| CTRI Number |
CTRI/2018/04/013133 [Registered on: 10/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
18/10/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparitive study for management of Acanthameba keratitis |
|
Scientific Title of Study
|
A randomized masked clinical trial to assess the efficacy of 1% Voriconazole ophthalmic solution compared to combined use of topical 0.02% Polyhexamethylene biguanide and 0.02% Chlorhexidine ophthalmic solutions in the treatment of Acanthameba keratitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhupesh Bagga |
| Designation |
Consultant, Cornea & Anterior Segment |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
Room No: 610,6th floor
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
Room No; 610, 6th floor
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhupesh Bagga |
| Designation |
Consultant, Cornea & Anterior Segment |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
Room No; 610, 6th floor
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
Room No; 610, 6th floor
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhupesh Bagga |
| Designation |
Consultant, Cornea & Anterior Segment |
| Affiliation |
LV Prasad Eye Institute |
| Address |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
Room No; 610, 6th floor
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
Room No; 610, 6th floor
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
|
| Fax |
|
| Email |
bhupesh@lvpei.org |
|
|
Source of Monetary or Material Support
|
|
|
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 Organisation] |
|
|
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 Bhupesh Bagga |
LV Prasad Eye Institute |
LV Prasad Eye Institute,
Kallam Anji Reddy Campus,
L.V Prasad Marg,
Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana.
Hyderabad
ANDHRA PRADESH |
04030612616
bhupesh@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 |
Acanthameba keratitis , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Polyhexamethylene biguanide and Chlorhexidine |
Ophthalmic Eye drops |
| Intervention |
voriconazole |
Ophthalmic Eye drops |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1) Age equal to or more than 18 years.
2) Male or female
3) Stromal infiltrate size between 2-6 mm.
4) Corneal scraping positive for Acanthamoeba cysts in direct smear examination by any one or more of the methods used.
|
|
| ExclusionCriteria |
| Details |
1) The corneal scrapings are negative for Acanthamoeba.
2) The patient has a history of allergy to voriconazole or chlorhexidine
3) The cornea or sclera has been perforated or perforation is impending.
4) The unaffected eye is legally blind. .
5) The patient is known to be HIV positive or diabetic.
6) The initial culture shows significant growth of bacteria (>10 colonies) or fungus.
7) Both eyes are infected.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment failure – failure to induce a favorable clinical response within two weeks of initiating therapy with either voriconazole or combined therapy. |
2 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to healing, visual acuity change, scar |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "23"
Final Enrollment numbers achieved (India)="23" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/08/2016 |
| Date of Study Completion (India) |
28/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Acanthameba
keratitis (AK) is a rare but potentially devastating amoebic infection of the
cornea. A prevalence of 1.2 per million adults and 0.2 (United States) to 2
(United Kingdom) per 10,000 soft contact lens wearers per year is reported1,2
The increased incidence of Acanthameba keratitis in soft contact
lens wear occurred with the use of
non-sterile contact lens solutions and homemade saline tablets 1The
other causes of increased incidence are reported to contaminated municipal
water supplies 3and
the use of a widely available multipurpose contact lens disinfecting
solution 4 In India, Acanthamoeba is one of the
causative organisms of keratitis with no history
of contact lens usage.5
Currently,
the management of Acanthamoeba
keratitis is diamidines and biguanides which are cysticidal in vitro. Polyhexamethylene biguanide 0.02% (200–600
g/ml) and chlorhexidine 0.2% are used in combination or as single drug therapy with diamidines ( Propamidine isethionate and
hexamidine). 6,7The biguanides interact with the cytoplasmic membrane,
resulting in loss of cellular components and inhibition of respiratory enzymes.
The antimicrobial effects of the diamidines result from the cationic surface
active properties inducing structural membrane changes that affect cell
permeability. When these molecules penetrate into the amoebic cytoplasm,
denaturation of cytoplasmic proteins and enzymes occurs. Propamidine and
hexamidine have been clinically effective against both the trophozoite and cyst
forms of Acanthamoeba. Single drug use of diamidine can lead to
resistance and should not be used as monotherapy. 8 Chlorhexidine has been shown to be
effective against Acanthamoeba.6,9 Oral Voriconazole as
monotherapy has been shown to
be effective in the treatment of refractory AK. 10
Good penetration of topical voriconazole
has been shown in a recent study wherein the aqueous humor concentration was
0.61-3.30 mg/L after one hour of topical administration in fungal keratitis. 11A
strong inhibitory effect upon Acanthamoeba
spp. and N. fowleri at all drug
concentrations through 40 microg/ml has
been reported with voriconazole12.
These studies are either in vitro or reported as case series. 12-14Tu
et al have shown the clinical resolution of AK with oral monotherapy of
Voriconazole. 10
|