| CTRI Number |
CTRI/2024/03/064803 [Registered on: 27/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing effect of two antiseptics in the routine management of fungal ulcer
|
|
Scientific Title of Study
|
Comparison of adjuvant 0.02% Chlorhexidine gluconate with 1% Povidone-Iodine in the management of fungal keratitis: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arpita Kulshrestha |
| Designation |
Senior resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Advanced eye centre, Post Graduate Institute of Medical Education & Research
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9958806977 |
| Fax |
|
| Email |
arpita94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Chawla Gupta |
| Designation |
Associate Professor |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
Advanced eye centre, Post Graduate Institute of Medical Education & Research
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9876764629 |
| Fax |
|
| Email |
pcgpgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arpita Kulshrestha |
| Designation |
Senior resident |
| Affiliation |
PGIMER, CHANDIGARH |
| Address |
Advanced eye centre, Post Graduate Institute of Medical Education & Research
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9958806977 |
| Fax |
|
| Email |
arpita94@gmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER, Post Graduate Institute of Medical Education & Research, Chandigarh, 160012
|
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Post Graduate Institute of Medical Education & Research, Chandigarh |
| 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 Arpita Kulshrestha |
Post Graduate Institute of Medical Education & Research |
Advanced Eye centre, Post Graduate Institute of Medical Education & Research, Chandigarh 160012
Chandigarh
CHANDIGARH |
9958806977
arpita94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, PGIMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H160||Corneal ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.02% Chlorhexidine gluconate |
Duration- 3 weeks or till reepithelization, Topical, 6times/ day |
| Intervention |
1% Povidone-Iodine |
Duration- 3 weeks or till reepithelization, Topical administration, 6times/ day |
| Comparator Agent |
Standard antifungal therapy |
Duration- 3 weeks or till reepithelization, Topical administration, Hourly |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Evidence of fungal infection on smear microscopy or in vivo confocal microscopy |
|
| ExclusionCriteria |
| Details |
Ulcers warranting immediate surgical intervention Impending perforation, Perforated ulcer
Mixed OR Bacterial infective keratitis
Endophthalmitis
Previous keratoplasty in affected eye
Known allergy to study medications
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time to ulcer healing |
Day 0, day 3, 7, 14, 21, 60 and 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Best spectacle-corrected visual acuity |
3 months |
| scar size |
3 months |
| infiltrate size and depth |
day 0, day 3, 7, 14, 21, 60 and 90 |
| Time to re-epithelialization |
Time to re-epithelialization |
| Microbiological cure rate |
day 7 |
| Need for therapeutic penetrating keratoplasty |
day 0,3,7,14,21,60, 90 |
| Morphological changes on in vivo confocal microscopy |
day 0, 7, 90 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/02/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
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 - NO
|
|
Brief Summary
|
Patients presenting to Advanced Eye Centre, PGIMER,
Chandigarh, India, with fungal keratitis will receive either standard antifungal therapy
alone or in combination with either 0.02% Chlorhexidine or 1% Povidone-Iodine.
In this study, all participants will receive standard antifungal therapy and therefore will
not cause any hindrance in the appropriate management of the disease. All the patients will be examined and at baseline the size of epithelial defect along with
greatest linear dimension, size in an axis perpendicular to it, the size of stromal
infiltrate and hypopyon, will be evaluated on slit lamp examination.
All the patients whose scraping revealed fungal elements either on KOH mount will be
randomized into three groups:
Group A: Standard antifungal therapy with 1% Povidone- iodine 6 times a day (N=16)
Group B: Standard antifungal therapy with 0.02% chlorhexidine 6 times a day (N=16)
Group C : Standard antifungal therapy (N=16)
Patients will be assessed at baseline, day 3, 7, 14, 21, 60 and 90.
|