| CTRI Number |
CTRI/2020/12/029574 [Registered on: 04/12/2020] Trial Registered Prospectively |
| Last Modified On: |
29/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Treatment for aqueous deficiency dry eyes |
|
Scientific Title of Study
|
Intraglandular 5-Fluorouracil injection as a potential lacrimation therapy for aqueous deficient dry eyes: A randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSwati Singh |
| Designation |
Clinical research Ophthalomologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,Room No: 123,GPR Building,1st floor, L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
swatisingh@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSwati Singh |
| Designation |
Clinical research Ophthalomologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,Room No: 123,GPR Building,1st floor, L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
swatisingh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
DrSwati Singh |
| Designation |
Clinical research Ophthalomologist |
| Affiliation |
L V Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,Room No: 123,GPR Building,1st floor,L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
TELANGANA
500034
India |
| Phone |
|
| Fax |
|
| Email |
swatisingh@lvpei.org |
|
|
Source of Monetary or Material Support
|
| L V Prasad Eye Institute, Kallam Anji Reddy Campus,Road No: 2, Banjara Hills, Hyderabad-500034, Telangana |
|
|
Primary Sponsor
|
| Name |
L V Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana. |
| Type of Sponsor |
Other [Non Profitable Organization] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSwati Singh |
L V Prasad Eye Institute |
Kallam Anji Reddy Campus,Room No: 123, GPR Building, 1st floor,L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana. India
Hyderabad
TELANGANA |
7036981646
04023548271
swatisingh@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, L V Prasad Eye Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H041||Other disorders of lacrimal gland, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intra glandular injection of 5- fluorouracil |
2.5mg injected every 4 weeks until there is no further improvement. The injections would continue depending upon the clinical scenario, or if the total dose of 100 mg is achieved or if no change is observed after 3 injections.Preferably no additional topical or systemic therapy would be changed over follow-ups compared to the initiation of therapy.
|
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Age more than 12 years
2) Patients diagnosed with cicatrizing conjunctivitis or Stevens-Johnson syndrome or Ocular cicatricial pemphigoid having Schirmer I value between 1-5mm
3) If both eyes match the criteria, then eye with less Schirmer value would be chosen
4) Only those who choose the injection modality and give a valid consent (attached) will be enrolled into the study.
|
|
| ExclusionCriteria |
| Details |
1) Presence of corneal epithelial defects
2) Schirmer value of zero mm
3) Any ocular surgery within past 3 months
4) Any keratoplasty or ocular surface procedure performed during the trial
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. BCVA
2. Ocular surface disease index
3. Schirmer I value (without anesthesia)
4. Corneal and conjunctival hyperemia
5. Corneal epithelial fluorescein staining
6. Slit lamp images- unstained, fluorescein, green filter
7. Tear sampling for future proteomic study
|
1 and 3 months from the last injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Corneal and conjunctival hyperemia
Corneal epithelial fluorescein staining
Visual acuity |
Monthly for one year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/12/2020 |
| 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="2"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
5-FU has been clinically used in glaucoma filtering surgeries,
recurrent pterygium, and management of ocular surface squamous neoplasias.1,2
5FU induces apoptosis of the Tenon’s fibroblasts and has anti-proliferative
fibroblastic properties. Only one retrospective study (ASOPRS abstract;
unpublished) has shown promising results of 5-FU injections reducing disease
severity in Stevens Johnson syndrome (SJS)/ ocular cicatricial pemphigoid OCP
patients. Lacrimal glands from these patients have demonstrated scarring in the
areas of ductular openings, and preserved acinar structure on histology. Our
initial results of 5-FU injections into the palpebral lobe demonstrated
improvement in Schirmer values with one injection. However, its long-term
effects and number of repeated injections needed are unknown. The aim is to
study the effects of 5-FU on tear secretion in SJS patients in a randomized,
controlled manner. |