| CTRI Number |
CTRI/2021/08/035870 [Registered on: 24/08/2021] Trial Registered Prospectively |
| Last Modified On: |
04/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study whether local application of Ultraviolet C radiation along with Methylene Blue eyedrops is beneficial and safe in compared to antimicrobial eye drops in treatment of corneal ulcers |
|
Scientific Title of Study
|
A randomized, open label, single center study to assess the safety and efficacy of Ultraviolet-C rays (4mJ/cm2) plus Methylene Blue eye drops (0.03%) vs standard treatment with antimicrobial drops in treatment for infectious keratitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DJ UVC001 version 1.0 12 Jul 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Uday Gajiwala |
| Designation |
Ophthalmologist |
| Affiliation |
Tejas Eye Hospital |
| Address |
Tejas Eye Hospital, Divyajyoti Trust, Suthar Falia, Opp. Hanuman Temple, At and Po. Mandvi, Dist. Surat, Pin Code: 394160, Gujarat. INDIA.
Surat
GUJARAT
394160
India |
| Phone |
9426125947 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Gajiwala |
| Designation |
Ophthalmologist |
| Affiliation |
Tejas Eye Hospital |
| Address |
Tejas Eye Hospital, Divyajyoti Trust, Suthar Falia, Opp. Hanuman Temple, At and Po. Mandvi, Dist. Surat, Pin Code: 394160, Gujarat. INDIA.
GUJARAT
394160
India |
| Phone |
9426125947 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Gajiwala |
| Designation |
Ophthalmologist |
| Affiliation |
Tejas Eye Hospital |
| Address |
Tejas Eye Hospital, Divyajyoti Trust, Suthar Falia, Opp. Hanuman Temple, At and Po. Mandvi, Dist. Surat, Pin Code: 394160, Gujarat. INDIA.
GUJARAT
394160
India |
| Phone |
9426125947 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Divyajyoti Trust |
| Address |
Divyajyoti Trust, Suthar Falia, Opp. Hanuman temple, Mandvi – 394160, Dist. Surat, Gujarat |
| Type of Sponsor |
Other [Non Governmental 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 |
| Dr Uday Gajiwala |
Tejas Eye Hospital |
Shraddha Office, Ground floor, Netrajyoti Training Center Building, Tejas Eye Hospital,Suthar Falia, Opp. Hanuman Temple, At and Po. Mandvi, Dist. Surat, Pin Code: 394160, Gujarat. INDIA.
Surat
GUJARAT |
9426125947
divyajyoti.icare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC DIVYAJYOTI TRUST TEJAS EYE HOSPITAL |
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 |
| Comparator Agent |
Antimicrobial Eye drops |
Standard topical antimicrobial eye drop therapy recommended for the treatment of microbial keratitis as per the clinical presentation and microbiological reports as per Gram stain, KOH, Culture and Sensitivity for 7 to 14 days |
| Intervention |
Ultraviolet C application and Methylene Blue Eye drops |
A onetime exposure to UVC lamps with output of 4mJ/cm2 for duration of 3 minutes. After exposure of UVC radiation, Methylene blue eye drops 0.03% four times a day will be instilled for minimum10 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects 18 years of age or older.
2. Patient exhibits clinical signs of corneal infiltrate or beginning corneal ulcer in at least one eye of suspected bacterial, fungal, viral or mixed (bacterial and fungal) origin.
3. Infiltrates and early ulcers up to a maximum 6mm in diameter.
4. No previous antibiotic/antifungal/ antiviral at least for a minimum of 48 hours from time of screening.
5. Patient provides voluntary signed and dated informed consent.
6. Patient willing to comply with all study procedures and be available for the duration of the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with bilateral infectious keratitis/corneal ulcers
2. Suspicion of non-infectious keratitis, or acanthamoeba keratitis or sterile infiltrate.
3. Patients who cannot comply in the treatment or be monitored with frequent clinician controls as required in the study protocol. Patient not willing to stay in the hospital for first three days of treatment.
4. Corneal perforation
5. Descemetocele
6. Known or suspected G6PD deficiency
7. Allergic reaction / sensitivity to methylene blue
8. Pregnancy or breastfeeding
9. Immunosuppressed/immune-compromised patients. Patients on corticosteroids by any route for any other disease. Taking anti-inflammatory drugs for any other disease by any route.
10. Taking any antibiotic for any other disease by any route.
11.Patients with diagnosed eczema (or atopic dermatitis)
12. Previous keratoplasty
13. Patients with monocular vision.
14. Subjects with known history of clinically significant gastrointestinal, cardiovascular, hepatic, haematological, renal, respiratory, immunological, and neurological abnormalities, or disease which in opinion of investigator may interfere in the study compliance and assessments.
15. Subjects who have participated in any other clinical trial ≤1 months prior to screening.
16. Subjects who are employees or relatives of the study site staff.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of the time to heal the corneal ulcer in two treatment arms |
Day 7, Day 10, day 14 and Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To gather information on the safety of use of UVC plus Methylene Blue in subjects with Infectious keratitis including severity and frequency of adverse events in the study population. |
Day 7, day 10, day 14, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
30/08/2021 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Will be published once study is completed |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Prospective,
Comparative, Double Arm, Open Label parallel group study comparing application of UVC rays plus Methylene Blue drops with standard of care in patients with
infectious Keratitis.
Patients 18 years
(completed) and above with symptoms and signs of infectious keratitis as
assessed by investigator, who provide consent for participation, and meet the inclusion
criteria and with no exclusion criteria as outlined in the protocol will be
enrolled in the study.
After informed
consent form signature by the subject, data about full clinical history,
physical examination, eye examination, and any current ongoing medications will
be recorded. The eye examinations will include- Slit Lamp Exam &
Fluorescein staining, Corneal Scrapping for microbial tests, Anterior Segment
Optical Coherence Tomography (AS OCT), Pachymetry, specular microscopy, Visual
Acuity. Pain and photophobia shall be assessed by use of a Visual Analogue
Scale (VAS). For all females of childbearing potential, a Urine pregnancy test
will be done.
Eligible patients
will be randomized in a ratio of 1:1 to one of two study arms:
All patients will be
required to stay at the hospital for 72 hrs (3 days) for administration of
study treatments. Subjects will be followed up on Day 3 (Visit 2) before
discharge. Further follow ups will be done on Day 7 (Visit 3), Day 10 (Visit
4), Day 14 (Visit 5) and End of study visit on Day 30 (Visit 6). At each of
these visits Slit lamp examination and fluorescein staining will be done. AS
OCT, and Visual acuity will be repeated at Day 7, Day 10 and Day 14.
At End of study (Day
30) visit, Vital signs will be recorded. Slit lamp and fluorescein staining,
Visual acuity, pachymetry and AS OCT, shall be done. |