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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participant Group/Arm | Placebo Comparator | Artificial tears Artificial tears 4 times a day |
|
| Intervention Group/Arm | Experimental | Experimental: Insulin Topical insulin 1UI/ml 4 times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial tear | Drug | commercially available artificial tears will be used consisting of same ingredients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks or 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks or 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shafiq Tanveer, MBBS, FCPS | Contact | +923335048601 | Shafaq.tan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Shafiq Tanvee, MBBS, FCPS | KHYBER TEACHING HOSPITAL PESHAWAR KPK PAKISTAN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Khyber Teaching Hospital | Recruiting | Peshawar | Khyber Pukhtunkhwa | 25000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38004570 | Background | 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. | |
| 27213053 | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 25, 2026 | |
| Reset | May 18, 2026 | |
| Release | Jun 17, 2026 | |
| Reset | Jul 9, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 25, 2026 | May 18, 2026 | |||
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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This will be a randomized controlled trial for the treatment of dry eye disease with two arms: topical artificial tears and topical insulin.
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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.
| insulin human | Drug | injection humulin will be used to make topical insulin drops |
|
|
| 31145207 | 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. |
| 38600163 | 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. |
| 30802601 | Result | 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. |
| Jul 9, 2026 |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D045506 |
| Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |