Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorKhyber Teaching Hospital
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Artificial tear
Drugcommercially available artificial tears will be used consisting of same ingredients.
insulin human
Druginjection humulin will be used to make topical insulin drops
Treatment groups
126 Participants
are divided into 2 treatment groupsGroup A: Participant Group/ArmPlacebo comparator 1 intervention
Group B: Intervention Group/ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
OSDI Score
The treatment will be deemed effective if OSDI score of less than 20 is achieved at 12 weeks of the initiation of treatment
Time frame
12 weeks or 3 monthsSecondary outcomes
1
TBUT & SCHIRMER TEST
The treatment will be deemed effective if Schirmer's test values are above 10mm after 5 minutes, TBUT of more than 10 seconds s achieved at 12 weeks of the initiation of treatment.
Time frame
12 weeks or 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov