Corneal Epithelial Wound HealingPhase 2/3NCT07812129
Insulin Eye Drops and Epithelial Healing After Corneal Cross-linking
A Phase 2/3 study testing Insulin eye drops and standard post-operative topical drops in people with Corneal Epithelial Wound Healing and Post Operative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial was to learn if topical insulin eye drops affected corneal epithelial wound healing after corneal collagen cross-linking. The main questions it aimed to answer were: Does topical insulin accelerate corneal epithelial healing after corneal collagen cross-linking? Does it affect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Epithelial Wound Healing, Post Operative Pain
- What is being tested?
- Insulin eye drops and standard post-operative topical drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 30 May 2025
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 above 18 years old diagnosed with bilateral progressive Keratoconus with central corneal thickness more than 400 microns at thinnest location.
Who cannot join
- Patients with signs of infectious keratitis (bacterial, fungal, protozoal or mixed poly-microbial).
- Patients with a history of herpetic keratitis or having diminished corneal sensation.
- Patients with severe dry eye, apical corneal scarring, hydrops, a history of corneal surgery, or ophthalmic disease other than keratoconus.
- Single eyed patients.
- Patients on systemic treatment involving steroids or immune-compromised patients.
- Patients who cannot be monitored with frequent visits as required in the study protocol.
- Pregnant and nursing females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University Faculty of Medicine (Kasr Al Ainy)
Cairo, Al-Manial, 11956
About this study
Official title: The Effect of Topical Insulin Eye Drops On Corneal Epithelial Wound Healing After Corneal Collagen Cross-linking in Keratoconus Management: A Paired-Eye Study
The goal of this clinical trial was to learn if topical insulin eye drops affected corneal epithelial wound healing after corneal collagen cross-linking. The main questions it aimed to answer were:
Does topical insulin accelerate corneal epithelial healing after corneal collagen cross-linking? Does it affect post-operative pain?
Read more
Participants were all diagnosed as having bilateral progressive Keratoconus and were already scheduled for bilateral cross-linking:
Post-operatively, they were asked to apply insulin eye drops in one eye only (4 times daily) in addition to the prescribed routine post-operative treatment which was applied to both eyes.
They were also asked to come for follow-up visits on post-operative day 1,2,3,5 and 7 or until complete corneal wound healing.
The epithelial defect was measured in each eye and the participants were asked to report the degree of pain they felt in each eye at each visit until complete epithelial healing.
- Being tested
- Insulin eye drops, standard post-operative topical drops
- Keywords
- insulin eye drops, topical insulin, corneal epithelial wound healing, paired-eye study, cross-linking, cornea, CXL
- Medical subject headings
- Pain, Postoperative, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin eye dropsDrug
A paired-eye interventional study exploring the effect of insulin eye drops on corneal epithelial wound healing after corneal collagen cross-linking in Keratoconus patients. Each patient served as their own control, where on eye received insulin eye drops post-operatively while the fellow eye (control) didn't.
standard post-operative topical dropsDrug
The standard post-operative treatment prescribed to both eyes included Moxifloxacin 0.5% (Fortymox; Orchidia, Egypt), Tobramycin 0.3% + Dexamethasone 0.1% (Tobradex; Novartis, Switzerland), and a sodium hyaluronate/hydroxypropyl guar tear substitute (Systane Hydration; Alcon, USA), each four times daily.
| Study group | Role | What they receive |
|---|---|---|
| Insulin eye drops | Experimental | After bilateral sequential corneal cross-linking, each patient had one eye randomly assigned to receive insulin eye drops (4 times daily until complete epithelization) in addition to the standard post-operative treatment which was prescribed to both eyes (bandage contact lenses, Moxifloxacin 0.5% eye drops (Fortymox; Orchidia, Egypt), Tobramycin 0.3% + Dexamethasone 0.1% eye drops (Tobradex; Novartis, Switzerland), and a sodium hyaluronate/hydroxypropyl guar tear substitute (Systane Hydration; Alcon, USA), each four times daily).
Insulin eye drops were prepared by adding 10 IU of human insulin (Actrapid; Novo Nordisk, Denmark) to 10 mL of Systane Hydration, yielding a 1 IU/mL solution. Patients were instructed to keep the drops refrigerated.
Randomization was done using a coin toss (heads = right eye, tails = left eye) performed after eligibility confirmation, with allocation concealed using sequentially numbered, sealed envelopes prepared before recruitment. Receives: Drug: Insulin eye drops |
| Standard post-operative treatment only | Active comparator | The other eye (control) of the same patient received the standard post-operative treatment only. This treatment included bandage contact lenses (1-Day Acuvue Moist, -0.25 D; Johnson \& Johnson Vision Care, USA), Moxifloxacin 0.5% eye drops (Fortymox; Orchidia, Egypt), Tobramycin 0.3% + Dexamethasone 0.1% eye drops (Tobradex; Novartis, Switzerland), and a sodium hyaluronate/hydroxypropyl guar tear substitute (Systane Hydration; Alcon, USA), each four times daily. Receives: Drug: standard post-operative topical drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal epithelial wound healing
Patients were examined on post-operative days 1, 2, 3, 5, and 7, or until complete epithelization in both eyes. During these visits, the bandage contact lens were removed and the size of the epithelial defect was measured (guided by fluorescein staining) at its greatest dimension, along two perpendicular axes with a slit lamp micrometer. The healing rate, which is the speed at which the corneal epithelium heals, was assessed. It involved measuring the epithelial defect size changes over time by calculating the percentage of epithelial defect closure: (Original epithelial defect area - Current epithelial defect area)/(Current epithelial defect area) x 100. The percentage was calculated at each visit by the same examiner.
New bandage contact lenses were applied after each examination until complete epithelial healing was achieved.
Measured: 7 days or until complete epithelial healing
Secondary outcomes (1)
Post-operative pain
At each visit, assessment of patient comfort was evaluated for each eye separately by using the Verbal Rating Scale (VRS), which consists of a series of words commonly used to describe pain (0: no pain, 1: mild pain, 2: moderate pain, 3: severe pain, 4: very severe pain, 5: the worst pain ever), the patient was asked to describe the pain in each eye using these words.
Measured: 7 days or until complete epithelial healing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Nov 2023
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal Epithelial Wound HealingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a paired-eye study, patients with bilateral progressive keratoconus were scheduled for corneal collagen cross-linking in both eyes at the same day. Post-operatively, each patient had one eye randomly assigned to receive insulin eye drops in addition to the standard post-operative treatment (antibiotic eye drops 4 times daily, steroid eye drops 4 times daily and preservative free-tear substitutes 4 times daily), while the other eye received the standard treatment alone (control).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar A. El Saadany, Cairo University
- Investigators
- Samar A ElSaadany, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812129
- Sponsor's protocol ID
- MD-436-2023
- Status last verified
- Aug 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Insulin Eye Drops On Corneal Epithelial Wound Healing After Corneal Collagen Cross-linking in Keratoconus Management: A Paired-Eye Study
- ClinicalTrials.gov ID
- NCT07812129
- Acronym / sponsor ID
- MD-436-2023
- Keywords
- insulin eye drops, topical insulin, corneal epithelial wound healing, paired-eye study, cross-linking, cornea, CXL
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 10 Sep 2026 (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.
The goal of this clinical trial was to learn if topical insulin eye drops affected corneal epithelial wound healing after corneal collagen cross-linking. The main questions it aimed to answer were:
Does topical insulin accelerate corneal epithelial healing after corneal collagen cross-linking? Does it affect post-operative pain?
Participants were all diagnosed as having bilateral progressive Keratoconus and were already scheduled for bilateral cross-linking:
Post-operatively, they were asked to apply insulin eye drops in one eye only (4 times daily) in addition to the prescribed routine post-operative treatment which was applied to both eyes.
They were also asked to come for follow-up visits on post-operative day 1,2,3,5 and 7 or until complete corneal wound healing.
The epithelial defect was measured in each eye and the participants were asked to report the degree of pain they felt in each eye at each visit until complete epithelial healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a paired-eye study, patients with bilateral progressive keratoconus were scheduled for corneal collagen cross-linking in both eyes at the same day. Post-operatively, each patient had one eye randomly assigned to receive insulin eye drops in addition to the standard post-operative treatment (antibiotic eye drops 4 times daily, steroid eye drops 4 times daily and preservative free-tear substitutes 4 times daily), while the other eye received the standard treatment alone (control).
| Arm | Type | Receives |
|---|---|---|
| Insulin eye drops | Experimental | Drug: Insulin eye dropsAfter bilateral sequential corneal cross-linking, each patient had one eye randomly assigned to receive insulin eye drops (4 times daily until complete epithelization) in addition to the standard post-operative treatment which was prescribed to both eyes (bandage contact lenses, Moxifloxacin 0.5% eye drops (Fortymox; Orchidia, Egypt), Tobramycin 0.3% + Dexamethasone 0.1% eye drops (Tobradex; Novartis, Switzerland), and a sodium hyaluronate/hydroxypropyl guar tear substitute (Systane Hydration; Alcon, USA), each four times daily). Insulin eye drops were prepared by adding 10 IU of human insulin (Actrapid; Novo Nordisk, Denmark) to 10 mL of Systane Hydration, yielding a 1 IU/mL solution. Patients were instructed to keep the drops refrigerated. Randomization was done using a coin toss (heads = right eye, tails = left eye) performed after eligibility confirmation, with allocation concealed using sequentially numbered, sealed envelopes prepared before recruitment. |
| Standard post-operative treatment only | Active comparator | Drug: standard post-operative topical dropsThe other eye (control) of the same patient received the standard post-operative treatment only. This treatment included bandage contact lenses (1-Day Acuvue Moist, -0.25 D; Johnson \& Johnson Vision Care, USA), Moxifloxacin 0.5% eye drops (Fortymox; Orchidia, Egypt), Tobramycin 0.3% + Dexamethasone 0.1% eye drops (Tobradex; Novartis, Switzerland), and a sodium hyaluronate/hydroxypropyl guar tear substitute (Systane Hydration; Alcon, USA), each four times daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients above 18 years old diagnosed with bilateral progressive Keratoconus with central corneal thickness more than 400 microns at thinnest location.
Key exclusion criteria (7 listed)
- Patients with signs of infectious keratitis (bacterial, fungal, protozoal or mixed poly-microbial).
- Patients with a history of herpetic keratitis or having diminished corneal sensation.
- Patients with severe dry eye, apical corneal scarring, hydrops, a history of corneal surgery, or ophthalmic disease other than keratoconus.
- Single eyed patients.
- Patients on systemic treatment involving steroids or immune-compromised patients.
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 dropsA paired-eye interventional study exploring the effect of insulin eye drops on corneal epithelial wound healing after corneal collagen cross-linking in Keratoconus patients. Each patient served as their own control, where on eye received insulin eye drops post-operatively while the fellow eye (control) didn't. | Drug | Insulin eye drops |
| standard post-operative topical dropsThe standard post-operative treatment prescribed to both eyes included Moxifloxacin 0.5% (Fortymox; Orchidia, Egypt), Tobramycin 0.3% + Dexamethasone 0.1% (Tobradex; Novartis, Switzerland), and a sodium hyaluronate/hydroxypropyl guar tear substitute (Systane Hydration; Alcon, USA), each four times daily. | Drug | Standard post-operative treatment only |
Primary outcome
Corneal epithelial wound healing
Time frame: 7 days or until complete epithelial healing
Patients were examined on post-operative days 1, 2, 3, 5, and 7, or until complete epithelization in both eyes. During these visits, the bandage contact lens were removed and the size of the epithelial defect was measured (guided by fluorescein staining) at its greatest dimension, along two perpendicular axes with a slit lamp micrometer. The healing rate, which is the speed at which the corneal epithelium heals, was assessed. It involved measuring the epithelial defect size changes over time by calculating the percentage of epithelial defect closure: (Original epithelial defect area - Current epithelial defect area)/(Current epithelial defect area) x 100. The percentage was calculated at each visit by the same examiner. New bandage contact lenses were applied after each examination until complete epithelial healing was achieved.
1 secondary outcome
Post-operative pain
Time frame: 7 days or until complete epithelial healing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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. This study is not recruiting at the moment.
Samar A ElSaadany, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Insulin eye drops and standard post-operative topical drops in people with Corneal Epithelial Wound Healing and Post Operative Pain, run by Cairo University at 1 site in Egypt.
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 7 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 10 Sep 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 Egypt. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Corneal epithelial wound healing (time frame: 7 days or until complete epithelial healing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.