| CTRI Number |
CTRI/2026/04/107440 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmetics] |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Assessment of Baby Products in Adults |
|
Scientific Title of Study
|
Assessment of Ophthalmologic Safety and Tolerability of Baby Products in Adults |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-MS-189 Version 1.0, dated 12 February 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjula Y M |
| Designation |
Associate Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
BGS Global Institute of Medical Sciences
No. 67, BGS Health & Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9482164779 |
| Fax |
|
| Email |
drmanjulaym.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd. |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Managing Director and CEO |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd. |
| Address |
Department of Clinical Research, No.9, 1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mother Sparsh Baby Care Pvt. Ltd.Plot #. 330, Industrial Area Phase - 1, Panchkula, Haryana-134113 India |
|
|
Primary Sponsor
|
| Name |
Mother Sparsh Baby Care Pvt. Ltd. |
| Address |
Plot #. 330, Industrial Area Phase - 1, Panchkula, Haryana-134113 India |
| Type of Sponsor |
Other [] |
|
|
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 Manjula |
BGS Global Institute of Medical Sciences |
Department of Research Room no 3 BGS Global Institute of Medical Sciences
No 67 BGS Health & Education City Uttarahalli Road Kengeri
Bangalore
KARNATAKA |
9482164779
drmanjulaym.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
With Normal hematological and biochemical parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baby Bathing Bar |
Single instillation of 15 µL of 10% diluted randomized test product in the randomized eye and distilled water in the other eye |
| Intervention |
Baby Shampoo |
Single instillation of 15 µL of 10% diluted randomized test product in the randomized eye and distilled water in the other eye |
| Intervention |
Baby Wash |
Single instillation of 15 µL of 10% diluted randomized test product in the randomized eye and distilled water in the other eye. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with no medical conditions of the eye as determined by the subjects medical history and confirmed by the ophthalmologist.2. Subjects not under any doctors care for or peri orbital diseases.3. Subjects willing to refrain from using any topical facial products, any eye drops, false eyelashes, make-up, over the counter products, or cosmetics on their eyes, eyelids, eyelashes, or the periorbital areas of the face during the study.4.Subjects in good health and willing to provide written informed consent and attend regular follow-up visits.5.Subjects willing to comply with the study protocol and refrain from participating in any other clinical study during the current study. |
|
| ExclusionCriteria |
| Details |
1.Subject with conjunctival, corneal, or periocular conditions, or those using contact lenses. 2.Subject with known history or present allergic condition that may require medical attention. 3.Subject with chronic illness which may influence the cutaneous assessment. 4.Subjects on any systemic medication or with birth defect and anomalies. 5.Subjects with a past or present history of significant ophthalmological disease or conditions, or those judged by the investigator to be inappropriate for this trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Irritation potential as per Ophthalmologist assessment |
0 hour, 30 seconds, 15 minutes, 60 minutes, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in the ocular reaction as per Ophthalmologist assessment on using the test product. |
0 hour, 30 seconds, 15 minutes, 60 minutes, 24 hours |
| Mean change in the ocular irritation severity scores as per subjects assessment on using the test product. |
0 hour, 30 seconds, 15 minutes, 60 minutes, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
07/04/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
This study evaluates the ocular safety and tolerability of the randomized test products. Eligible subjects will be enrolled after consent and medical history review. On visit 1, a single instillation of the diluted test product will be administered in one eye and distilled water in the other eye. Ocular irritation and reaction will be performed at specified time points up to 24 hours. After washout period, the procedure will be repeated for subsequent products. Subjects will attend the scheduled visits and remain at the study site as required for assessments. |