Using insulin eye drops to treat dry eye disease
Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease.
This study is testing whether insulin eye drops can help people with moderate to severe dry eye disease feel better compared to regular artificial tears.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Khyber Teaching Hospital Academic / other |
| Locations | 1 site (Peshawar, Khyber Pukhtunkhwa) |
| Trial ID | NCT06939959 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a parallel randomized controlled trial aimed at evaluating the efficacy and safety of topical insulin eye drops in patients with moderate to severe dry eye disease. Participants will be randomly assigned to receive either insulin eye drops or artificial tears over a one-year period. The study will assess various ocular health metrics, including visual acuity and tear production, to determine the effectiveness of insulin in restoring the ocular surface interface. Data will be collected through structured assessments and examinations at Khyber Teaching Hospital.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diagnosed moderate to severe dry eye disease.
Not a fit: Patients with active ocular infections or severe ocular surface diseases other than dry eye disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel and effective option for patients suffering from dry eye disease.
How similar studies have performed: While the use of topical insulin for ocular conditions is relatively novel, other studies have explored insulin's effects in different contexts, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Peshawar, Khyber Pukhtunkhwa
- Khyber Teaching Hospital — Peshawar, Khyber Pukhtunkhwa, Pakistan (Recruiting)
Study contacts
- Principal investigator: Shafiq Tanvee, MBBS, FCPS — Khyber Teaching Hospital Peshawar Kpk Pakistan
- Study coordinator: Shafiq Tanveer, MBBS, FCPS
- Email: Shafaq.tan@gmail.com
- Phone: +923335048601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.