Corneal Epithelial Wound HealingPhase 4NCT06956846
Efficacy of Topical Insuline in Corneal Epithelial Healing Post PRK
A Phase 4 study testing insulin eye drops and Artificial tears eye-drops in people with Corneal Epithelial Wound Healing, run by Hotel Dieu de France Hospital at 1 site in Lebanon.
Trial summary
A prospective randomized double-blind controlled trial will be conducted. The informed consent of each patient will be obtained prior to the procedure. All patients will undergo a classic PRK procedure Patients will be instructed to use eye drops blindly in both eyes at a frequency of six times daily: In one eye… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Epithelial Wound Healing
- What is being tested?
- insulin eye drops and Artificial tears eye-drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteLebanon
- Study dates
- 25 Apr 2025to Jul 2025
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Myopic or astigmatic patient undergoing excimer laser PRK
Who cannot join
- diabetes mellitus prior ocular surgery ocular surface disease (including dry eye disease, history of herpetic keratitis) previous ocular trauma use of systemic corticosteroids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lebanon1 site
Hotel Dieu de France hospital
Beirut, 166830
Alexandre Schakal, MD, 9613258583, alecschakal@hotmal.com
About this study
Official title: Efficacy of Topical Insuline Drops in Corneal Epithelial Healing Post PRK in Non Diabetic Patients: an Randomized-controlled Trial
A prospective randomized double-blind controlled trial will be conducted. The informed consent of each patient will be obtained prior to the procedure.
All patients will undergo a classic PRK procedure
Read more
Patients will be instructed to use eye drops blindly in both eyes at a frequency of six times daily:
- In one eye: Insulin drops formulated by combining regular human insulin with artificial tears containing polyethylene glycol (PEG 400) 0,25% at a concentration of 1 unit per milliliter.
- In the other eye: Placebo drops containing only artificial tears. For the double-blind trial, two identical vials will be provided to each patient: one labeled R (for the right eye) and one labeled L (for the left eye). Using the bloc randomization method, the pharmacy will be the only entity aware of the composition of each vial, ensuring that 50% of patients use insulin drops in the right eye and 50% in the left eye.
Every week the drops will be prepared one day prior to the PRK procedure and will be stored in a refrigerator, to be used within one week of their preparation date.
Patients will be examined by two ophthalmology residents on days 2 and 4 post-operatively.
The size of the epithelial defect in both eyes will be measured using the ImageJ software. Thus, the primary outcome of the study is the ulceration closure rate: the smaller the defect, the faster the epithelial healing is.
Additionally, a comparison of subjective symptoms reported by the patient in each eye will be recorded.
- Conditions
- Corneal Epithelial Wound Healing
- Being tested
- insulin eye drops, Artificial tears eye-drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin eye dropsDrug
Use of topical insulin eye drops following a standard excimer laser photo-refractive keratecotmy in myopic/astigmatic patients, in order to examine its efficacy in promoting corneal epithelial healing and patient comfort
Artificial tears eye-dropsDrug
The other arm receiving only artificial tears
| Study group | Role | What they receive |
|---|---|---|
| Insulin drops | Active comparator | Eyes receiving eye drops containing human insulin 1U/mL Receives: Drug: insulin eye drops |
| Placebo | Placebo comparator | Eyes only receiving artificial tears Receives: Drug: Artificial tears eye-drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal epithelial healing
Corneal epithelial defect will be measured ar Day 2 and Day 4 using slit images.
Measured: From enrollement to day 4 post PRK
Secondary outcomes (1)
Pain/discomfort
Subjective patient paint/discomfort scores will be recorded and compared ar day 2 and day 4
Measured: day 4 post PRK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start25 Apr 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Corneal Epithelial Wound HealingStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hotel Dieu de France Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956846
- Sponsor's protocol ID
- CEHDF2402
- Status last verified
- Apr 2025
- First submitted
- 25 Apr 2025
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fernandez, MD Alvarado, et al. "3PC-066 Compounding an eye drop formulation of topical insulin for corneal defects refractory to previous treatment: experience in real clinical practice
Serrano-Gimenez R, Contreras-Macias E, Garcia-Bernal A, Fobelo-Lozano MJ. Insulin eye drops for treating corneal ulcer in a non-diabetic patient: regarding a case. Farm Hosp. 2020 Oct 6;44(6):297-299. doi: 10.7399/fh.11521.
PubMed 33156748Diaz-Valle D, Burgos-Blasco B, Gegundez-Fernandez JA, Garcia-Caride S, Puebla-Garcia V, Pena-Urbina P, Benitez-Del-Castillo JM. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280-2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21.
PubMed 32951459Gómez, M. M., Albaladejo, P. M., Sanz, I. R., Crespo, C. B., Durán, J. P., Alemany, A. L., ... & Martí, M. C. (2022). 3PC-020 Chemical stability and physical compatibility of insulin eye drops used in clinical practice.
Castro Mora MP, Palacio Varona J, Perez Riano B, Laverde Cubides C, Rey-Rodriguez DV. Effectiveness of topical insulin for the treatment of surface corneal pathologies. Arch Soc Esp Oftalmol (Engl Ed). 2023 Apr;98(4):220-232. doi: 10.1016/j.oftale.2023.03.007. Epub 2023 Mar 5.
PubMed 36871851Stuard WL, Titone R, Robertson DM. The IGF/Insulin-IGFBP Axis in Corneal Development, Wound Healing, and Disease. Front Endocrinol (Lausanne). 2020 Mar 3;11:24. doi: 10.3389/fendo.2020.00024. eCollection 2020.
PubMed 32194500
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Insuline Drops in Corneal Epithelial Healing Post PRK in Non Diabetic Patients: an Randomized-controlled Trial
- ClinicalTrials.gov ID
- NCT06956846
- Acronym / sponsor ID
- CEHDF2402
- Conditions
- Corneal Epithelial Wound Healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hotel Dieu de France HospitalUniversity, hospital or other
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective randomized double-blind controlled trial will be conducted. The informed consent of each patient will be obtained prior to the procedure.
All patients will undergo a classic PRK procedure
Patients will be instructed to use eye drops blindly in both eyes at a frequency of six times daily:
- In one eye: Insulin drops formulated by combining regular human insulin with artificial tears containing polyethylene glycol (PEG 400) 0,25% at a concentration of 1 unit per milliliter.
- In the other eye: Placebo drops containing only artificial tears. For the double-blind trial, two identical vials will be provided to each patient: one labeled R (for the right eye) and one labeled L (for the left eye). Using the bloc randomization method, the pharmacy will be the only entity aware of the composition of each vial, ensuring that 50% of patients use insulin drops in the right eye and 50% in the left eye.
Every week the drops will be prepared one day prior to the PRK procedure and will be stored in a refrigerator, to be used within one week of their preparation date.
Patients will be examined by two ophthalmology residents on days 2 and 4 post-operatively.
The size of the epithelial defect in both eyes will be measured using the ImageJ software. Thus, the primary outcome of the study is the ulceration closure rate: the smaller the defect, the faster the epithelial healing is.
Additionally, a comparison of subjective symptoms reported by the patient in each eye will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin drops | Active comparator | Drug: insulin eye dropsEyes receiving eye drops containing human insulin 1U/mL |
| Placebo | Placebo comparator | Drug: Artificial tears eye-dropsEyes only receiving artificial tears |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Myopic or astigmatic patient undergoing excimer laser PRK
Key exclusion criteria (1 listed)
- diabetes mellitus prior ocular surgery ocular surface disease (including dry eye disease, history of herpetic keratitis) previous ocular trauma use of systemic corticosteroids
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 |
|---|---|---|
| insulin eye dropsUse of topical insulin eye drops following a standard excimer laser photo-refractive keratecotmy in myopic/astigmatic patients, in order to examine its efficacy in promoting corneal epithelial healing and patient comfort | Drug | Insulin drops |
| Artificial tears eye-dropsThe other arm receiving only artificial tears | Drug | Placebo |
Primary outcome
Corneal epithelial healing
Time frame: From enrollement to day 4 post PRK
Corneal epithelial defect will be measured ar Day 2 and Day 4 using slit images.
1 secondary outcome
Pain/discomfort
Time frame: day 4 post PRK
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- BackgroundFernandez, MD Alvarado, et al. "3PC-066 Compounding an eye drop formulation of topical insulin for corneal defects refractory to previous treatment: experience in real clinical practice
- Background: PubMed 33156748Serrano-Gimenez R, Contreras-Macias E, Garcia-Bernal A, Fobelo-Lozano MJ. Insulin eye drops for treating corneal ulcer in a non-diabetic patient: regarding a case. Farm Hosp. 2020 Oct 6;44(6):297-299. doi: 10.7399/fh.11521.
- Background: PubMed 32951459Diaz-Valle D, Burgos-Blasco B, Gegundez-Fernandez JA, Garcia-Caride S, Puebla-Garcia V, Pena-Urbina P, Benitez-Del-Castillo JM. Topical insulin for refractory persistent corneal epithelial defects. Eur J Ophthalmol. 2021 Sep;31(5):2280-2286. doi: 10.1177/1120672120958307. Epub 2020 Sep 21.
- BackgroundGómez, M. M., Albaladejo, P. M., Sanz, I. R., Crespo, C. B., Durán, J. P., Alemany, A. L., ... & Martí, M. C. (2022). 3PC-020 Chemical stability and physical compatibility of insulin eye drops used in clinical practice.
- Background: PubMed 36871851Castro Mora MP, Palacio Varona J, Perez Riano B, Laverde Cubides C, Rey-Rodriguez DV. Effectiveness of topical insulin for the treatment of surface corneal pathologies. Arch Soc Esp Oftalmol (Engl Ed). 2023 Apr;98(4):220-232. doi: 10.1016/j.oftale.2023.03.007. Epub 2023 Mar 5.
- Background: PubMed 32194500Stuard WL, Titone R, Robertson DM. The IGF/Insulin-IGFBP Axis in Corneal Development, Wound Healing, and Disease. Front Endocrinol (Lausanne). 2020 Mar 3;11:24. doi: 10.3389/fendo.2020.00024. eCollection 2020.
- Individual participant dataSharing planned: No
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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.
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 insulin eye drops and Artificial tears eye-drops in people with Corneal Epithelial Wound Healing, run by Hotel Dieu de France Hospital at 1 site in Lebanon.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 4 May 2025. 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 Lebanon. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elie Raad, MD (96171092022, eliejraad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal epithelial healing (time frame: From enrollement to day 4 post PRK). 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 NCT06956846, which also lists 6 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 4 May 2025.