Clinical trial NCT06939959: Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease.
Official title: Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Dry Eye
Insulin Sensitivity
Keywords: DRY EYE DISEASE
Topical Insulin
Ocular Surface Interface restoration
Lead sponsor: Khyber Teaching Hospital
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized controlled trial for the treatment of dry eye disease with two arms: topical artificial tears and topical insulin.
Primary purpose: TREATMENT

Brief 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.

Detailed description: Patients fulfilling the selection criteria will be enrolled from eye OPD of KTH. A written informed consent will be taken after explaining the purpose of study. Data will be collected on a pre-designed structured proforma. Demographic data including age, gender, educational status, socioeconomic status will be noted. Each participant will undergo a complete history assessment and the OSDI score will be calculated after taking extensive history. Ophthalmologic examination, including visual acuity, refraction, slit-lamp examination, corneal staining, schirmer test and TBUT will be performed in each patient. Both eyes will be selected for each secondary outcome measure (TBUT \& SCHIRMER TEST). However, only one OSDI score could only be obtained per patient for assessing primary outcome. All the previous medications used for dry eye will be stopped Participants' eyes will be randomized by blocked randomization in a 1:1 ratio to be treated with topical artificial tears (group I) and topical insulin 1U/ml (group II). The patients will be masked for the treatment, but not the principle investigator. Another investigator will prepare the topical insulin according to a written protocol. Participants will be given a white, unlabeled eye dropper containing the same volume of artificial tears or topical insulin for groups I and II respectively. Group I will receive artificial tears (control group) four times daily. Group II will receive topical insulin of 1u/ml four times daily. Follow-up assessments will be conducted at 4, 8 and 12 weeks for each participant to measure changes in TBUT, schirmer test, and OSDI score.

Eligibility 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

Primary outcomes:
measure: OSDI Score
timeFrame: 12 weeks or 3 months
Secondary outcomes:
measure: TBUT & SCHIRMER TEST
timeFrame: 12 weeks or 3 months
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber Teaching Hospital
state: Khyber Pukhtunkhwa
Study officials:
affiliation: KHYBER TEACHING HOSPITAL PESHAWAR KPK PAKISTAN
name: Shafiq Tanvee, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kawahara A. Treatment of Dry Eye Disease (DED) in Asia: Strategies for Short Tear Film Breakup Time-Type DED. Pharmaceutics. 2023 Nov 5;15(11):2591. doi: 10.3390/pharmaceutics15112591.
citation: Zhang X, Zhao L, Deng S, Sun X, Wang N. Dry Eye Syndrome in Patients with Diabetes Mellitus: Prevalence, Etiology, and Clinical Characteristics. J Ophthalmol. 2016;2016:8201053. doi: 10.1155/2016/8201053. Epub 2016 Apr 26.
citation: Aniah Azmi N, Bastion MC. Short-Term Results of Trial of Topical Insulin for Treatment of Dry Eyes in Diabetics. Eye Contact Lens. 2020 Jan;46 Suppl 1:S25-S32. doi: 10.1097/ICL.0000000000000623.
citation: Tahmaz V, Menghesha L, Stern ME, Holtick U, Scheid C, Steven P. Insulin eye drops for severe refractory chronic ocular graft-versus-host disease. Bone Marrow Transplant. 2024 Jul;59(7):1031-1033. doi: 10.1038/s41409-024-02272-9. Epub 2024 Apr 10. No abstract available.
citation: Markoulli M, Hui A. Emerging targets of inflammation and tear secretion in dry eye disease. Drug Discov Today. 2019 Aug;24(8):1427-1432. doi: 10.1016/j.drudis.2019.02.006. Epub 2019 Feb 22.