Topical Insulin for Ocular Surface Interface in Dry Eye Disease

NCT06939959 | Completed Phase 4 Results DMC

• 1 other identifier: 579/DME/KMC
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye; Insulin Sensitivity

Keywords

DRY EYE DISEASE; Topical Insulin; Ocular Surface Interface restoration

Outcome Measures

Primary Outcomes (1)

• OSDI Score

  The Ocular Surface Disease Index (OSDI) is a 12-item patient-reported questionnaire assessing dry eye symptom severity and its impact on vision-related function. The OSDI score ranges from 0 to 100, with higher scores indicating worse outcomes (greater symptom severity). This outcome reports the continuous OSDI score at baseline, week 4, week 8 and at Week 12 following initiation of treatment. A reduction in OSDI score from baseline indicates improvement in dry eye symptoms. An OSDI score of \<20 at Week 12 was considered the predefined threshold for clinically meaningful symptomatic improvement. .

  Baseline to Week 12

Secondary Outcomes (2)

• SCHIRMER TEST

  Baseline to Week 12

• Tear Film Break up Time

  Baseline to Week 12

Study Arms (2)

Artificial Tears

PLACEBO COMPARATOR

Artificial tears Artificial tears 4 times a day

Drug: Artificial tear

Topical insulin

EXPERIMENTAL

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

Drug: insulin human

Interventions

Artificial tear DRUG

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

Also known as: ARTIFICIAL TEARS

Artificial Tears

insulin human DRUG

injection humulin will be used to make topical insulin drops

Also known as: INSULIN

Topical insulin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Khyber Teaching Hospital: lead

Study Sites (1)

Khyber Teaching Hospital

Peshawar, Khyber Pukhtunkhwa, 25000, Pakistan

Location

Related Publications (5)

• 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.

  PMID: 38004570 BACKGROUND

• 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.

  PMID: 27213053 BACKGROUND

• 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.

  PMID: 31145207 BACKGROUND

• 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.

  PMID: 38600163 BACKGROUND

• 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.

  PMID: 30802601 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes; Insulin Resistance

Interventions

Lubricant Eye Drops; Insulin

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Single-center study. Follow-up time limited to 12 weeks (short follow-up) inflammatory markers were not analysed. subgroup analyses were post-hoc and exploratory which requires cautious interpretation

Results Point of Contact

• Title: Shafiq Tanveer
• Organization: Khyber Teaching Hospital Peshawar

shafaq.tan@gmail.com

+92333 5048601

Study Officials

• Shafiq Tanvee, MBBS, FCPS

  KHYBER TEACHING HOSPITAL PESHAWAR KPK PAKISTAN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Ophthalmologist

Model Details: This will be a randomized controlled trial for the treatment of dry eye disease with two arms: topical artificial tears and topical insulin.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: April 14, 2025
• Primary Completion: April 19, 2026
• Study Completion: April 25, 2026
• Last Updated: August 14, 2026
• Results First Posted: August 14, 2026

Record last verified: 2026-08

Locations

PA (1)