| CTRI Number |
CTRI/2025/10/095572 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Improving Diagnosis and Care for Patients with Dry Eye: A Follow-Up Study |
|
Scientific Title of Study
|
Evaluating Evidence-Based Strategies for the Diagnosis, Subclassification, and
Management of Patients with Dry Eye Disease: A Longitudinal Cohort Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Roy |
| Designation |
Associate Professor |
| Affiliation |
Nethradhama Super speciality eye hospital |
| Address |
256/14,Department of ophthalmology, Block II, II FLOOR Kanakapura Main Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070
818,13TH CROSS, Department of optometry, II floor, Kanakapura Main Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560078
India |
| Phone |
9742536112 |
| Fax |
|
| Email |
viceprincipalnso@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Roy |
| Designation |
Associate Professor |
| Affiliation |
Nethradhama Super speciality eye hospital |
| Address |
256/14,Department of ophthalmology, Block II, II floor Kanakapura Main Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070.
818,Department of Optometry, II floor 13th cross jayanagar 7th block, Jayanagar, Bengaluru, Karnataka 560070.
Bangalore
KARNATAKA
560078
India |
| Phone |
9742536112 |
| Fax |
|
| Email |
viceprincipalnso@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Roy |
| Designation |
Associate Professor |
| Affiliation |
Nethradhama Super speciality eye hospital |
| Address |
. 256/14,Department of ophthalmology, Block II,II floor Kanakapura Main Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560078
India |
| Phone |
9742536112 |
| Fax |
|
| Email |
viceprincipalnso@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama Super Speciality Eye Hospital, Bengaluru, is a NABH-accredited tertiary eye care centre offering services in Cornea, Dry Eye, Cataract, Retina, Glaucoma, and Refractive Surgery. Equipped with advanced diagnostics such as NITBUT, tear meniscus height, meibography, staining, topography, and anterior segment OCT, it provides high-quality care and supports clinical research. |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| RAHUL ROY |
Nethradhama super speciality eye hospital |
256/14, Kanakapura Main Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA |
9742536112
viceprincipalnso@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama Superspeciality Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dry eye Managements |
Participants diagnosed with Dry Eye Disease will receive lubricating eye drops (carboxymethylcellulose 0.5%). The drops will be administered topically in both eyes, one drop 4 times daily (QID). The route of administration is ocular (instillation). The total duration of intervention will be 6 months, with follow-up assessments at baseline, 3 months, and 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 80 years.
Presence of dry eye symptoms (OSDI 6 more than or equal to 4) and at least one clinical sign of DED (NIBUT less than10 secs, TMH less than or equals to 0.20 mm, or mucin lissamine green staining and more than 9 punctate spots).
Willingness to provide informed consent and comply with follow-up visits.
Literate patients can read and complete validated questionnaires (OSDI 6 symptom tools). |
|
| ExclusionCriteria |
| Details |
History of ocular surgery (e.g., refractive or cataract surgery) within the past 12 months.
Active ocular infection or severe ocular surface disease at baseline.
Use of topical ocular medications within 24 hours before baseline evaluation.
Corneal scarring or irregularities interfere with tear film assessment.
Inability or unwillingness to adhere to the follow-up schedule. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome of the study will be the change in the OSDI-6 score from baseline to 3 months and 6
months, providing insight into the improvement or persistence of patient-reported symptoms at baseline 3 months and 6 months. |
At baseline 3 months and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcomes will include changes in objective clinical parameters such as non-invasive tear break-
up time (NITBUT), tear meniscus height (TMH), & ocular surface staining patterns, which together reflect
tear film stability, tear volume, & ocular surface integrity, respectively. Additionally, the study will
3
evaluate the stability of subclassification over the follow-up period to determine whether patients remain in
the same diagnostic category or transition between subtypes. Finally, differences in treatment response will
be analyzed across the various TFOS DEWS III-defined subtypes of dry eye disease, thereby allowing the
identification of subtype-specific therapeutic outcomes & highlighting the need for tailored management
strategies. |
At baseline 3 months & 6 months. |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
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)
|
01/11/2025 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Dry Eye Disease (DED) is a highly prevalent ocular morbidity with multifactorial etiology. Despite available guidelines, diagnosis and management remain inconsistent across clinical settings in India, leading to suboptimal outcomes. A structured, driver-based approach per TFOS DEWS III is required to bridge the gap between evidence-based consensus and real-world clinical practice. |