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CTRI Number  CTRI/2024/02/063319 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 28/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Assessing the usefulness of Systane COMPLETE eye drops in reducing dry eye problems 
Scientific Title of Study   Assessment of effectiveness of SYSTANE COMPLETE in improving meibomian gland (MG) score and in reducing ocular discomfort symptoms of ocular dryness (Alcon Research, Ltd) 
Trial Acronym  SYSCOM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Namrata Sharma  
Designation  Professor of Ophthalmology 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 495, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS New Delhi

South
DELHI
110029
India 
Phone  011-26593144  
Fax    
Email  namrata.sharma@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Namrata Sharma  
Designation  Professor of Ophthalmology 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 495, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS New Delhi


DELHI
110029
India 
Phone  011-26593144  
Fax    
Email  namrata.sharma@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Namrata Sharma  
Designation  Professor of Ophthalmology 
Affiliation  All India Institute of Medical Sciences 
Address  Room No. 495, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS New Delhi


DELHI
110029
India 
Phone  011-26593144  
Fax    
Email  namrata.sharma@gmail.com  
 
Source of Monetary or Material Support  
Alcon Research, Ltd. 
 
Primary Sponsor  
Name  Alcon Research, Ltd. 
Address  6201 South Freeway Fort Worth, TX 76134‑2001 United States 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 Namrata Sharma  All India Institute of Medical Sciences, New Delhi   Dr Rajendra Prasad center for Ophthalmic Sciences, AIIMS New Delhi,110029
South
DELHI 		 011-26593144

namrata.sharma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H048||Other disorders of lacrimal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  systane complete drops (Propylene Glycol (0.6% w/v))  dosage and frequency : Propylene Glycol (0.6% w/v) frequency - twice a day for 30 days route of administration- topical eye drops 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Subjects ≥ 18years of age both gender
2. Subjects with known case of dry eye disease
3. Best Corrected Visual Acuity (BCVA) of 6/24 [Log MAR equivalent (0.6)] or better
4. Ocular Surface Disease Index (OSDI) : 13 - 33
5. Tear film break-up time (TBUT) ≤ 10 seconds
6. Schirmer tear test (without anesthesia) ≤ 10mm / 5min
7. MGD Score > 20
8. Normal lid position and closure
9. Willingness to sign written informed consent document
 
 
ExclusionCriteria 
Details  1. Any ocular condition that, in the opinion of the Investigator, could affect study parameters. This includes active ocular infection, ocular inflammation, ocular trauma, blepharitis, or, any other condition as deemed by the Investigator.
2. Unwilling to refrain from contact lens use for the entire duration of this study.
3. History of any other ocular surgical procedure within 3 months.
4. Subject with known allergy or hypersensitivity to the components of the formulation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. The mean change in the Ocular surface disease index score (OSDI).
2. The mean change in the MGD scores.
 		 1.baseline and Day 30.
2.baseline and Day 30
 
 
Secondary Outcome  
Outcome  TimePoints 
The mean change in the Non-invasive tear film break-up time (NIBUT)  baseline & Day 30. 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Dry eye disease (DED), a multifactorial disease of the ocular surface, is one of the most common reasons for frequent patient visits to eye care practitioners, affecting an estimated 30 million people in the US. The global prevalence of DED reported in several large studies ranges from 5% to 50%, with meibomian gland dysfunction (MGD) reported in about 70% of dry eye cases. The symptoms and visual disturbances associated with DED have a negative impact on the daily routine and social or quality of life of patients. Therefore, relief from the symptoms of dryness is critical. The treatment goal for DED patients is to improve their ocular comfort by restoring their ocular surface and tear film to a normal state.
PG-HPG nanoemulsion (Systane® Complete [Alcon, Inc., Fort Worth, TX, USA]) lubricant eye drops utilize propylene glycol as the active demulcent with a higher amount of hydroxypropyl guar (HPG) gelling technology than the previous Systane® Balance formulation plus a lipid excipient in smaller nano-sized droplets to optimize the lipid surface coverage with a more translucent appearance. It is intended for patients with dry eye due to either lipid or aqueous deficiency. The unique formulation also contains excipients that can be used in patients with mixed DED. Following the application of PG-HPG nanoemulsion, the HPG/borate meshwork is activated, forming a protective viscoelastic barrier on the surface epithelium. As pH equilibrates and sorbitol is diluted, the viscoelastic HPG meshwork continues to cross-link, maintaining the protective barrier while acting as a depot for the slow release of lipids into the tear film. The anionic phospholipid DMPG (dimyristoyl phosphatidylglycerol) migrates toward the top of the tear film where it fuses with the existing lipids to supplement and stabilize any gaps that have developed due to lipid insufficiency which is caused by MGD. This nanoemulsion formulation restores the complete tear structure to prevent exacerbations of dry eye and maintain a healthier ocular surface.
 
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