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CTRI Number  CTRI/2021/11/037760 [Registered on: 02/11/2021] Trial Registered Prospectively
Last Modified On: 23/12/2024
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 phase III clinical trial study for the treatment of dry eyes and fatigue 
Scientific Title of Study   A prospective open label two arm randomized interventional clinical study to evaluate the efficacy and safety of Maquiday (MAQUIBRIGHT®) for the treatment of dry eyes and fatigue. 
Trial Acronym  MAQU 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
SLS-CT-0005-21-MAQU Version 02 dated 03 Dec 22  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R Senthurselvi  
Designation  Principal investigator 
Affiliation  Spinos Lifescience and Research Pvt Ltd 
Address  Clinical Trial division
29 A Krishna Maduravanam vellakinar Pirivu G N Mills post Coimbatore
Coimbatore
TAMIL NADU
641029
India 
Phone    
Fax    
Email  senthurselvi.r@spinoslifescience.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R Senthurselvi  
Designation  Principal investigator 
Affiliation  Spinos Lifescience and Research Pvt Ltd 
Address  Clinical trial division
29 A Krishna Maduravanam vellakinar Pirivu G N Mills post Coimbatore
Coimbatore
TAMIL NADU
641029
India 
Phone    
Fax    
Email  senthurselvi.r@spinoslifescience.com  
 
Details of Contact Person
Public Query  
Name  Dr R Senthurselvi  
Designation  Principal investigator 
Affiliation  Spinos Lifescience and Research Pvt Ltd 
Address  Clinical Trial division
29 A Krishna Maduravanam vellakinar Pirivu G N Mills post Coimbatore
Coimbatore
TAMIL NADU
641029
India 
Phone    
Fax    
Email  senthurselvi.r@spinoslifescience.com  
 
Source of Monetary or Material Support  
G C Chemie Pharmie Ltd 5/C Shree Laxmi Indl. Estte New Link Road Andheri (West) Mumbai India 
 
Primary Sponsor  
Name  G C Chemie Pharmie Ltd 
Address  5/C Shree Laxmi Indl. Estte New Link Road Andheri (West) Mumbai– 400053 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohit Shetty  Naryana Netralaya Eye Hospital  Cornea and Refractive surgery 121/C, Chord Rd, Near Iskcon Temple, 1st R Block, Rajajinagar, Bengaluru, Karnataka 560010
Bangalore
KARNATAKA 		 9611102568

drrohitshetty@yahoo.com 
Dr Rahul Gaikwad  Orange Hospital  Pawana Nagar Next to Jain School Near Chapekar Chowk Chinchwad
Pune
MAHARASHTRA 		 8983377103

drgaikwadrahul1@gmail.com 
Dr Geeta Iyer  Sankara Nethralaya (Medical Research Foundation)  Cornea Division New no. 41, Old No. 18 College Road, Nugambakkam
Chennai
TAMIL NADU 		 9840293999

drgeethaiyer@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Review Board  Approved 
NARAYANA NETHRALAYA ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H028||Other specified disorders of eyelid,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Maquiday  60 mg Daily once Oral dose Helps in the treatment of patients with inflammatory dry eyes and fatigue 
Comparator Agent  With standard treatment  For treating patients with inflammatory dry eyes and fatigue 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Subjects suffering from dry eyes
Dry eye severity ranging from mild to sever grade 1 to 3 using the DEWS classification
Playing video games use of PCs and or a mobile phone work at VDT for more than or equal to 4 hours per day
Contact lens wearer who can discontinue lenses 24 hours prior to evaluation
Subjects with normal lid position and closure
Subjects willing to stop previous medication for dry eyes during study period
Subjects willing to avoid use of natural eye lubricants on a daily basis but not morethan 6 times a day which has to be documented
Subjects have to avoid the use of natural tears lubricant on the day of Schirmers test
Subjects who have not participated in a similar investigation in the past four weeks
Controlled diabetic patients with HBA1C limit less than 7
If using concomitant medications and the subject condition is stable the subject must agree to remain on a stable dose of his or her concomitant medications throughout the study period or if the subjects condition is not stable then they must agree not to use concomitant medications
Voluntarily participating in the clinical study fully understanding and being fully informed of the study and having signed the Informed Consent Form willingness and capability to complete all the study procedures
 
 
ExclusionCriteria 
Details  Subjects who have used ophthalmic topical or systemic cyclosporine in the past 90 days.
Subjects with Schirmer readings less than 2 mm/5 min without anesthesia in both eyes after stimulation thereby indicating end stage lacrimal gland disease.
Subjects with active ocular infection or ocular inflammation due to autoimmune disease like Sjogrens disease etc
Subjects with lipid-deficient dry eyes like Meibomitis or Meibomian gland disease
Subjects with history of recurrent herpes keratitis or active disease within the last six months.
Subjects with corneal disorder or abnormality that effects corneal sensitivity or normal spreading of the tear film.
Subjects with severe blepharitis or obvious inflammation of the lid margin which in the judgment of the investigator may interfere with the interpretation of the study results.
Subjects who had plug placement (laser, cautery, silicone, or collagen implant) within one month prior to the screening visit
Subjects who use Pilocarpine or antihistamines more than 3 times a week
Subject who have uncontrolled systemic disease (e.g., hypertension, diabetes) or the presence of any significant illness (e.g., serious gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiac, neurologic disease, cancer, AIDS, or cerebral dysfunction) that could in the judgment of the investigator interfere with interpretation of the study results 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
Comparison of length of wetting of the Schrimer’s test strips after five minutes, providing mean value for left/right eye from Baseline to EOT
Improvement in Dry eye condition between both the arms from baseline to EOT by DEQS
Follow up will be done at 70 days +/- 3 days for the well-being of the patient.
 		 70 days 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Comparison of Dry eye Eye fatigue level by VAS between both the arms from baseline to EOT
Comparison of Tear Breakup time test from baseline to EOT between both the arms
Improvement of dry eye symptoms from baseline to Day 30 & Day 30 to EOT between both the arms
Monitoring for adverse events will be done throughout the study period 		 Day 30, 60 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/11/2021 
Date of Study Completion (India) 31/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
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 - NO
Brief Summary   Maqui berry (Aristotelia chilensis) growing in the Patagonia region of Chile is rich in anthocyanins, and has been used as a traditional medicine to treat inflammation since ancient times.  Major anthocyanins contained in maqui berry are delphinidin de-rivatives with potent antioxidant activities. In particular, delphinidin-3,5-O-diglucoside is a specific compound in maqui berries, MaquiBright® also known under the trade name BrightSight® is a maqui berry extract standardized to bear not less than 35% of total anthocyanins and at least 25% of delphinidins.  
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