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CTRI Number  CTRI/2022/07/044272 [Registered on: 22/07/2022] Trial Registered Prospectively
Last Modified On: 07/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Eye Sting Test - Direct Eye Instillation Study]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Eye Sting Test and Human Eye Irritation Study 
Scientific Title of Study   Evaluation and Comparing the Perceived Discomfort and/or Eye Sting Potential of Test Products in Adult Human Subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NB220013-GF Version number 01 (Final) 11 Jul 22  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  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar Gujarat - India

Gandhinagar
GUJARAT
382421
India 
Phone  91-9909013286  
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  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar Gujarat - India


GUJARAT
382421
India 
Phone  91-9909013286  
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  Office-A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar Gujarat - India

Gandhinagar
GUJARAT
382421
India 
Phone  91-9909013236  
Fax    
Email  maheshvari@novobliss.in  
 
Source of Monetary or Material Support  
Ginni Filaments Limited, Plot-98, Sector 5, SIDCUL, IIE, Haridwar, Uttarakhand - 249403, India 
 
Primary Sponsor  
Name  Ginni Filaments Limited 
Address  Plot-98, Sector 5, SIDCUL, IIE, Haridwar, Uttarakhand - 249403, India  
Type of Sponsor  Other [FMCG Manufacturer, Distributer, Selling] 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable  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  NovoBliss Research Private Limited  Department - Clinical Trials Office- A - 206, 2nd Floor, Shaligram Lakeview Business Complex, Near Vaishnodevi Circle, Khoraj, Gandhinagar – 382421, Gujarat - India
Gandhinagar
GUJARAT 		 91-9909013286

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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The study participants are in general good health and has both eyes 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BUMTUM Baby Head to Toe Wash   Ten microliters (10µl) of the 10% solution of the test product in distilled water (weigh/weigh) or distilled water based on the study randomization will be placed into the conjunctival sac of the right and left eye.  
Comparator Agent  BUMTUM Baby Shampoo  Ten microliters (10µl) of the 10% solution of the test product in distilled water (weigh/weigh) or distilled water based on the study randomization will be placed into the conjunctival sac of the right and left eye.  
Comparator Agent  Control  Distilled Water 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Age: 18-65 years (both inclusive) at the time of consent.
2)Sex: Males and non-pregnant/non-lactating females (preferably an equal number of males and females).
3) The study Participant is in general good health and has both eyes.
4) Understand the test procedures and agree to adhere to study requirements, instructions and procedures.
5) Pass a general eye evaluation as assessed by trained clinicians/ophthalmologists.
6) Have visual acuity of at least 20/40, (with corrective wear, i.e. glasses but not contact lens)
7) Pass an eye sting evaluation using isotonic saline, and
8) Pass an ophthalmologist eye evaluation as assessed by a consulting ophthalmologist.
9) 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 ever worn contact lenses for the year (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 with in 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   Other 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the irritation and stinging/discomfort effect of the test product as compared to control with both subjective sting/irritation and objective evaluations.

 		 Approximately at 30 seconds (immediate), 15 minutes, and again at approximately 1 hour (60 minutes) after the dosing solutions have been instilled into the eye(s).  
 
Secondary Outcome  
Outcome  TimePoints 
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  Approximately at 30 seconds (immediate), 15 minutes, and again at approximately 1 hour (60 minutes) after the dosing solutions have been instilled into the eye(s).  
To measure the reproducibility of both the subjective scores and objective evaluations by ophthalmologists  Before and After dosing of solutions 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   25/07/2022 
Date of Study Completion (India) 29/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Upon qualification for the study, subjects will participate in the eye sting evaluation of the test product. Each qualified subject will receive one product and the other is distilled water.

After the Ophthalmologist completes his/her initial examination, if the subject qualifies for the study, they will be instructed to sit in an examination chair in a partially reclined position. A study staff member will place his/her thumb or finger on the skin beneath the lower lashes and the adjacent finger on the skin of the upper eyelid and gently spread the lids apart to display the lower conjunctival sac. 


Ten microliters (10µl) of the 10% solution of the test product in distilled water (weigh/weigh) or distilled water based on the study randomization will be placed into the conjunctival sac of the right eye. The staff member will instruct the subject to close her/his eye for a few seconds as he/she removes his/her hand. Once applied, the subject will then rate the stinging of the eye on a 0-3 scale (approximately 30 seconds after application).  

This dosing procedure will be repeated in the left eye with distilled water (based on the randomization) and scored again on a 0-3 scale approximately 30 seconds after instillation for self-perceived discomfort. Once a product has been applied to both eyes, the Ophthalmologist will evaluate the eye area using the scales listed above. These assessments (both Ophthalmologist and self-perceived eye discomfort) will be made approximately at 30 seconds (immediate), 15 minutes, and again at approximately 1 hour (60 minutes) after the dosing solutions have been instilled into the eye(s). 


The Ophthalmologist will also make his/her assessments on a 0-3 scale using a Slit-lamp for evaluations of lacrimation and redness of the bulbar and palpebral conjunctiva.


If a subject rates their eye discomfort at a 2 or 3 at the 60-minute time-point, they will be asked to rinse their eyes (both) with marketed eye wash solution and asked to remain at the test facility for another 15 minutes, at which time the subject will be asked a second time about any eye discomfort. If the subject still reports eye discomfort of a 2 or 3 they will be asked to rinse their eyes (both) a second time with the marketed eye wash solution. The subject will have a final evaluation by the study Ophthalmologist at which time the study Ophthalmologist will determine if it is safe for the subject to leave the facility.

 
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