TO COMPARE THE RESULTS OF USAGE OF TWO PREPARATION OF CYCLOSPORINE EYE DROPS 0.05% (AQUEOUS AND OIL BASED EYE DROPS) IN PATIENTS WITH DRY EYE SYNDROME.

COMPARATIVE EVALUATION OF AQUEOUS BASED AND OIL BASED 0.05% CYCLOSPORINE EYE DROPS IN THE TREATMENT OF MODERATE TO SEVERE DRY EYE DISEASE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/038067

Enrollment

120

Registered

2021-11-16

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

Health Condition 1: H041- Other disorders of lacrimal gland

Interventions

Intervention1: 0.05% CYCLOSPORINE EYE DROPS: GROUP A -ONE DROP OF 0.05% AQUEOUS BASED CYCLOSPORINE EYE DROPS IN BOTH EYE FOR 3 MONTHS Control Intervention1: 0.05% CYCLOSPORINE EYE DROPS: GROUP B - ONE

Eligibility

Inclusion criteria

Inclusion criteria: 1)Aged 18 to 65 years old 2)Moderate to severe DED 3)Tear film break-up time (TBUT) 4)Corneal fluorescein staining (fluorescein staining score of >3 out of 15 in either eye) 5)Schirmer I test 6)OSDI score > 23

Exclusion criteria

Exclusion criteria: 1)History of ocular trauma,active blepharitis, infection, or inflammation not associated with DED during the 3-month period preceding the screening visit 2)Patients with one blind eye 3)Patients with history of active stage of any other concomitant ocular disease 4)Ocular surgery within 3 months preceding the study 5)History of hypersensitivity or any medical condition that contraindicates the use of the study drug or any of its compounds, or derivatives 6)Patients taking any medication, topically or by any other route, which could interfere with the studyâ??s results, in the 3 days prior to trial, or until a time period in which residual effects could be present 7)Contact lens wearer 8)Fertile-age women with an inadequate birth-control method, as well as pregnant or breastfeeding women 9)Legally disqualified or mentally disabled patients who cannot sign an informed consent 10)Patients who cannot comply with medical appointments or with all protocol requirements 11)Patients who disagree to participate in the trial

Design outcomes

Primary

Measure	Time frame
To compare the clinical outcome of aqueous based and oil based 0.05% cyclosporine eye drops in the treatment of moderate to severe dry eye disease. Timepoint: 3 months	—

Secondary

Measure	Time frame
To compare the convenience and tolerability of aqueous based and oil based 0.05% cyclosporine eye drops in the treatment of moderate to severe dry eye disease.Timepoint: 3 months	—

Countries

India

Contacts

Public ContactAYESHA ABDUL SALAM

RPC Centre, AIIMS

ayeshasalam1996@gmail.com8883132218

Outcome results

None listed

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