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

NCT ID: NCT06939959

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-14
• Study Completion Date: 2026-04-20

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.

Conditions

Dry Eye; Insulin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Participant Group/Arm

Artificial tears Artificial tears 4 times a day

Group Type: PLACEBO_COMPARATOR

Artificial tear

Intervention Type: DRUG

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

Intervention Group/Arm

Experimental: Insulin Topical insulin 1UI/ml 4 times a day

Group Type: EXPERIMENTAL

insulin human

Intervention Type: DRUG

injection humulin will be used to make topical insulin drops

Interventions

Artificial tear

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

Intervention Type: DRUG

insulin human

injection humulin will be used to make topical insulin drops

Intervention Type: DRUG

Other Intervention Names

ARTIFICIAL TEARS; HUMULIN INSULIN

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khyber Teaching Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shafiq Tanveer

Resident Ophthalmologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shafiq Tanvee, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

KHYBER TEACHING HOSPITAL PESHAWAR KPK PAKISTAN

Locations

Khyber Teaching Hospital

Peshawar, Khyber Pukhtunkhwa, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Shafiq Tanveer, MBBS, FCPS

Role: CONTACT

Shafaq.tan@gmail.com

+923335048601

Facility Contacts

shafiq Tanveer, MBBS, FCPS

Role: primary

shafaq.tan@gmail.com

+923335048601

References

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.

Reference Type: BACKGROUND

PMID: 38004570 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27213053 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31145207 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 38600163 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30802601 (View on PubMed)

Other Identifiers

579/DME/KMC

Identifier Type: -

Identifier Source: org_study_id