ClinicalTrials.gg
CompletedNCT07812129Updated Sep 10, 2026

Insulin Eye Drops and Epithelial Healing After Corneal Cross-linking

A Phase 2/3 interventional study of Insulin eye drops and standard post-operative topical drops in Corneal Epithelial Wound Healing and Post Operative Pain, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Cairo University · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Nov 2023, registered Sep 2026).
Phase
Phase 2/3
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 132 studies in Pain, Postoperative by Cairo University — 32 open to participants now, 32 under way, 1 of them phase 3. Pain, Postoperative · Cairo University.

Enrollment
120th of 128
24 · median 50
Started
2023
with 12 others
Phase 2/3
3 of 132
none open now
Registered
130th of 132
by date

Among the 132 studies in Pain, Postoperative by Cairo University, this one is the 120th largest by enrollment of the 128 interventional ones that give a count, is one of 13 that started in 2023, is one of 3 in phase 2/3, and was the 130th registered.

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

Browse Pain, Postoperative studies →

Open to participants now

32 of the 132 studies in Pain, Postoperative by Cairo University are open now, in 1 country. Recruiting first, the newest first:

27 more — sign in →

By country, each count listing its studies:

All 32 open studies →

Where they have run

Who these studies take

Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Corneal Epithelial Wound Healing
  • Post Operative Pain

Keywords

  • insulin eye drops
  • topical insulin
  • corneal epithelial wound healing
  • paired-eye study
  • cross-linking
  • cornea
  • CXL
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

- Patients above 18 years old diagnosed with bilateral progressive Keratoconus with central corneal thickness more than 400 microns at thinnest location.

Exclusion criteria

Exclusion Criteria:

  • 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 or immune-compromised patients.
  • Patients who cannot be monitored with frequent visits as required in the study protocol.
  • Pregnant and nursing females.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Insulin eye drops

    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.

    Drug: Insulin eye drops

  • Active comparator
    Standard post-operative treatment only

    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.

    Drug: standard post-operative topical drops

Interventions

  • 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.

  • Drugstandard post-operative topical drops

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 7 days or until complete epithelial healing

07

Study locations

1 site
  • Cairo University Faculty of Medicine (Kasr Al Ainy)
    Cairo, Al-Manial 11956, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2023 to primary completion in May 2025, 18 months.

Of 49 non-industry phase 2/3 interventional studies under Pain, Postoperative, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's 18 months is close to that.

Counting every sponsor, half of 52 studies reached it within 17 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2026
First posted
Sep 10, 2026
StartActual
Nov 1, 2023
Primary completionActual
May 30, 2025
CompletionActual
May 30, 2025
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07812129
Lead sponsor
Cairo University
Responsible party
Samar A. El Saadany (PhD candidate, Cairo University Faculty of Medicine, Cairo University) — Principal investigator
First posted
Sep 10, 2026
Start date
Nov 1, 2023
Primary completion
May 30, 2025
Completion
May 30, 2025
Last update
Sep 10, 2026

Study contacts

Samar A ElSaadany, MD
principal investigator · Cairo University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Insulin

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