| CTRI Number |
CTRI/2025/02/080448 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Experimental Study |
| Study Design |
Other |
|
Public Title of Study
|
Contact Lens solution and ocular pathogen |
|
Scientific Title of Study
|
Effect of Different Multipurpose Contact lens
solution against common Ocular pathogens on
Different Material of Contact lens |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VANDANA KAMATH |
| Designation |
Associate Professor |
| Affiliation |
Sankara college of optometry |
| Address |
Sankara eye hospital Varthur main road Kundalahalli gate Marathahalli
Sankara eye hospital Varthur main road Kundalahalli gate Marathahalli
Bangalore
KARNATAKA
560037
India |
| Phone |
8217690649 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
VANDANA KAMATH |
| Designation |
Associate Professor |
| Affiliation |
Sankara college of optometry |
| Address |
Sankara eye hospital,Varthur mail road
Sankara eye hospital Varthur main road Kundalahalli gate Marathahalli
Bangalore
KARNATAKA
560037
India |
| Phone |
8217690649 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VANDANA KAMATH |
| Designation |
Associate Professor |
| Affiliation |
Sankara college of optometry |
| Address |
Sankara Eye Hospital
Sankara eye hospital Varthur main road Kundalahalli gate Marathahalli
KARNATAKA
560037
India |
| Phone |
8217690649 |
| Fax |
|
| Email |
vandu2388@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital,Varthur main road,Bengaluru |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Mrs Vandana Kamath |
Sankara Eye Hospital, Bangalore, Karnataka |
Varthur Main Road, Kundanahalli Gate, Bangalore - 560037
Bangalore
KARNATAKA |
8217690649
vandu2388@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sankara Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
TRAIL CL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Soft CL
RGP CL |
|
| ExclusionCriteria |
| Details |
Daily soft CL users
Active infection and
inflammation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nil |
Baseline ,1Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Growth of microorganism will be vary depends on the material of contact lens |
baseline, 1 Week |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
27/02/2025 |
| 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="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
SELECTION OF SOFT AND RGP CONTACT LENS BASED ON INCLUSION CRITIRIA, COLLECTION OF MICROORGANISM FROM THE SAMPLES OBTAINED. INOCULATING THE MICROORGANISM ON CONTACT LENS FOR MICROBIAL CULTURE AND INCUBATING IT FOR GROWTH. INTRODUCING THE DIFFERENT MULTIPURPOSE SOLUTION TO THE INOCULATED CONTACT LENS AND OBSERVE THE GROWTH AFTER DISINFECTION |