| CTRI Number |
CTRI/2023/10/059290 [Registered on: 30/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Other |
|
Public Title of Study
|
To determine the ocular irritation potential of the test product by direct eye-instillation technique |
|
Scientific Title of Study
|
A Human Ocular Instillation study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B03660; Version: 01, Dated 05 Oct 23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Trial Coordinator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot, Off S.G. Highway, Bodakdev, Ahmedabad.
Phone: 91-79-66135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Overall Trial Coordinator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot, Off S.G. Highway, Bodakdev, Ahmedabad.
Phone: 91-79-66135601
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department, Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot, Off S.G. Highway, Bodakdev, Ahmedabad.
Phone: 91-79-66135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Consumer Research Department, Block 17-20, Sigma I Corporates, Opp.
Mann Party Plot, Off S.G. Highway, Bodakdev, Ahmedabad – 380054 |
| Uprising Science Pvt. Ltd.
S-2, Plot No-21, ,Kartarpura Industrial Area,
22 Godam, Jaipur
Rajasthan India- 302006 |
|
|
Primary Sponsor
|
| Name |
Uprising Science Pvt. Ltd. |
| Address |
S-2, Plot No-21, ,Kartarpura Industrial Area,
22 Godam, Jaipur
Rajasthan India- 302006 |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jayadatt Patel |
Balaji Horizon Eye Care |
2nd Floor, Vrundavan Enclave,
AEC Flyover, Beside Shell Petrol Pump,
Naranpura, Ahmedabad, Gujarat 380013.
Ahmadabad
GUJARAT |
07698467875
Balajihorizoneyecare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM – Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy males / non-pregnant and non-lactating females between age group of 18 to 65 years (both inclusive at the time of consent) will be included in the study. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Baby Head To Toe Wash |
10 µl of diluted test product to be instilled into conjunctival sac on one eye.
Single usage of product. |
| Comparator Agent |
Distilled water |
10 µl of control product to be instilled into conjunctival sac on one eye. Single usage of product. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adult non-pregnant/non-lactating females with age 18 to 65 years (both inclusive) at the time of consent.
2. Subjects in general good health as determined by the Investigator on the basis of medical history and with no medical conditions of the eye.
3. Subjects who pass a general eye examination as assessed by Ophthalmologist.
4. Subjects who pass an eye sting evaluation using isotonic saline and an Ophthalmologist Eye evaluation as assessed by Ophthalmologist.
5. Subjects having visual acuity of at least 20/40 (with corrective wear, i.e., glasses but not contact lens). |
|
| ExclusionCriteria |
| Details |
1. Subjects wearing any facial and eye makeup including false eye lashes on the day of the study visits.
2. Subjects currently using or have used eye drops (e.g., Visine, Saline Solutions, etc.) within the last 2 weeks.
3. Subjects who ever had any eye conditions such glaucoma, cataracts, exophthalmos (protuberance of eye), etc.
4. Subjects having any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within 2 weeks of the study.
5. Subjects who had any eye surgery (including Lasik, laser eye surgery).
6. Subjects having any other condition or factor that the Investigator or Ophthalmologist believes may affect the stinging or tearing response or the interpretation of the results.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ophthalmological assessment of Ocular Tolerance of the test product (i.e., degree of inflammation of bulbar and palpebral conjunctiva and lacrimation). |
Day 01 (30 secs, 3 mins, 5 mins, 10 mins, 15 mins and 60 mins after instillation)
Day 02 (24 hrs after instillation) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of self-perceived discomfort using 4-point scale by subjects. |
Day 01 (30 secs, 15 mins and 60 mins after instillation)
Day 02 (24 hrs after instillation)
|
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/11/2023 |
| Date of Study Completion (India) |
07/12/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="2" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a double blinded, randomized, single-arm clinical
study to determine the ocular irritation potential of the test product on
healthy adult human subjects by direct eye-instillation technique.
The study will be conducted in 2 groups: - Group I: 18 enrolled subjects to get at-least 15
completed subjects. - Group II: 18 enrolled subjects to get at-least
15 completed subjects. Initially the study will commence with group I.
Based on the interim analysis of the data of group I and EC Approval of Group I
data, group II study will commence. Both groups will follow the same procedure.
The potential subjects will be screened as per
the inclusion and exclusion criteria only after obtaining written informed
consent from the subjects. Subjects will need to meet the pre-qualification criteria (general
eye examination, visual
acuity test and Ophthalmologist
Eye evaluation) in order to be eligible to participate in the study.
Upon qualification for the study, each subject
will receive one test product and distilled water. The
test product and distilled water will be randomly assigned to the right and
left eye of each subject.
Once product has been applied to both eyes, the
ophthalmologist will evaluate the eye area and the subject will rate their
self-perceived discomfort. |