| CTRI Number |
CTRI/2024/02/062387 [Registered on: 07/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study whether adding topical steroid eye drops to the standard of care in acanthamoeba keratitis aids in the healing of the condition |
|
Scientific Title of Study
|
Parasitic Ulcer Treatment Trial (PUTT)
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT06213649 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Venkatesh Prajna |
| Designation |
Chief - Cornea and Refractive Services |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Cornea and Refractive services Department Room No 314
3rd Floor
OPD Block
No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914522530984 |
| Email |
prajna@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Venkatesh Prajna |
| Designation |
Chief - Cornea and Refractive Services |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Cornea and Refractive services Department Room No 314
3rd Floor
OPD Block
No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914522530984 |
| Email |
prajna@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Venkatesh Prajna |
| Designation |
Chief - Cornea and Refractive Services |
| Affiliation |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
| Address |
Cornea and Refractive services Department Room No 314
3rd Floor
OPD Block
No 1 Anna Nagar
Madurai
TAMIL NADU
625020
India |
| Phone |
914524356100 |
| Fax |
914522530984 |
| Email |
prajna@aravind.org |
|
|
Source of Monetary or Material Support
|
| National Institute of Health National Eye Institute
31 Center Dr MSC 2510
Bethesda
MD 20892-2510
USA |
|
|
Primary Sponsor
|
| Name |
National Institute of Health-National Eye Institute |
| Address |
31 Center Dr MSC 2510
Bethesda MD 20892-2510
USA |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Brazil
India
United Kingdom
United States of America |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr N Venkatesh Prajna |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
Cornea and Refractive services Department Room No 314
3rd Floor OPD Block
Madurai
TAMIL NADU |
914524356100
914522530984
prajna@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aravind Eye Hospital, Institutional 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 |
0.1 % dexamethasone in tapering doses for 2 months ( four times a day for first 1 month, two times a day for next 2 weeks and one time a day for last 2 weeks) with 0.08% PHMB four times a day for 2 month |
2 months |
| Comparator Agent |
identical appearing placebo eye drop[artificial tears- 0.5% carboxymethyl cellulose] for 2 months with 0.08% PHMB four times a day for 2 months. |
2 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a) Smear culture PCR Confocal positive Acanthamoeba keratitis
b) Acanthamoeba keratitis patients treated with antiamoebic therapy and have corneal episcleral or anterior chamber inflammation at 4 weeks
c) Appropriate written and informed consent
|
|
| ExclusionCriteria |
| Details |
a) No consent
b) Fungal or Herpetic keratitis
c) Corneal perforation and impending corneal perforation
d) Prior keratoplasty
e) Visual acuity of No light perception in the affected eye
f) Debilitated patient
g) Patients on systemic corticosteroids
h) Corticosteroids allergy
i) Pregnant mothers
j) Steroids responders |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improved 6 month best corrected visual acuity and hasten the time for acanthamoeba keratitis clinical resolution in the steroid group |
4 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the contribution of organism virulence factors and host factors for severe inflammatory outcomes by metagenomic deep sequencing |
4 years |
|
|
Target Sample Size
|
Total Sample Size="232"
Sample Size from India="72"
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)
Modification(s)
|
01/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
12/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Acanthamoeba Keratitis (AK) is an extremely painful, blinding infection requiring long treatment courses. In India, higher incidence of AK has been observed among farmers. Most common mode of injury is mud and contaminated water exposure. The best way to treat AK is entirely unclear. Even with successful antiamoebic treatment, many eyes develop corneal inflammation leading to corneal scarring and poor vision. Use of topical corticosteroids for the treatment of AK is unclear.
In this proposal we seek to establish the safety and efficacy of topical corticosteroids when used alongside anti-amoebic agents and to determine whether any host or pathogen factors can be used to predict the clinical response to steroid therapy by doing Metagenomic deep sequencing (MDS). Aravind Eye Hospital, Madurai, and Proctor Foundation, University of California-San Fransisco, will work in collaboration to better understand these mechanisms and help improve the outcomes of AK patients in the future.
|