Dry EyePhase 4NCT06939959
Topical Insulin for Ocular Surface Interface in Dry Eye Disease
A Phase 4 study testing Artificial tear and insulin human in people with Dry Eye and Insulin Sensitivity, run by Khyber Teaching Hospital at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye, Insulin Sensitivity
- What is being tested?
- Artificial tear and insulin human
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 sitePakistan
- Study dates
- 14 Apr 2025to 25 Apr 2026
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of Topical Insulin for the Restoration of 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.
Read the 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
- Being tested
- Artificial tear, insulin human
- Keywords
- DRY EYE DISEASE, Topical Insulin, Ocular Surface Interface restoration
- Medical subject headings
- Dry Eye Syndromes, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial tearDrug
Also called ARTIFICIAL TEARS
commercially available artificial tears will be used consisting of same ingredients.
insulin humanDrug
Also called INSULIN
injection humulin will be used to make topical insulin drops
| Study group | Role | What they receive |
|---|---|---|
| Artificial Tears | Placebo comparator | Artificial tears Artificial tears 4 times a day Receives: Drug: Artificial tear |
| Topical insulin | Experimental | Experimental: Insulin Topical insulin 1UI/ml 4 times a day Receives: Drug: insulin human |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
.
Measured: Baseline to Week 12
Secondary outcomes (2)
SCHIRMER TEST
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.
Measured: Baseline to Week 12
Tear Film Break up Time
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
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start14 Apr 2025
- Primary completion19 Apr 2026
- Study completion25 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shafiq Tanveer, Khyber Teaching Hospital
- Investigators
- Shafiq Tanvee, MBBS, FCPS, Principal investigator, KHYBER TEACHING HOSPITAL PESHAWAR KPK PAKISTAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939959
- Sponsor's protocol ID
- 579/DME/KMC
- Status last verified
- Aug 2026
- First submitted
- 15 Apr 2025
- Last updated
- 14 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38004570Zhang 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.
PubMed 27213053Aniah 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.
PubMed 31145207Tahmaz 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.
PubMed 38600163Markoulli 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.
PubMed 30802601
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Topical Insulin for the Restoration of Ocular Surface Interface in Dry Eye Disease
- ClinicalTrials.gov ID
- NCT06939959
- Acronym / sponsor ID
- 579/DME/KMC
- Conditions
- Dry Eye, Insulin Sensitivity
- Keywords
- DRY EYE DISEASE, Topical Insulin, Ocular Surface Interface restoration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 19 Apr 2026 (actual)
- Study completion
- 25 Apr 2026 (actual)
- First posted
- 23 Apr 2025 (actual)
- Results
- Posted 14 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Artificial Tears | Placebo comparator | Drug: Artificial tearArtificial tears Artificial tears 4 times a day |
| Topical insulin | Experimental | Drug: insulin humanExperimental: Insulin Topical insulin 1UI/ml 4 times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial tearAlso: ARTIFICIAL TEARScommercially available artificial tears will be used consisting of same ingredients. | Drug | Artificial Tears |
| insulin humanAlso: INSULINinjection humulin will be used to make topical insulin drops | Drug | Topical insulin |
Primary outcome
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. .
2 secondary outcomes
SCHIRMER TEST
Time frame: Baseline to Week 12
Tear Film Break up Time
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38004570Kawahara 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.
- Background: PubMed 27213053Zhang 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.
- Background: PubMed 31145207Aniah 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.
- Background: PubMed 38600163Tahmaz 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.
- Results publication: PubMed 30802601Markoulli 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shafiq Tanvee, MBBS, FCPS principal investigator
KHYBER TEACHING HOSPITAL PESHAWAR KPK PAKISTAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artificial tear and insulin human in people with Dry Eye and Insulin Sensitivity, run by Khyber Teaching Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI Score (time frame: Baseline to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06939959, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.