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Completed

NCT Number: NCT06939959

Topical Insulin for Ocular Surface Interface in Dry Eye Disease

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Insulin Sensitivity Lacrimal Apparatus Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Khyber Teaching Hospital

Peshawar, Khyber Pukhtunkhwa, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artificial tear

Drug

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

Other names: ARTIFICIAL TEARS

insulin human

Drug

injection humulin will be used to make topical insulin drops

Other names: INSULIN

Primary outcomes

  1. OSDI Score

    Time frame: Baseline to Week 12

    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.

    .

Secondary outcomes

  1. SCHIRMER TEST

    Time frame: Baseline to Week 12

    Schirmer's test (without anaesthesia) measures aqueous tear production as the length of wetting on a standardized 35 mm filter paper strip over 5 minutes, range 0-35 mm. Higher values indicate better outcome (greater tear production)." Unit of Measure: "mm.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.

  2. Tear Film Break up Time

    Time frame: Baseline to Week 12

    Fluorescein tear break-up time (TBUT) measures tear film stability as the time, in seconds, for the first dry spot to appear in the stained tear film after a blink, mean of three readings. Higher values indicate better outcome (more stable tear film). Unit of Measure: seconds Change in Tear Break-Up Time (TBUT) at 12 Weeks

Sponsors and collaborators

Lead sponsor

Khyber Teaching Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2025
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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