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Study to compare the effect of Trehalose over sodium hyaluronate in patients of dry eye disease

A prospective, randomized, interventional and comparative open label trial to compare efficacy of Trehalose 3% over sodium hyaluronate 0.1% in patients with dry eye disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024605
Enrollment
375
Registered
2020-04-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: H118- Other specified disorders of conjunctiva

Interventions

Intervention1: Trehalose 3% with 0.1% Sodium hyaluronate Eye drops: One drop 4 times daily for 8 weeks Control Intervention1: 0.1% Sodium Hyaluronate Eye Drops: One drop four times a a day for 8 weeks

Sponsors

Dr Arvind Kumar Morya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Men and non-pregnant/non-lactating women, aged 20-70 years attending Ophthalmic OPD at AIIMS Jodhpur with complaints like dryness, watering, grittiness, burning and hyperemia, who agree to voluntarily participate and give written informed consent, will be enrolled in study to rule out dry eyes by performing schirmerâ??s test, tear film break up time. All those subjects also would be enrolled who have certain systemic risk factors causing dry eye like Sjogrens disease, SLE, chronic drug intake causing dry eyes like antidepressants and antihistamines.

Exclusion criteria

Exclusion criteria: Participants not consenting to take part in the study and with a significant medical/surgical history and on pharmacological treatment, except those specified in inclusion criteria, will be excluded. Patients who were already on dry eye disease and with other eye diseases on topical medications like glaucoma will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
To assess the response to trehalose 3% compared to other lubricating agents in dry eye disease patientsTimepoint: 8 weeks

Secondary

MeasureTime frame
To assess the response to trehalose 3% compared to other lubricating agents in dry eye disease patientsTimepoint: 1 year

Countries

India

Contacts

Public ContactDr Arvind Kumar Morya Phone Fax Email

AIIMS JODHPUR

moryaak@aiimsjodhpurophthalmology.edu.in9812403786

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026