RecruitingPhase 4NCT06939959

Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease.


Sponsor

Khyber Teaching Hospital

Enrollment

126 participants

Start Date

Apr 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a parallel randomized controlled trial for the treatment of dry eye disease. The main objective is to investigate the efficacy and safety of the use of insulin eye drops in the control of moderate-severe dry eye disease. Topical insulin drops will be compared to artificial tears in improving the ocular surface interface in patients with dry eye disease over 1 year period.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patients having Schirmer's test values of less than 10mm after 5 minutes of the procedure recording plus a non-invasive tear breakup time (TBUT) of less than 10 seconds and the Ocular Surface Disease Index (OSDI) of more than 32 (diagnosed as dry eye disease as per the operational definition of this study).
  • any gender.
  • aged 18 years and above.

Exclusion Criteria2

  • Patients with active ocular infection, severe ocular surface disease other than Dry eye disease, and those who have undergone ocular surgery within the past 6 months.
  • Under 18 years old

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Interventions

DRUGArtificial tear

commercially available artificial tears will be used consisting of same ingredients.

DRUGinsulin human

injection humulin will be used to make topical insulin drops


Locations(1)

Khyber Teaching Hospital

Peshawar, Khyber Pukhtunkhwa, Pakistan

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NCT06939959


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