| CTRI Number |
CTRI/2021/08/035994 [Registered on: 27/08/2021] Trial Registered Prospectively |
| Last Modified On: |
08/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Collagenase treatment for ocular burns |
|
Scientific Title of Study
|
Safety and efficacy of collagenase application in ocular burns: A prospective open- label academic
randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HERF-CCH-OSB-01, Version 1.1 dated 10 July 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayan Basu |
| Designation |
Director |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Center of Ocular Regeneration (Department), Prof. Brien Holden Eye Research Center (Division),
Room No. 1, 5th Floor GPR Building, LV Prasad Eye Institute, Road No.2 Banjara Hills, Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102511 |
| Fax |
|
| Email |
sayanbasu@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Singh |
| Designation |
Scientist |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Center of Ocular Regeneration (Department), Prof. Brien Holden Eye Research Center (Division), Cabin No.01, 2nd Floor GPR building, LV Prasad Eye Institute, Road No.2 Banjara Hills, Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102286 |
| Fax |
|
| Email |
viveksingh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayan Basu |
| Designation |
Clinician |
| Affiliation |
LV Prasad Eye Institute |
| Address |
Center of Ocular Regeneration (Department), Prof. Brien Holden Eye Research Center (Division), Room No.01, 5th Floor GPR building, LV Prasad Eye Institute, Road No.2 Banjara Hills, Hyderabad
Hyderabad
TELANGANA
500034
India |
| Phone |
04068102511 |
| Fax |
|
| Email |
sayanbasu@lvpei.org |
|
|
Source of Monetary or Material Support
|
| Hyderabad Eye Research Foundation (HERF), 5th Floor GPR building,
LV Prasad Eye Institute, Road No. 2 Banjara Hills, Hyderabad 500034 |
|
|
Primary Sponsor
|
| Name |
Hyderabad Eye Research Foundation |
| Address |
LV Prasad Eye Institute Kallam Anji Reddy Campus Banjara Hills
Hyderbad 500034 Telangana India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Sayan Basu |
LV Prasad Eye Institute |
Suven Clinical
Research, Room No
123, 125 and 127, 1st
floor GPR building, LV Prasad Eye Institute, Kallam Anji
Reddy Campus, Road No. 2, Banjara Hills, Hyderabad 500034
Hyderabad
TELANGANA |
04068102511
sayanbasu@lvpei.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LV Prasad Eye Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H188||Other specified disorders of cornea, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Collagenase |
In the study group
patients receive topical application of collagenase (0.2mg/ml) soaked surgical sponge for 15 mins followed by direct
application of human amniotic
membrane. This is a single dose, one time therapy. |
| Comparator Agent |
Ringers Lactate |
In the control group patients will receive topical application of surgical sponge soaked in ringers lactate solution for 15 mins followed by direct application of human amniotic membrane. This is a single dose, one time therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient should be 18 years and above of age.
2. Patient should be able and prepared to complete all required clincial tests and examinations.
3. Patient should be diagnosed with an acute (<14 days after injury) severe (grade II-IV) unilateral chemical burn.
4. Patient should not have any other ocular abnormality in the injured eye.
5. Able to provide informed consent prior to any study related procedures. |
|
| ExclusionCriteria |
| Details |
1. Unwillingness to participate in the study.
2. Inability to come for all follow-up visits. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of cases showing complete restoration (epithelialization) of the ocular surface on clinical slit-lamp evaluation using fluorescein staining. |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The proportion of patients showing 2-line improvement in BCVA from baseline will be computed along with 95% CIs. |
The secondary end points will be at 3-months, 6-months and 1-year follow up visit. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
31/08/2021 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
We propose to investigate the drug Collagenase in a prospective open-label randomized controlled academic clinical trial. In particular, we aim at evaluating the safety and efficacy of topical collagenase for the treatment of adult patients with acute severe unilateral chemical burns. This trial will be single centre, performed at the LV Prasad Eye Institute (LVPEI), in Hyderabad, India. |