Persistent Corneal Epithelial DefectPhase 4NCT07561398
Comparison of Topical Insulin and Amniotic Membrane Transplant for Persistent Corneal Epithelial Defects
A Phase 4 study testing Topical insulin eye drops and Amniotic Membrane Graft in people with Persistent Corneal Epithelial Defect, run by Al-Shifa Trust Eye Hospital at 1 site in Pakistan.
Trial summary
After an initial period of standard treatment, they received further care aimed at helping the surface of the eye heal. Clear instructions were given on how to use and store the treatment properly. Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistent Corneal Epithelial Defect
- What is being tested?
- Topical insulin eye drops and Amniotic Membrane Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 sitePakistan
- Study dates
- 27 Mar 2026to 27 Sep 2026
- 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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Corneal epithelial defects for more than 2 weeks no improvement using standard treatment
Who cannot join
- • Systemic conditions e.g. uncontrolled Diabetes, autoimmune disorders
- Recent eye surgery within last 3 months
- Hereditary corneal dystrophies
- Active eye infections
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Al Shifa Eye Trust Hospital
Rawalpindi, Punjab Province, 46000
Shama Khan, MBBS,FCPS, +92-3350928355, dr.shamakhan@hotmail.com
About this study
Official title: Comparison of Efficacy of Topical Insulin With Amniotic Membrane Transplant in Persistent Epithelial Defects of Cornea
After an initial period of standard treatment, they received further care aimed at helping the surface of the eye heal. Clear instructions were given on how to use and store the treatment properly. Patients were then monitored regularly over several months, with doctors checking their healing progress during follow-up visits. The study continued for a total of 24 weeks to observe how well and how quickly the eye surface recovered.
Read the detailed description
The area of the corneal epithelial defects will be evaluated using anterior segment photography of the cornea which will be performed after administration of fluorescein dye at a magnification of 10× using a camera attached to a slit-lamp microscope. The images will be analyzed with an image analysis system (ImageJ software) by a single observer to determine the epithelial defect area. The corneal epithelial defect will be graded from I through III. The patients will be randomly divided into two groups using computer generated random number. One half will be treated with Amniotic membrane grafts while other half will receive treatment with topical insulin drops administered every 6 hours till complete re-epithelization of corneal epithelial defects. Follow up will be done uptil 24 weeks.
- Conditions
- Persistent Corneal Epithelial Defect
- Being tested
- Topical insulin eye drops, Amniotic Membrane Graft
- Keywords
- Topical Insulin, Amniotic Membrane graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical insulin eye dropsDrug
Topical Insulin eye drops will be administered every 6 hours till healing of corneal epithelial defects
Amniotic Membrane GraftProcedure or surgery
Surgically amniotic membrane grafts will be applied to bridge and heal the corneal defects
| Study group | Role | What they receive |
|---|---|---|
| Group Topical Insulin | Active comparator | Not described Receives: Drug: Topical insulin eye drops |
| Group Amniotic Membrane graft | Active comparator | Not described Receives: Procedure: Amniotic Membrane Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate
This will be the number of patients out of total number in each group completely cured of corneal epithelial defects
Measured: From time of randomization up to 24th week of followup.
Secondary outcomes (1)
Mean time to healing
This will be the mean time to complete healing in weeks from initiation of treatment until full epithelial closure as confirmed by lack of fluorescein staining on slit-lamp examination.
Measured: From time of randomization upto 24th week of followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start27 Mar 2026
- Primary completion27 Sep 2026 (estimated)
- Study completion27 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Persistent Corneal Epithelial DefectStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Shifa Trust Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subha Masham, Al-Shifa Trust Eye Hospital
- Investigators
- Shama Khan, MBBS,FCPS, Study chair, Senior Consultant Cornea Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561398
- Sponsor's protocol ID
- ERC-42/AST-24
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical Committee doesnt allow data sharing
Publications
Dikmetas O, Kapucu Y, Cankaya AB, Kocabeyoglu S. Outcomes and success of amniotic membrane transplantation for the treatment of corneal diseases. Cutan Ocul Toxicol. 2024 Mar;43(1):33-37. doi: 10.1080/15569527.2023.2275018. Epub 2023 Oct 31.
PubMed 37879107
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Topical Insulin With Amniotic Membrane Transplant in Persistent Epithelial Defects of Cornea
- ClinicalTrials.gov ID
- NCT07561398
- Acronym / sponsor ID
- ERC-42/AST-24
- Conditions
- Persistent Corneal Epithelial Defect
- Keywords
- Topical Insulin, Amniotic Membrane graft
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Al-Shifa Trust Eye HospitalUniversity, hospital or other
- Study start
- 27 Mar 2026 (actual)
- Primary completion
- 27 Sep 2026 (estimated)
- Study completion
- 27 Sep 2026 (estimated)
- First posted
- 1 May 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.
After an initial period of standard treatment, they received further care aimed at helping the surface of the eye heal. Clear instructions were given on how to use and store the treatment properly. Patients were then monitored regularly over several months, with doctors checking their healing progress during follow-up visits. The study continued for a total of 24 weeks to observe how well and how quickly the eye surface recovered.
Detailed description
The area of the corneal epithelial defects will be evaluated using anterior segment photography of the cornea which will be performed after administration of fluorescein dye at a magnification of 10× using a camera attached to a slit-lamp microscope. The images will be analyzed with an image analysis system (ImageJ software) by a single observer to determine the epithelial defect area. The corneal epithelial defect will be graded from I through III. The patients will be randomly divided into two groups using computer generated random number. One half will be treated with Amniotic membrane grafts while other half will receive treatment with topical insulin drops administered every 6 hours till complete re-epithelization of corneal epithelial defects. Follow up will be done uptil 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Topical Insulin | Active comparator | Drug: Topical insulin eye drops |
| Group Amniotic Membrane graft | Active comparator | Procedure: Amniotic Membrane Graft |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Corneal epithelial defects for more than 2 weeks no improvement using standard treatment
Key exclusion criteria (4 listed)
- • Systemic conditions e.g. uncontrolled Diabetes, autoimmune disorders
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 |
|---|---|---|
| Topical insulin eye dropsTopical Insulin eye drops will be administered every 6 hours till healing of corneal epithelial defects | Drug | Group Topical Insulin |
| Amniotic Membrane GraftSurgically amniotic membrane grafts will be applied to bridge and heal the corneal defects | Procedure or surgery | Group Amniotic Membrane graft |
Primary outcome
Cure rate
Time frame: From time of randomization up to 24th week of followup.
This will be the number of patients out of total number in each group completely cured of corneal epithelial defects
1 secondary outcome
Mean time to healing
Time frame: From time of randomization upto 24th week of followup
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 1 May 2026.
- Background: PubMed 37879107Dikmetas O, Kapucu Y, Cankaya AB, Kocabeyoglu S. Outcomes and success of amniotic membrane transplantation for the treatment of corneal diseases. Cutan Ocul Toxicol. 2024 Mar;43(1):33-37. doi: 10.1080/15569527.2023.2275018. Epub 2023 Oct 31.
- Individual participant dataSharing planned: No. Ethical Committee doesnt allow data sharing
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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.
Shama Khan, MBBS,FCPS study chair
Senior Consultant Cornea Department
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 Topical insulin eye drops and Amniotic Membrane Graft in people with Persistent Corneal Epithelial Defect, run by Al-Shifa Trust Eye 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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 May 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. 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 Subha Mashaam Principal Investigator, MBBS (+92-340-6805428, creativedoctor@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate (time frame: From time of randomization up to 24th week of followup.). 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 NCT07561398, which also lists 1 linked publication.
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 1 May 2026.