| CTRI Number |
CTRI/2025/05/086765 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
12/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Eye Instillation | Eye Sting |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate ophthalmic safety and/or efficacy of test product on human subjects. |
|
Scientific Title of Study
|
Evaluation and Comparing the Perceived Discomfort and/or Eye Sting Potential of Test Products in Adult Human Subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NB250013-MS |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel MBBS |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India -
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
07948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayan Patel MBBS |
| Designation |
Principal Investigator |
| Affiliation |
NovoBliss Research Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India -
Ahmedabad, Gujarat, India - 382481.
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 Pvt. Ltd. |
| Address |
NovoBliss Research Pvt. Ltd. office 313, Silver Radiance-4, Gota, Ahmedabad, Gujarat, India
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
9909013236 |
| Fax |
|
| Email |
maheshvari@novobliss.in |
|
|
Source of Monetary or Material Support
|
| Yojit Estate, A39,
Wagale Estate, MIDC Landmark,
Near Old Passport Office,
Thane, Maharashtra 400604, India
|
|
|
Primary Sponsor
|
| Name |
Maxima Solutions |
| Address |
Yojit Estate, A39, Road No.11,
Wagale Estate, MIDC Landmark,
Near Old Passport Office,
Thane, Maharashtra 400604, India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Nil |
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 Nayan Patel MBBS |
NovoBliss Research Private Limited |
Clinical Trial Department
office 313, Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India
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 |
| Intervention |
Never Ending Lash Mascara |
Mode of Usage: Apply mascara from the base to the tip of your lashes in a zig-zag motion, focusing on both upper and lower lashes for a complete look.
Frequency: Once a Day
Route of administration: Topical
Study duration : 15 days
|
| Comparator Agent |
Normal Control |
Isotonic Sterile Saline solution OR Distilled Water
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1)Age: 18-65 years (both inclusive) at the time of consent.
2)Sex: Males and non-pregnant/non-lactating females
3)Females with self-reported negative pregnancy test.
4)The study Participant is in general good health and has both eyes.
5)Understand the test procedures and agree to adhere to study requirements, instructions and procedures.
6)Pass a general eye evaluation as assessed by trained clinicians/ophthalmologists.
7)Have visual acuity of at least 20/40, (with corrective wear, i.e. glasses but not contact lens during the study)
8)Pass an eye sting evaluation using isotonic saline.
9)Pass an ophthalmologist eye evaluation as assessed by a consulting ophthalmologist.
10)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 have any allergies or chronic allergies or sensitivities to soaps, shampoos, conditioners, or any other hair products such as detangles as well as fragrances.
14)Currently using any topical medications on the face or any medications intended for the eyes.
15)Be wearing any facial makeup, including false eyelashes, on the day of the study visits.
16)Consume any alcoholic beverages during the days of the study.
17)Have taken antihistamines (including those in cold tablets, OTC allergy medications, decongestants and inhalants) or analgesics (including aspirin or other over-the-counter analgesics) on the days of the study.
18)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.
19)Currently taking any prescription pain medications.
20)Have smoked within 1 hour before each study visit or during the study visit
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To assess the irritation and stinging/discomfort effect of the test product as compared to control with both subjective sting/irritation and objective evaluations.
2.To assess the visual effect i.e., degree of inflammation of bulbar conjunctiva, palpebral conjunctiva, 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
Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/05/2025 |
| Date of Study Completion (India) |
12/06/2025 |
| 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 Yet Recruiting |
| 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
|
Evaluation
and Comparing the Perceived Discomfort and/or Eye Sting Potential of Test
Products in Adult Human Subjects A total of 32
subjects will be enrolled to complete 30 subjects the study. Visit 01 (Day 01) Screening, Enrolment,
Baseline Assessment Visit 02 (Day 02) Test Product Usage
period, end of study |