| CTRI Number |
CTRI/2025/09/094545 [Registered on: 10/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluate Efficacy, Safety, and Patient Perception of Drizova eye drops with Mild to Moderate Dry Eye Patients |
|
Scientific Title of Study
|
Evaluate Efficacy, Safety, and Patient Perception of Sodium
Hyaluronate and Trehalose eye drops with Mild to Moderate Dry Eye Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Gautam Parmar |
| Designation |
Head of Department Cornea and refractive surgery department |
| Affiliation |
Sadguru Netra Chikitsalaya |
| Address |
Chitrakoot
Satna
MADHYA PRADESH
210204
India |
| Phone |
9893328485 |
| Fax |
|
| Email |
drgsparmar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Gautam Parmar |
| Designation |
Head of Department Cornea and refractive surgery department |
| Affiliation |
Sadguru Netra Chikitsalaya |
| Address |
Chitrakoot
MADHYA PRADESH
210204
India |
| Phone |
9893328485 |
| Fax |
|
| Email |
drgsparmar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Gopal Sharma |
| Designation |
Lead CRS |
| Affiliation |
Sadguru Netra Chikitsalaya |
| Address |
Clinical Research Secretariat, Chitrakoot
Satna
MADHYA PRADESH
210204
India |
| Phone |
08800787703 |
| Fax |
|
| Email |
gopal@sadgurutrust.org |
|
|
Source of Monetary or Material Support
|
| Sadguru Netra Chikitsalaya, Chitrakoot 210204
|
|
|
Primary Sponsor
|
| Name |
Dr Gautam Parmar |
| Address |
Sadguru Netra Chikitsalaya chitrakoot India- 210204 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gautam Parmar |
sadguru Netra Chikitsalaya, Chitrakoot |
Cornea department, Room No 104
Satna
MADHYA PRADESH |
9893328485
drgsparmar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC sri sadguru Seva Sangh Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Willing to participate in the study and must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study
Male or female Age of above 18 years (completed years) at the time of signing the informed consent.
Patients with an OSDI score between 13 and 22.
Treatment naïve patients
No history of ocular surgery within the last 6 months.
No systemic diseases affecting tear production.
History of allergic reactions to any component of the study medication
Concurrent use of other ocular medications that could interfere with study outcomes
|
|
| ExclusionCriteria |
| Details |
History of allergic reactions to any component of the study medication
Concurrent use of other ocular medications that could interfere with study outcomes
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in OSDI score from baseline |
week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in OSA test ( NIBUT, LLT, TMH, and MG loss) from baseline |
week 4 and 8 |
| Improvemnt in Patient perception score |
week 8 |
| Clinically significant changes in ocular examination |
During study period |
| Incidence and nature of adverse events |
During study period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/09/2025 |
| Date of Study Completion (India) |
10/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This is a Phase 4, open-label, single-arm, single-center, post-marketing study designed to assess the efficacy and safety of Sodium Hyaluronate and Trehalose ophthalmic solution in patients with mild to moderate dry eye disease. The study consists of an 8-week treatment period. In this study, the mean change in OSDI score from baseline to Week 2, Week 4, and Week 8 is determined as the primary efficacy endpoint. The secondary endpoints include mean change in Ocular Surface Analyzer (OSA) parameters—Non-Invasive Tear Break-Up Time (NIBUT), Lipid Layer Thickness (LLT), Tear Meniscus Height (TMH), and Meibomian Gland (MG) loss—from baseline to Week 4 and Week 8, as well as the patient perception score regarding comfort and usability of the eye drops. Safety endpoints include clinically significant changes in ocular examinations and the incidence and nature of adverse events (AEs) observed during the study.
|