| 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
|
|
|
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
|
|
|
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. |