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CTRI Number  CTRI/2022/03/041175 [Registered on: 17/03/2022] Trial Registered Prospectively
Last Modified On: 10/03/2023
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Eye drops in Indian Subjects to treat dry eye 
Scientific Title of Study   A Phase IV Clinical Trial to Evaluate the Safety and Efficacy of SYSTANE HYDRATION in Indian Subjects with Dry Eye 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
DEN923-P001 protocol version 2 dated 10/12/2020  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Geeta Iyer  
Designation  Senior Consultant  
Affiliation  Sankara Nethralaya (A Unit of Medical Research Foundation) 
Address  41/18 College Road Nungambakkam Chennai

Chennai
TAMIL NADU
600060
India 
Phone    
Fax    
Email  drgeethaiyer@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vardhan Bunga 
Designation  Clinical Trial Lead 
Affiliation  Alcon Laboratories Ind Pvt Ltd  
Address  Godrej Woodsman Estate Rmz Azure (It Complex) 9th 10th and 11th Bellary Rd Hebbal Bengaluru

Bangalore
KARNATAKA
560092
India 
Phone    
Fax    
Email  vardhan.bunga@Alcon.com  
 
Details of Contact Person
Public Query  
Name  Dr Arindam Dey 
Designation  Head- CDMA 
Affiliation  Alcon Laboratories Ind Pvt Ltd  
Address  Godrej Woodsman Estate Rmz Azure (It Complex) 9th 10th and 11th Bellary Rd Hebbal Bengaluru

Bangalore
KARNATAKA
560092
India 
Phone    
Fax    
Email  arindam.dey@Alcon.com  
 
Source of Monetary or Material Support  
Bhagawan Mahavir Jain Hospital, Bangalore  
Dr. shroff charity eye hospital, Delhi 
Medical Research Foundation, A unit of Sankara Nethralaya, Chennai 
Sankara Eye Hospital, Bangalore  
Sponsor 
The Eye foundation, Coimbatore  
 
Primary Sponsor  
Name  Alcon Research Ltd 
Address  6201 South Fwy, Fort Worth, TX 76134, United States 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Alcon Laboratories Ind Pvt Ltd   Godrej Woodsman Estate Rmz Azure (It Complex), 9th, 10th & 11th, Bellary Rd, Hebbal, Bengaluru, Karnataka 560092, India 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rajesh Parekh  Bhagawan Mahavir Jain Hospital  Room number: 1010, Ophthalmology department, ground floor, Millers Road, Vasanthnagar, Banglaore 560062
Bangalore
KARNATAKA 		 09945544744

vision6by6@gmail.com 
Dr Neha Lapur  Dr. Shroff Charity Eye Hospital   Room G05,Cornea OPD, Ground Floor Dr. Shroff Charity Eye Hospital 5027, KEdarnath Lane, Dharyaganj, New DElhi
New Delhi
DELHI 		 09971617296

docneha22@gmail.com 
Dr Umesh Y  Sankara Eye Hospital  Room 29A, Corena Department, Ground Floor, Varthur Main Road, Kundalahalli Main gate, bangalore 560037
Bangalore
KARNATAKA 		 9739000040

umesh@sankaraeye.com 
Dr Geeta Iyer  Sankara Nethralaya  Room number: 6216, C. J. Shah Cornea Services, Dr. G Sitalakshmi Memorial Clinic for Ocular Disorders, Ocular Surfaces Department, 2nd Floor, A.S. Block, JKCN, Sankara Nethralaya(A Unit of Medical Research Foundation), 41/18, College Road, Nungambakam,
Chennai
TAMIL NADU 		 09840293999

drgeethaiyer@gmail.com 
Dr Shreesh Kumar   The Eye Foundation  Room: not applicable, Cornea and refractive service department, First Floor, 582-A, Diwan Bahadur Rd, R.S. Puram, Coimbatore, Tamil Nadu 641002, India
Coimbatore
TAMIL NADU 		 09443317795

sk@theeyefoundation.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Commitee- Dr. Shroff Charity Eye Hospital   Approved 
Institutional Ethics committee- Bhagawan Mahavir Jain Hospital  Approved 
Institutional Ethics Committee- Sankara Eye Hospital   Approved 
The Ethics committee of the Eye Foundation  Approved 
The Institute Ethics Commitee- Vision research foundation   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H049||Disorder of lacrimal system, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable  
Intervention  SYSTANE HYDRATION  Investigational product is a sterile solutions containing sodium hyaluronate (0.15%), polyethylene glycol 400 (0.4%), propylene glycol (0.3%), hydroxypropyl guar 8A, sorbitol, 2-amino 2-methylpropanol, boric acid, sodium borate decahydrate, disodium edetate dihydrate, sodium citrate dihydrate, potassium chloride, sodium chloride, hydrochloric acid, sodium hydroxide, and POLYQUAD (Polyquaternium-1) 0.001% preservative. Investigational Product will be supplied in a DROPTAINERâ„¢ dispenser containing 4-10 mL of solution. The duration of the therapy is for 90 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male or female adults aged >18 years and <65 years of age;
2. Subject must be willing to participate in the study and should understand and sign an informed consent form (ICF) that has been approved by Institutional Review Board (IRB)/ Institutional Ethics Committee (IEC);

3. BCVA of ≥20/40 in each eye as measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) chart;

4. DEQ-5 score ≥6;

5. TBUT ≤10 seconds in both eyes;

6. Average TOSS score ≥4 (based on the 15-point Oxford grading scheme);

7. Subject is otherwise healthy and medically stable on the basis of medical history at screening (based on the investigator’s medical
judgment);

8. Male and female subjects of childbearing potential willing to practice appropriate birth control methods during the entire duration of the study. Appropriate birth control methods include
tubal ligation, transdermal contraceptive patch, intra uterine devices/systems, oral, implantable, or injectable contraceptives, sexual abstinence, double-barrier methods, and vasectomized partner. 
 
ExclusionCriteria 
Details  1. Women of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 1 year) are excluded from participating in the study if they meet any of the following conditions:
a. They are currently pregnant or planning to be pregnant during the study, or
b. They have a positive result on a urine pregnancy test (human chorionic gonadotropin) at the Screening Visit, or
c. They are breast feeding;
2. Contraindications or hypersensitivities to any of the components of the study treatment;
3. Evidence of the following within 30 days prior to the Screening Visit:
a. Ocular infection (bacterial, viral, or fungal)
b. Ocular inflammation including, but not limited to:
i. Inflammation of the anterior or posterior segments
ii. Active allergic conjunctivitis
iii. Active blepharitis or ocular rosacea;
4. Any history of:
a. Trachoma
b. Stevens-Johnson Syndrome
c. Ocular herpes simplex or herpes zoster;
5. Corneal conditions, other than dry eye-related corneal epitheliopathies, affecting the corneal structure including but not limited to:
a. Clinically significant epithelial or endothelial corneal dystrophies.
NOTE: Clinically significant corneal dystrophies are defined as those that affect the central corneal surface (central 5 mm zone) and are associated with the corneal erosion syndrome or
central corneal epithelial microcystic edema which will adversely affect BCVA. Any actively changing or unstable corneal condition; any corneal scar[s] affecting corneal clarity or structure of the cornea or demonstrate an area[s] of concentrated corneal staining.
b. Pterygia that extend >2 mm onto the corneal surface, or any ptyergia that are elevated rather than flat and/or demonstrating significant active inflammation
c. Keratoconus;
6. Ocular surgery (of any type, including photorefractive keratectomy, laser-assisted in situ keratomileusis, epipolis laser in situ keratomileusis [Epilasik], etc.) or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
7. Current presence of punctal plugs (permanent or temporary) or permanent punctal closure by cautery/diathermy are excluded except subjects who are free of punctual occlusion for at least 30 days prior to Screening;
8. Any corneal transplant procedure including penetrating keratoplasty, Descemet’s stripping endothelial keratoplasty, or its variants;
9. Suspected or definite lagophthalmos or history of Bell’s palsy (or other 7th cranial nerve [CN 7] palsy) or any other lid function abnormality (e.g., entropion, ectropion, floppy eyelid syndrome, trichiasis, etc.);
10. Use of any of topical ocular prescription or non-prescription medication, prior to 14 days of screening;
11. Systemic medications known to cause dry eye disease (such as anti-histamines, beta blockers, diuretics, anti-depressants, anti-psychotic medications, and benzodiazepines) which are
newly started or stopped or whose dose has been changed 30 days prior to Screening;
12. Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
13. Subjects with any prior history of artificial
tears/gels/lubricants/rewetting drops use in last 6 weeks;
14. Participation in any other clinical study (device or drug) within 30 days prior to Screening;
15. Any other condition that in the Investigator’s judgment, might interfere with study assessments. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Treatment-emergent AEs
2. TOSS score using Oxford grading scheme collected  		 1. During the study
2. baseline and at 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Dry eye symptoms score will be summarized by using descriptive statistics  at 90 days  
 
Target Sample Size   Total Sample Size="177"
Sample Size from India="177" 
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   Phase 4 
Date of First Enrollment (India)   08/04/2022 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not yet published  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This is a 3-month, open label, prospective, single-arm, multicenter, Phase IV clinical study to evaluate the safety profile and efficacy of SYSTANE(TM) HYDRATION ophthalmic lubricant drops in Indian subjects with dry eye disease. The study will be conducted up to 5 sites in India, and will include approximately 177 subjects aged between 18-65 years to have 150 evaluable subjects.

All study procedures will begin after obtaining written informed consent from the subjects. Subjects will be expected to attend scheduled study visits at Day 1 (Screening and Baseline), and Day 90±5 days (End of Study [EOS]). Telephonic follow-up on Day 30 (±5 days) and Day 75 (±5 days).

All eligible subjects will be dispensed with IP bottles (SYSTANETM HYDRATION Lubricant Eye Drops) sufficient for 90 days’ use at Day 1 and will be instructed to self-administer 1 or 2 drops of IP four times daily in each eye. The first administration of IP will take place at the study site and will be done by the Investigator/qualified study personnel.

 
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