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CTRI Number  CTRI/2021/01/030493 [Registered on: 15/01/2021] Trial Registered Prospectively
Last Modified On: 25/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A prospective, randomized, double-blind, multiple dose, parallel, placebo-controlled, clinical interventional study. 
Scientific Title of Study   A prospective, randomized, double-blind, multiple dose, parallel, placebo-controlled, clinical interventional study of a dietary supplement of OmniActive Health Technologies, India, in adult Subjects with Dry Eye Syndrome (DES) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
G7SYN/P-004/2019; VERSION-01; Dated - 26-06-2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAjay Alexander 
Designation  Medical Monitor 
Affiliation  G7 Synergon Private Limited 
Address  no 537 5th main 9th cross tata nagar sahakaranagar post

Bangalore
KARNATAKA
560092
India 
Phone  08022172700  
Fax    
Email  ajay.alexander@g7synergon.in  
 
Details of Contact Person
Scientific Query  
Name  Dr sathish kumar 
Designation  managing director 
Affiliation  G7 Synergon Private Limited 
Address  no 537 5th main 9th cross tata nagar sahakaranagar post

Bangalore
KARNATAKA
560092
India 
Phone  9677014651  
Fax    
Email  sathishkumar@g7synergon.in  
 
Details of Contact Person
Public Query  
Name  Dr D Sathish Kumar 
Designation  Managing Director 
Affiliation  G7 Synergon Private Limited 
Address  no 537 5th main 9th cross tata nagar sahakaranagar post

Bangalore
KARNATAKA
560092
India 
Phone  9677014651  
Fax    
Email  sathishkumar@g7synergon.in  
 
Source of Monetary or Material Support  
OmniActive Health Technologies Phoenix House, T- 8, A Wing 462 Senapati Bapat Marg, Lower Parel Mumbai 400013  
 
Primary Sponsor  
Name  OmniActive Health Technologies 
Address  Phoenix House T8 A Wing 462 Senapati Bapat Marg Lower Parel Mumbai 400013  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pranav Radkar  Lifepoint Multi specialty Hospital  Clinical research department 145 1 mumbai bangalore highway near hotel sayaji wakad pune 411057 maharashtra india
Pune
MAHARASHTRA 		 9527449733

radkarpranav@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
LPR Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dietary supplement capsules  consume one capsule every morning after the breakfast at the same time every day for 56 days  
Comparator Agent  Placebo  consume one capsule every morning after the breakfast at the same time every day for 56 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and/or female subjects aged between 18 and 65 years (both limits inclusive).
2. Clinical diagnosis of symptomatic Dry Eye Syndrome confirmed, at Baseline by presence of irritation, foreign body (sandy) sensation, feeling of dryness, itching, non-specific ocular discomfort and altered/effected QoL at least in any one of the eye.
3. Subjects shall be in good health and free from any clinically significant disease, other than Dry Eye Syndrome (DES), that might interfere with the study evaluations.
4. Subjects with (at least in any one of the eye)
iv. Schirmer’s Test without anaesthesia ≤ 10 mm.
v. Ocular Surface Disease Index (OSDI) Test symptoms between 12 and 40.
vi. Tear film break up time ≤ 10 seconds
5. Subjects with any of the following (at least in any one of the eye)
iii. Tear Osmolarity ≥ 316 milliosmole /L.
iv. Subjects with Fluorescein corneal staining ≥ 1 and < 3.
6. Subjects must have clinically acceptable results from all the screening laboratory parameters and investigations.
7. Female Subjects of child bearing potential practicing an acceptable method of birth control such as Intrauterine Device in place for at least 3 months prior to the start of the study and remaining in place during the study period, contraceptive transdermal, injection or implants, non-hormonal or hormonal, abstinence; Subjects who shall be practicing abstinence shall agree to have a documented second acceptable method of birth control should the subject become sexually active during the course of her study participation for the duration of the study as judged by the Investigator(s)/study physician and agree to follow the same should be used during treatment.
OR
Postmenopausal for at least 1 year.
OR
Surgically sterile (bilateral tubal ligation/bilateral oophorectomy/ hysterectomy has been performed on the Subject).
8. Subject willing to provide written consent.
9. Subjects shall be willing and able to understand and comply with the requirements of the study, apply the medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
 
 
ExclusionCriteria 
Details  1. Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
2. Subject with positive Urine Pregnancy Test at screening/randomization.
3. History of allergy or sensitivity to Lutein, Zeaxanthin, Curcumin or Vitamin D3, related compounds or any component of the formulation.
4. Presence of severe dry eye syndrome with complications such as perforated Corneal Ulcer, Uveitis and Glaucoma, in the Investigator’s opinion that may interfere with the evaluation of the Subject’s Dry Eye Syndrome (DES).
5. Current evidence of ocular infections or inflammatory conditions like acute conjunctivitis or other medical condition that, in the Investigator’s opinion, would place the Subject at undue risk by participating or compromise the integrity of the study data.
6. Subject with poorly controlled diabetes mellitus, rheumatoid arthritis and Systemic Lupus Erythematosus (SLE) which causes Dry Eye Syndrome.
7. Subjects with herpetic eye disease.
8. Subjects with chronic infection of the lacrimal gland.
9. Subjects with Laser In Situ Keratomileusis (LASIK).
10. Subjects with poorly controlled hypertension (>140/96 mm of Hg).
11. Subjects with evidence of malignancy.
12. Subjects suffering from major systemic illness necessitating long term drug treatment (Psycho-Neuro- Endocrinal disorders, etc.).
13. Subjects with concurrent serious Hepatic Dysfunction or Renal Dysfunction, uncontrolled Pulmonary Dysfunction (asthmatic and Chronic Obstructive Pulmonary Disease (COPD) Subjects) or other concurrent severe disease.
14. Any ocular trauma or surgery that may affect corneal sensitivity and/or normal tear distribution (e.g. cataract surgery, refractive surgery) within the 6 previous months to study inclusion.
15. Subjects willing to stop use of ocular topical medications and contact lens during intervention.
16. Subjects with inability to swallow soft gel capsules.
17. Use of lutein, zeaxanthin, curcumin or vitamin D3 on prescription for other medical indications or for health-conscious reasons.
18. Use of steroids, oral contraceptive pills, estrogen replacement therapy or any other medication that may adversely affect the outcome of the study.
19. Subjects on aspirin or anti-coagulant therapy.
20. Subjects with any other medical condition that might adversely impact the safety of the study participants or confound the study results.
21. Subjects who have been treated with an investigational drug or investigational device within a period of 3 months prior to study entry.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Schirmer’s Test
2.Ocular Surface Disease Index 		 Visit 5 
 
Secondary Outcome  
Outcome  TimePoints 
1. Tear Film Break-Up Time (TBUT)
2. Standard Patient Evaluation of Eye Dryness (SPEED)
3. Corneal and Conjunctival Staining
4. Tear Osmolarity
5. MMP-9 biomarkers
6.Rescue medication usage
 		 Visit 5 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   30/01/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - None of the above

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  Open access

  6. For how long will this data be available start date provided 30-04-2021 and end date provided 30-11-2021?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   A prospective, randomized, double-blind, multiple dose, parallel, placebo-controlled, clinical interventional study of a dietary supplement of OmniActive Health Technologies, India, in adult Subjects with Dry Eye Syndrome (DES).At Visit 2, eligible subjects shall receive sufficient capsules for randomized study product (i.e., Test, or Placebo).
 Subjects shall be instructed to consume one capsule every morning after the breakfast, at the same time every day, for 56 days (8 weeks).  
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