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CTRI Number  CTRI/2025/07/091771 [Registered on: 25/07/2025] Trial Registered Prospectively
Last Modified On: 25/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   Using Botox Injections in the Tear Gland to Treat Watery Eyes: A Study to See How Well It Works 
Scientific Title of Study   Evaluating the Effectiveness of Botulinum Toxin Injection into the Lacrimal Gland for Managing Functional Epiphora: A Prospective Interventional Study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Datta 
Designation  Primary DNB Resident 
Affiliation  Centre For Sight Eye Hospital 
Address  First Floor, Exam No. 05, Department Of Oculoplasty, Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi
First Floor, Exam No. 05, Department Of Oculoplasty, Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi
South West
DELHI
110075
India 
Phone  9805993090  
Fax    
Email  divyadatta7311@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Piyush Bajaj 
Designation  Consultant 
Affiliation  Centre For Sight Eye Hospital 
Address  First Floor, Exam No. 05, Department Of Oculoplasty, Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi
First Floor, Exam No. 05, Department Of Oculoplasty, Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi
South West
DELHI
110075
India 
Phone  9958409718  
Fax    
Email  piyushid7@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Piyush Bajaj 
Designation  Consultant 
Affiliation  Centre For Sight Eye Hospital 
Address  First Floor, Exam No. 05, Department Of Oculoplasty, Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi
First Floor, Exam No. 05, Department Of Oculoplasty, Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi
South West
DELHI
110075
India 
Phone  9958409718  
Fax    
Email  piyushid7@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Centre For Sight Eye Hospital 
Address  Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi 110075 
Type of Sponsor  Private hospital/clinic 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Divya Datta  Centre For Sight Eye Institute  First Floor, Exam No. 05, Department Of Oculoplasty, Ophthalmology, Centre For Sight Eye Hospital, Dwarka Sector 09, New Delhi
South West
DELHI 		 9805993090

divyadatta7311@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Centre For Sight Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H042||Epiphora,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BOTOX-A Injection  single dose of 5 IU Injection BOTOX-A Intralacrimally  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Age 18 years and above (Both Males and Females included)

2. Patients diagnosed with Functional epiphora.

3. Presenting with excessive watering with syringing being patent

4. Patients who have given informed consent

5. Willing to complete the treatments and follow up regularly 
 
ExclusionCriteria 
Details  1. Previous hypersensitivity to botulinum toxin or human albumin

2. Eyelid infections like blepharitis, meibomian gland dysfunction.

3. Neuromuscular junction disorders

4. Ocular motility defects

5. Active intraocular inflammation, allergy or infection.

6. Ocular surface infections and inflammations.

7. History of dry eyes

8. Eyelid structural abnormality

9. Pregnancy

10. Lactating mothers 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate the effectiveness of botulinum toxin injection into the lacrimal gland in reducing symptoms of functional epiphora, as measured by changes in the TEARS and MUNK scores.  Baseline, One Month and Three Months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess patient satisfaction and subjective improvement in tearing symptoms following treatment.

To evaluate the duration of effect and time to recurrence of symptoms after injection.

To monitor and document any adverse effects or complications associated with botulinum toxin injections 		 0, 1 and 3 months Follow Up 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 3 
Date of First Enrollment (India)   06/08/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-08-2025 and end date provided 01-12-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study employs a prospective interventional study design, enrolling eligible participants diagnosed with Functional Epiphora. Participants aged 18 and above will be given the Botulinum toxin injection and will be assessed. 
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