RECRUITINGPhase 4INTERVENTIONAL
Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease.
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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 Criteria:
* 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
Treatments Being Tested
DRUG
Artificial tear
commercially available artificial tears will be used consisting of same ingredients.
DRUG
insulin human
injection humulin will be used to make topical insulin drops
Locations (1)
Khyber Teaching Hospital
Peshawar, Khyber Pukhtunkhwa, Pakistan