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Improving Diagnosis and Care for Patients with Dry Eye: A Follow-Up Study

Evaluating Evidence-Based Strategies for the Diagnosis, Subclassification, and Management of Patients with Dry Eye Disease: A Longitudinal Cohort Study. - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/095572
Enrollment
400
Registered
2025-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H578- Other specified disorders of eye and adnexa

Interventions

Intervention1: Dry eye managements: Dry eye drugs Intervention2: Dry eye Managements: Participants diagnosed with Dry Eye Disease will receive lubricating eye drops (carboxymethylcellulose 0.5%). The

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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).

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.Timepoint: At baseline 3 months and 6 months.

Secondary

MeasureTime frame
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.Timepoint: At baseline 3 months & 6 months.

Countries

India

Contacts

Public ContactRahul Roy

Nethradhama Super speciality eye hospital

viceprincipalnso@gmail.com9742536112

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026