturizing eye drop for a period of 6 months |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Cohort 1:
1. Equal number of participants will be recruited in the age group of 8 to 16 years and 16 to 30 years
2. Spherical equivalent refraction (SER): -1.00 to -5.00D
3. Parents willing to sign informed consent and allow their children to undergo all the study procedure.
Cohort 2:
1. Literate Male or Female between 40 and 55 years of age.
2. Distance-corrected near visual acuity (DCNVA) for each eye, as well as for
binocular vision, equivalent to 0.3 logMAR or worse; or 20 by 40 Snellen or worse at 40 cm
3. Subjects willing to sign informed consent and to undergo all the study procedure
|
|
| ExclusionCriteria |
| Details |
Cohort 1:
1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening.
3. History of any disease or syndrome predisposing the subject to severe myopia (Marfan syndrome, Stickler syndrome, retinopathy of prematurity, etc.).
4. History of clinically significant systemic disease including hypertension, diabetes, cardiac, endocrine, respiratory, neurologic, down syndrome, etc. that might interfere with the study as deemed by the Investigator
5. History or current history of glaucoma or ocular hypertension.
6. History of any refractive ocular anatomical anomaly (keratoconus, lenticonus, spherophakia, aphakia, etc.).
7. History of ocular diseases, excluding myopia (corneal alterations/opacities, cataract, retinal alterations, inflammatory diseases, etc.).
8. History of any type of ocular surgery.
9. Having participated in clinical research studies 30 days prior to inclusion in the present study.
10. Present active inflammatory or infectious ocular disease at the time of study entry.
11. Having undergone surgical procedures, not ophthalmologic, within the last 3 months.
12. Chronic use of any topical or systemic antimuscarinic/anticholinergic medication (atropine, scopolamine, tropicamide) within 21 days prior to screening, and/or anticipated need for its chronic use during the study period (more than 7 consecutive days in a month or more than 30 days total in a year).
13. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
14. Known allergy, hypersensitivity, or contraindication to any component of the study medications.
15. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
Cohort 2:
1. Use of any topical prescription or OTC ophthalmic medications of any kind within 7 days of Screening until study completion.
2. Use of any over-the-counter (OTC) artificial tears (preserved or unpreserved) at least once per day within 7 days of Screening.
3. Clinically significant ocular disease that might interfere with the study as deemed by the Investigator.
4. Recent or current evidence of ocular infection or inflammation in either eye.
5. Any history of herpes simplex or herpes zoster keratitis.
6. History of diabetic retinopathy or diabetic macular edema.
7. Known allergy, hypersensitivity, or contraindication to any component of the study medications.
8. History of cauterization of the punctum or punctal plug (silicone or collagen) insertion or removal.
9. Ocular trauma, ocular surgery, ocular laser treatment within the 6 months prior to screening.
10. Any subject with multifocal intraocular lenses will be excluded.
11. History of any traumatic (surgical or nonsurgical) or non-traumatic condition affecting the pupil or iris.
12. Clinically significant systemic disease including hypertension and diabetes that might interfere with the study as deemed by the Investigator.
13. Participation in any investigational study within 30 days prior to Screening.
14. Females of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
15. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his/her participation in, and completion of the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cohort 1:
Comparative difference in Autorefraction (Spherical equivalent)
Cohort 2:
Number of Subjects With greater than or equal to 3 Lines Gain in Near Best Distance Corrected Visual Acuity (BDCVA) (at 40 cm)
|
Baseline visit (Day 0), Every month assessment till 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cohort 1:
1. Comparative change in clinical symptoms
2. Comparative change in axial length
3. Comparative difference in corneal curvature
4. Comparative difference in visual acuity
5. Comparative assessment of vision targeted health status
6. Global assessment of overall change by investigator and subject
7. Global assessment of tolerability of study products by investigator and subject
8. Assessment of adverse events.
Cohort 2:
1). Comparative change in clinical symptoms
2). Quality of Life
3). Comparative assessment of vision targeted health status
4). Global assessment of overall change by investigator and subject
5). Global assessment of tolerability of study products by investigator and subject
6). Assessment of adverse events
|
Baseline visit (Day 0), Every month assessment till 6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is an open label, randomized,
multi-center, prospective, comparative clinical study to evaluate efficacy and safety
of Isotine Plus I Eye Drop and Capsule Iso fala in participants with Myopia and
Presbyopia. The study will be carried out at 4 to 5 centres in India. There
will be two cohorts as Cohort 1 (Participants with myopia) and Cohort 2 (Participants
with presbyopia). As per computer generated randomization list, subjects
will be randomized either to ISOTINE PLUS I EYE DROP and Capsule Iso fala group or
Standard treatment group in 1: 1 ratio. Subjects in ISOTINE PLUS I EYE DROP and
Capsule Iso fala group, will be asked to use ISOTINE PLUS I EYE DROP in a dose
of 1 drop in each eye 4-5 times daily and 1 Capsule Iso fala twice daily orally
after meals with water for 6 months. Subjects in the standard treatment group
will be given moisturizing eye drops for a period of 6 months.
Cohort 1: The primary objective of the cohort 1 will be to assess comparative difference in Autorefraction
(Spherical equivalent). Secondary objectives of the cohort 1 will be to assess comparative
change in clinical symptoms, comparative change in axial length, comparative
difference in corneal curvature, comparative difference in visual acuity, comparative
assessment of vision targeted health status, global assessment of overall
change by investigator and subject, global assessment of tolerability of study
products by investigator and subject and adverse events. Cohort 2: The primary objective
of the cohort 2 will be to assess Number
of Subjects With greater than or equal to 3 Lines Gain in Near Best Distance
Corrected Visual Acuity (BDCVA) (at 40 cm). Secondary objectives of the cohort 2
will be to assess comparative change in clinical symptoms, quality of Life, comparative
assessment of vision targeted health status, global assessment of overall
change by investigator and subject, global assessment of tolerability of study
products by investigator and subject and of adverse events on baseline visit
(Day 0) and every month assessment till 6 months |