| CTRI Number |
CTRI/2025/09/095395 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Ocular irritation study] |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate ocular irritation of test product on human subjects |
|
Scientific Title of Study
|
Evaluation of the Perceived Discomfort and/or Eye Irritation Potential of Test Product in Adult Human Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250042-US, version_1.0, 20Apr25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat,India -
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat,India -
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Public Query
|
| Name |
Maheshvari Patel |
| Designation |
Director Operations and Strategic Management |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat,India
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Uprising Science Pvt. Ltd |
|
|
Primary Sponsor
|
| Name |
Uprising Science Pvt. Ltd |
| Address |
2nd Floor, Khasra No. 55, Commercial Building,
Hotel Marriott, Ramdas Agrawal Marg,
Near Jawahar Circle Jaipur
Jaipur-302015, Rajasthan
|
| Type of Sponsor |
Other [Hair and skin care manufacturer] |
|
|
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 Nayan Patel |
NovoBliss Research Private Limited |
313, SilverRadiance-4, Gota, Ahmedabad, Gujarat,India - 382481. Ahmadabad GUJARAT382481 India
Ahmadabad
GUJARAT
Ahmadabad
GUJARAT |
07948983895
dr.nayan@novobliss.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACEAS Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The study Participant is in general good health and has both eyes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control |
Tap Water |
| Intervention |
Minimalist Marula Oil 05% Cleansing Oil |
Mode of Usage: Take required quantity of product on fingertips and massage gently on face to remove make-up and dirt Frequency: Once a Day Route of administration: Topical Study duration : 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Participant is in general good health and has both eyes.
2.Understand the test procedures and agree to adhere to study requirements, instructions and procedures.
3.Males and Females (non-pregnant/non-lactating).
4.Ages 18-45 years both inclusive.
5.Females who wears eye makeup.
6.The study general eye evaluation as assessed by trained clinicians.
7.Pass an eye sting evaluation using isotonic saline.
8.Study participants are willing to refrain from using any eye drops on the day of the study.
|
|
| ExclusionCriteria |
| Details |
1.Currently or within the last 2 weeks using eye drops (such as saline solutions, Netra-Prabha, Drasty, etc).
2.Have worn contact lenses during the study period. (12 months).
3.Have any of the following conditions or factors that may affect the interpretation of the test results, including but not limited to, diabetes (controlled or uncontrolled), currently pregnant, or currently lactating or have lactated within the last 4 months.
4.Have participated in a study with the eyes as the target area within 6 weeks of the start of the study.
5.Be participating in any other study concurrently.
6.Be involved in any aspect of study administration, i.e., evaluating applying products, etc.
7.Have a history of sensitivity and/or adverse reactions to preparations intended for the eyes.
8.Ever had any eye conditions such as glaucoma, cataracts, exophthalmos (protuberance of the eye), etc.
9.Subject currently having any eye infections or irritation.
10.The subject is having any sensitivity to eye make-up.
11.Currently have any eye infections or irritation including blepharitis, general lid inflammation, conjunctivitis, or an eye discharge within two weeks of the study.
12.Ever had any eye surgery (including Lasik, laser eye surgery).
13.Currently using any topical medications on the face or any medications intended for the eyes.
14.Consume any alcoholic beverages during the days of the study.
15.Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) or analgesics (including aspirin or other over-the-couter analgesics) on the days of the study.
16.Have any other condition or factor that the Investigator or Ophthalmologist believes may affect the stinging or tearing response or the interpretation of the results.
17.Currently taking any prescription pain medications.
18.Have smoked within 1 hour before each study visit or during the study visit
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the irritation and stinging/discomfort effect of the test product as comparedto control with both subjective sting/irritation and objective evaluations.
2.To assess the visual effect i.e., degree of inflammation of bulbar conjunctiva, palpebralconjunctiva, and lacrimation of test product as compared with the control.
3.To evaluate the effectiveness of the test product in subject perception questionnaire |
Day 01, 07 and 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/10/2025 |
| Date of Study Completion (India) |
14/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
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
|
The
subject will take a test product on their fingertip and then gently massage of
the test product onto the eye area (with the eye closed) for 30 seconds to
simulate the removal of the eye-make up, dirt, sweat etc. The subject will then
be asked to open their eyes and to rate the intensity of perceived
discomfort/irritation using the Stinging/Discomfort Scale. This score will be
recorded on the Test product Evaluation form. The subject will then be asked to
rinse the eye with 6 handfuls of water (which takes about 10 seconds), re-open
the eye, and rate the intensity of discomfort/stinging after rinsing. The
subject will be instructed to continue rinsing the eye using the same procedure
(6 handfuls of water) until the stinging score reaches 0. The water should be
running the entire time during this procedure for emergency
situations. If more than one sink is used, ensure that the water pressure is
consistent in all sinks. After
rinsing each eye, the subjects may gently pat dry each eye, but may not rub the
eye to avoid any irritation. Any remaining eyeliner can be removed after the
subject sees the ophthalmologist for the final evaluation. Once the washing procedure has been completed,
the subject will return to the ophthalmologist-trained evaluator | optometrist
within 5 minutes after completing the wash procedure |