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CTRI Number  CTRI/2023/02/049510 [Registered on: 07/02/2023] Trial Registered Prospectively
Last Modified On: 23/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To find out effect and safety of polyethylene glycol and sodium hyaluronate in patient with dry eye disease 
Scientific Title of Study   A comparative study of efficacy and safety of polyethylene glycol and sodium hyaluronate in dry eye disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jyoti Kaushal 
Designation  Senior Professor and Head of Department 
Affiliation  Pt.B.D Sharma PGIMS, Rohtak 
Address  3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana
3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana
Rohtak
HARYANA
124001
India 
Phone  9896149454  
Fax    
Email  jyotikaushal65@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Karthick Sekar 
Designation  Post Graduate 
Affiliation  Pt.B.D Sharma PGIMS, Rohtak 
Address  3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana
3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana
Rohtak
HARYANA
124001
India 
Phone  6385306525  
Fax    
Email  karthickronaldo96@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Karthick Sekar 
Designation  Post Graduate 
Affiliation  Pt.B.D Sharma PGIMS, Rohtak 
Address  3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana
3rd floor, Department of Pharmacology, PGIMS, Rohtak Haryana
Rohtak
HARYANA
124001
India 
Phone  6385306525  
Fax    
Email  karthickronaldo96@gmail.com  
 
Source of Monetary or Material Support  
Pt.B.D Sharma PGIMS Rohtak 
 
Primary Sponsor  
Name  Pt BD Sharma PGIMS Rohtak 
Address  PGIMS, Rohtak ,Haryana, 124001 
Type of Sponsor  Government medical college 
 
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 Karthick Sekar  Pt.B.D. Sharma Pgims, rohtak  Room no-10, ground floor Regional institute of OphthalmologyBD Sharma PGIMS Rohtak, Haryana 124001
Rohtak
HARYANA 
6385306525

karthickronaldo96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee Pt.B.D Sharma PGIMS/UHS,Rohtak  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 
Intervention  Polyethlene glycol   Group-A With Polyethylene glycol 0.1% TDS for 6 weeks 
Comparator Agent  Sodium Hyaluronate   Group -B Sodium Hyaluronate 0.1% TDS for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients of either gender > 18 years of age.
Patients diagnosed with moderate dry eye disease (score 9-13) according to Khurana’scoring system.
Patients willing to give written informed consent. 
 
ExclusionCriteria 
Details  Any structural
abnormalities
Pregnant and lactating
women.
Hypertension
Glaucoma.
Diabetes.
History of allergy to
study medication. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Schirmer-1 test
2. Tear break-up time (in seconds)
3. Rose Bengal staining score
4. Goblet cellconjunctivalimpression cytology 
Safety assessment will be carried out for all the treatment groups at 2 and 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Fluorescein staining
2. Lissamine green staining
3. Likert scale using standardized facial expression 
Safety assessment will be carried out for all the treatment groups at 2 and 6 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   14/02/2023 
Date of Study Completion (India) 30/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/11/2023 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Dry eye disease is defined as “a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by an increase in the tear film’s osmolarity and sub-acute ocular surface inflammation." Keratoconjunctivitis sicca(KCS), keratitis sicca, Sicca syndrome, Xeropthalmia, dry eye disease (DED) ocular surface disease (OSD), dysfunctional tear syndrome (DTS). The disruption of the lacrimal functional unit is known to cause dry eye. Lacrimal glands, the ocular surface including cornea, conjunctiva, eyelids, meibomian glands, ocular nerves, and goblet cells make up the lacrimal functional unit. Inclusion criteria - Patients of either gender > 18 years of age, Patients diagnosed with moderate dry eye disease (score 9-13) according to Khurana’s scoring system, and Patients willing to give written informed consent..   Exclusion criteria Patients with Any structural abnormalities, Pregnant and lactating, women,, Hypertension, Glaucoma, Diabetes, History of allergy to study medication. Group A- 25 patients with polyethylene glycol eye drops 0.1% TDS for 6 weeks and Group B- 25 patients with sodium hyaluronate eye drops 0.1%TDS for 6 weeks.Schirmer-1 test ,Tear break-up time, Rose Bengal staining score, Fluorescein staining, Lissamine green staining,(0, 2, and 6 weeks).Goblet cell conjunctival impression cytology ,OSDI (0 and 6 weeks). likert scale and safety assesment  2 and weeks.
 
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