| CTRI Number |
CTRI/2025/07/090630 [Registered on: 10/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the safety,tolerability and effect of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 percentage w/v for the treatment in Participants with Presbyopia. |
|
Scientific Title of Study
|
A Multicenter, Open Label, Single-Arm, Phase IV Clinical Study to Evaluate the Safety, Tolerability and Efficacy of Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25 percentage w/v for the treatment in Participants with Presbyopia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BCR-EPL-003, Version 2.0, 1st amendment, dated 24 Apr 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohit Saxena |
| Designation |
Principal Investigator |
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Science |
| Address |
Department of ophthalmology, Room No-377, Third floor, All India Institute of Medical Sciences, Ansari Nagar, New Delhi India
New Delhi
DELHI
110029
India |
| Phone |
919868155230 |
| Fax |
|
| Email |
rohitsaxena80@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
Biosphere Clinical Research Pvt. Ltd. SB-02, 03 and 04, Second Floor Highland Corporate Centre, Kapurbawdi Junction, Thane West Maharashtra, India
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Nargundkar |
| Designation |
Managing Director |
| Affiliation |
Biosphere Clinical Research Pvt Ltd |
| Address |
SB-02, 03 and 04, Second Floor Highland Corporate Centre, Kapurbawdi Junction, Thane West Maharashtra, India
Thane
MAHARASHTRA
400607
India |
| Phone |
02241006794 |
| Fax |
|
| Email |
drneeta@biospherecro.com |
|
|
Source of Monetary or Material Support
|
| Entod Pharmaceuticals Ltd. Ashirwad building, Opp. Badi Masjid, S V Road, Bandra (W) Mumbai 400050, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Entod Pharmaceuticals Ltd. |
| Address |
Ashirwad building, Opp. Badi Masjid, S V Road, Bandra (W) Mumbai 400050, Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vijaya Sahu |
All India Institute of Medical Sciences, Raipur |
Department of Ophthalmology,
G.E. Road,Tatibandh, Raipur 492099 Chhattisgarh, India
Raipur
CHHATTISGARH |
9752679556
drvijayasahu77@gmail.com |
| Dr Sandeep Patil |
Belagavi Institute of Medical Sciences |
Belagavi Institute of Medical
Sciences, Dr. B R Ambedkar Road, Sadashiv Nagar Belagavi – 590001 Karnataka, India
Belgaum
KARNATAKA |
9945447572
drsandeepatil@gmail.com |
| Dr Mandlik Hanumant Rangnath |
Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital |
Department of Ophthalmology, Sangli- Miraj Rd,Wanalesawadi,
Sangli- 416416 Maharashtra, India
Sangli
MAHARASHTRA |
8329274070
hrmandlik@gmail.com |
| Dr Rohit Saxena |
Dr. Rajendra Prasad Centre for Ophthalmic Science |
Room 377, Third floor,All India Institute of Medical
Sciences, Ansari Nagar, New Delhi
110029, India.
New Delhi
DELHI |
9868155230
rohitsaxena80@gmail.com |
| Dr Sandhya Dharwadkar |
K R Hospital, Mysore Medical College and Research Institute |
Department of Ophthalmology, Mysore Medical College and Research Institute, Irwin
Road, Mysore-570001 Karnataka,
India
Mysore
KARNATAKA |
7204546124
drsandhyahegde@gmail.com |
| Dr Udayaditya Mukhopadhyay |
Nil Ratan Sircar Medical College and Hospital |
138 Acharya Jagadish Chandra Bose Road, Kolkata-700014, West Bengal, India
Kolkata
WEST BENGAL |
9830211833
udayadityam@yahoo.com |
| Dr Krishna Prasad Kudlu |
Prasad Netralaya Super Specialty Eye Hospital |
A.J Alse Road Behind Alankar Theatre Udupi– 576101, Karnataka India
Udupi
KARNATAKA |
9845102334
krishprasad73@gmail.com |
| Dr Mohita Sharma |
Tirupati Eye Centre and Research Institute |
Block- C. 53C. Sector-33 Noida, 201301, Uttar Pradesh, India
Gautam Buddha Nagar
UTTAR PRADESH |
9560889495
drmohita@tirupatieye.org |
| Dr Chandrashekhar Murlidhar Wavikar |
Wavikar Eye Institute |
Level 4 & 5, Amber Arcade
Bhiwandi Bypass Road, Near Lodha Paradise, Majiwada, Thane (W) -400601, Maharashtra, India
Thane
MAHARASHTRA |
7738097716
drcmwavikar@wavikareye.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee N.R.S. Medical College |
Approved |
| Ethics Committee Tirupati Eye Centre |
Approved |
| IEC-MMC and RI and Associated Hospital |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee BIMS Belagavi Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee BVDU Medical College and Hospital,Sangli |
Approved |
| Institutional Ethics Committee, AIIMS, Raipur |
Submittted/Under Review |
| Netrajyothi Institute Ethics Committee |
Approved |
| Wavikar Eye Hospital and Eye Institute Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H524||Presbyopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Pilocarpine Hydrochloride Ophthalmic solution USP 1.25 % w/v |
One drop of Pilocarpine Hydrochloride Ophthalmic solution USP 1.25 % w/v once daily in each eye (preferably in morning) for 120 days of
treatment duration. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult male and female participants, 45 to 55 years of age (both inclusive).
2. Participants with subjective complaints of poor near vision that impacts the activity of daily living.
3. Participants with photopic, high-contrast Corrected Distance Visual Acuity (CDVA) of 20/25 or better bilaterally; mesopic, high-contrast
Distance-Corrected Near Visual Acuity (DCNVA, measured at 40cm) of 20/40 to 20/100; photopic, near visual acuity correctable to 20/40 or better bilaterally.
4. Participants with willingness to wear monofocal correction to achieve photopic, binocular CDVA of 20/32 or better during the study.
5. Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures. |
|
| ExclusionCriteria |
| Details |
1. Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation or cholinergic agonist medications.
2. Participants with history of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any other intraocular surgery.
3. Participants with concurrent use of any topical ophthalmic medications including artificial tears, other than the study intervention during the course of the study.
4. Participants with concurrent use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.
5. Participants with severe dry eye disease.
6. Participants with pathological myopia.
7. Participants with corneal abnormalities (including Keratoconus,corneal scar, Fuchs endothelial dystrophy, guttata or edema) in either
eye that are likely to interfere the visual acuity.
8. Participants with history of iris trauma, Adies’ tonic pupil, abnormal pupil shape in either eye, or anisocoria greater than 1mm between pupils under mesopic conditions at the screening visit.
9. Participants with all grades of cataract.
10. Participants with diagnosis of Glaucoma or ocular Hypertension.
11. Narrow iridocorneal angles (Shaffer grade less than or equal to 2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy.
12. Participants with Bifocal or multifocal spectacles or contact lenses for habitual correction.
13. Lens opacity in either eye that is determined to cause significant disturbance of the central visual axis on screening biomicroscopy.
14. Participants with history of chronic, recurrent, or current severe inflammatory eye disease (i.e.scleritis, uveitis, herpes keratitis) in either eye.
15. Participants with documented history of ocular trauma 6 months before the study.
16. Participants with documented history of clinically significant or progressive retinal disease (e.g., retinal degeneration, retinal hole or tear, diabetic retinopathy, retinal detachment, peripheral retina is showing lattice degeneration) in either eye.
17. Participants with use of topical ophthalmic corticosteroid within two weeks prior to baseline visit.
18. Participants with use of intraocular corticosteroid implant at any time prior to baseline visit.
19. Presence of a severe or serious ocular condition or any other unstable medical condition that, in the Investigators opinion, may preclude study treatment or follow up.
20. Participants with clinically relevant current or past history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic and renal diseases.
21. Participants currently participating in any other clinical trial or has participated in any other clinical trial 30 days prior to screening.
22. Suspected inability or unwillingness to comply with the protocol or other study procedures.
23. Female participants who are pregnant or lactating or planning to become pregnant during the study period. Females or males who are not ready to use acceptable contraceptive methods during the course of study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The assessment of the safety of participants [Based on the incidence of treatment emergent adverse event(TEAE)].
2.The assessment of the tolerability of the study drug will be based on the incidence of AEs and SAEs. |
150 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Percentage of participants Gaining 3 Lines or More in Mesopic (10-11 lux at the target), High-contrast, Binocular Distance-Corrected Near Visual Acuity (DCNVA) on Day 120, hours 3, 6 and 9 [Time Frame: Baseline Day 1 to Day 120 (Hours 3, 6 and 9)]. |
120 Days |
| 2. Proportion of participants Achieving 20/40 or Better in Photopic (Greater than 251 lux at the target), High-contrast, Binocular, DCNVA on Day 120, hour3[ Time Frame: Day 120 (Hour 3)]. |
120 Days |
| 3. Mean change from baseline in photopic, high-contrast, binocular Distance-Corrected Intermediate Visual Acuity (DCIVA; measured at 66 cm) letters on Day 120, hour 3 [Time Frame: Day 1 to Day 120 (Hour 3)]. |
120 Days |
| 4. Mean Change from Baseline in Mesopic Near Vision Presbyopia Task-based Questionnaire (NVPTQ) Performance Score on Day 120, Hour 3. |
120 Days |
| 5. Mean Change from Baseline in Pelli-Robson contrast measurement score on Day 120. |
120 Days |
|
|
Target Sample Size
|
Total Sample Size="206"
Sample Size from India="206"
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 4 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
A Multicenter, Open Label, Single-Arm, Phase IV Clinical Study to
Evaluate the Safety, Tolerability and Efficacy of Pilocarpine
Hydrochloride Ophthalmic Solution USP 1.25 % w/v for the treatment in
Participants with Presbyopia.
Study Objective:
Primary objective: To evaluate the safety and tolerability of Pilocarpine Hydrochloride
ophthalmic solution for the treatment in participants with
presbyopia.
Secondary objectives: To evaluate the efficacy of Pilocarpine Hydrochloride ophthalmic
solution for the treatment in participants with presbyopia.
|