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Nano-Tacrolimus and Cyclosporine effect in dry eye

Comparative clinical evaluation of 0.05% Cyclosporine and 0.05% Nano -Tacrolimus eye drops for the treatment of dry eye

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20181006041253N1
Enrollment
24
Registered
2019-01-08
Start date
2018-12-22
Completion date
Unknown
Last updated
2021-06-21

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

Conditions

Dry eye syndrome. Other disorders of lacrimal gland

Interventions

Intervention 1: International group 1: 0.05% nano formulation Tacrolimus drop produced at the Abu Reyhan Pharmacy Company for one eye twice a day, One drop use in the lower conjunctiva for one month.

Sponsors

Birjand University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 78 Years

Inclusion criteria

Inclusion criteria: chronic symptoms of burning, foreign body sensation or itching in both eyes, blurring of vision, photo phobia,and pain daily need for artificial tears The ocular surface disease index (OSDI)=23 tear film break-up time (TBUT) value of 10s or lower Strip Meniscometry test (SM tube) = 10 mm Schirmer test value at 5 min of 10mm or lower

Exclusion criteria

Exclusion criteria: Sensitivity to tacrolimus Pregnancy or lactation Other systemic atopic diseases Previous eye surgery Any structural abnormalities (lid scarring, entropion, trichiasis, etc.) Any inflammation in the anterior chamber Glaucoma Use of other topical drugs, other than artificial tears Use of topical or systemic antibiotics or anti-inflammatory drugs before entering the study Contact lens punctual occlusion

Design outcomes

Primary

MeasureTime frame
Light sensitivity. Timepoint: Before intervention and one month after treatment. Method of measurement: Ocular Surface Disease Index (OSDI).;Blurred vision. Timepoint: Before intervention and one month after treatment. Method of measurement: Ocular Surface Disease Index (OSDI).;Eye irritation. Timepoint: Before intervention and one month after treatment. Method of measurement: Ocular Surface Disease Index (OSDI).;Foreign body sensation. Timepoint: Before intervention and one month after treatment. Method of measurement: Ocular Surface Disease Index (OSDI).;Tear film break up time test (TBUT). Timepoint: Before intervention and one month after treatment. Method of measurement: In seconds, with a timer and slit lamp.;Production of tears. Timepoint: Before intervention and one month after treatment. Method of measurement: Schirmer's test in millimeters.;Tear volume measurement (SM Tube). Timepoint: Before intervention and one month after treatment. Method of measurement: The SM Tube strip is held in the lower lip for 5 seconds. After 5 seconds, the height of the absorbed tear of the blue column is measured.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMozhgan Ahrary

Birjand University of Medical Sciences

mozhganahrarii@gmail.com+98 56 3244 5402

Outcome results

None listed

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