Corneal Epithelial Wound HealingPhase 2NCT06854393
Lacripep for Corneal Wound Healing Study
A Phase 2 study of Corneal Epithelial Wound Healing, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
The objective of this study is to evaluate the safety and effectiveness of Lacripep as a therapy for superficial corneal injury repair after Photorefractive keratectomy (PRK). Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Corneal Epithelial Wound Healing
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2025to Sep 2027
- Phase
- Phase 2
- 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 21 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female, of any race, 21 years old and older
- Active-duty U.S. military service members or their dependents eligible for care at Alexander T. Augusta Military Medical Center for 6-month period postoperatively
- Desiring refractive correction of myopia up to -4.00 diopters (D) sphere with or without astigmatism 0 to -1.50 D and up to -4.00 D manifest spherical equivalent in both eyes
- Stable refraction for the past year as demonstrated by a change in manifest refractive spherical equivalent of ≤ 0.50 diopters (D) in both eyes
- CDVA of at least 20/20 in both eyes
- Elected to undergo bilateral PRK
- Able to meet follow up requirements for up to 6-month period post-operatively
Who cannot join
- Calculated ablation depth of greater than 75 microns or other conditions in either eye which in the judgement of the investigators will require use of prophylactic MMC
- Signs of unstable or progressive myopia, keratoconus or keratoconus suspect in either eye
- Abnormal corneal topographic findings in either eye e.g., keratoconus, pellucid marginal degeneration
- Treatment targeted for monovision
- Signs and symptoms of dry eye based on: (a) Corneal fluorescein staining total score ≥4 in the National Eye Institute (NEI)/Industry Workshop scale in either eye, (b) Anethetized Schirmer test score ≤5 mm/5 minutes in either eye, (c) Symptom score ≤40 using the Symptom Assessment in Dry Eye (SANDE) questionnaire in either eye
- Female subjects who are pregnant, breastfeeding or intend to become pregnant during the study. Pregnancy and breastfeeding are contraindications to refractive surgery in general, including PRK, whether participating in this study or not.
Show all 11Show fewer
- Residual, recurrent or active ocular diseases or corneal abnormalities in either eye such as iritis, uveitis, keratoconjunctivitis sicca, herpetic keratitis, vernal conjunctivitis, lagophthalmos, corneal scarring, anterior basement membrane disease, recurrent erosions, glaucoma, previous steroid responder, occludable chamber angles, visually significant cataracts
- Previous corneal or intraocular surgery in either eye for refractive or therapeutic purposes
- Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane®), amiodarone hydrochloride (Cordarone®) and/or sumatriptan (Imitrex®) (other medications in the same family as Imitrex will still be allowed)
- Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
- Individuals not legally competent to provide informed consent (e.g., incapacitated individuals, cognitively impaired) will not be enrolled. All subjects must provide consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Rose Sia contact
United States1 site, 1 recruiting
- Recruiting
Alexander T. Augusta Military Medical Center
Fort Belvoir, Virginia, 22060
Benjamin G Kuhar, OD, 571-231-1600, dha.belvoir.fbch.mbx.wresp-research@health.mil
Angelica Ochoa, 571-231-1670, dha.belvoirfbch.mbx.wresp-research@health.mil
About this study
Official title: Lacripep, a Novel Investigational Agent, for Corneal Wound Healing and Ocular Surface Homeostasis
The objective of this study is to evaluate the safety and effectiveness of Lacripep as a therapy for superficial corneal injury repair after Photorefractive keratectomy (PRK).
Read the detailed description
The purpose of this study is to assess the effect of an eyedrop medication, Lacripep, on wound healing in the cornea (the transparent tissue covering the front of the eye) such as seen after incidental or combat related trauma, or from eye surgeries like Photorefractive keratectomy (PRK). This study will help understand if Lacripep is an effective treatment in ocular surface healing and speeding visual recovery after injury.
Participants must be an active-duty service member or a dependent eligible for care at a military treatment facility.
- Conditions
- Corneal Epithelial Wound Healing
- Being tested
- 0.00025% Lacripep ophthalmic solution and Placebo
- Keywords
- Cornea, Wound healing, PRK, Lacritin, Lacripep
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.00025% Lacripep ophthalmic solution and PlaceboDrug
Participant will receive Lacripep in one eye and placebo in the other eye at the same time.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Participants will receive Lacripep in one eye and placebo in the other eye at the same time. Receives: Drug: 0.00025% Lacripep ophthalmic solution and Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Lacripep
To determine the efficacy of Lacripep for corneal wound healing, epithelial thickness will be be measured using optical coherence tomography (OCT). OCT is a non-invasive imaging technique that uses light waves to create detailed images of tissue structures.
Measured: Epithelial thickness assessment will be performed at 4 and 7 days postoperatively then at 1, 3 and 6 months postoperatively.
Secondary outcomes (1)
Lacripep safety
To determine the safety of Lacripep, the return of corrected distance visual acuity (CDVA) will be measured using high contrast visual acuity test. Return of CDVA will be defined as percentage of eyes with no more than 1 CDVA line lost from preoperative baseline.
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start23 May 2025
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (65)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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will: 1. Undergo photorefractive keratectomy (PRK), which is an eye surgery to improve vision. 2. Use two types of experimental eyedrops three times a day for three weeks. There will be separate containers of eyedrops for the right eye and the left eye. One eye will get the active eyedrop (Lacripep) and the other eye will get the placebo eyedrop (saline).
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- TearSolutions, Inc., Walter Reed National Military Medical Center
- Responsible party
- Sponsor
- Investigators
- Benjamin G Kuhar, OD, Principal investigator, Alexander T. Augusta Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854393
- Sponsor's protocol ID
- WRNMMC-2024-0470
- Other IDs
- HT94252411092
- Status last verified
- Sep 2026
- First submitted
- 18 Feb 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yulek F, Ozdek S, Gurelik G, Hasanreisoglu B. Effect of topical steroids on corneal epithelial healing after vitreoretinal surgery. Acta Ophthalmol Scand. 2006 Jun;84(3):319-22. doi: 10.1111/j.1600-0420.2005.00632.x.
PubMed 16704691Wong HL, Poon SHL, Bu Y, Lo ACY, Jhanji V, Chan YK, Shih KC. A Systematic Review on Cornea Epithelial-Stromal Homeostasis. Ophthalmic Res. 2021;64(2):178-191. doi: 10.1159/000509030. Epub 2020 May 29.
PubMed 32474566Wolsey D, Slade S, Wirostko BM, Brandano LA, Mann BK, Durrie DS, Thompson V. Novel Cross-Linked Ocular Bandage Gel Improves Reepithelialization After Photorefractive Keratectomy: A Randomized, Masked Prospective Study. J Ocul Pharmacol Ther. 2020 Oct;36(8):602-608. doi: 10.1089/jop.2019.0156. Epub 2020 Jul 17.
PubMed 32701012Wilson SE. Interleukin-1 and Transforming Growth Factor Beta: Commonly Opposing, but Sometimes Supporting, Master Regulators of the Corneal Wound Healing Response to Injury. Invest Ophthalmol Vis Sci. 2021 Apr 1;62(4):8. doi: 10.1167/iovs.62.4.8.
PubMed 33825855Wilson SE. Corneal wound healing. Exp Eye Res. 2020 Aug;197:108089. doi: 10.1016/j.exer.2020.108089. Epub 2020 Jun 15.
PubMed 32553485Weng TH, Chang YM, Lin FH, Weng ZX, Wang TW, Chen YH, Tai MC, Chen JT, Liang CM, Lin TY. Investigation of corneal epithelial thickness and irregularity by optical coherence tomography after transepithelial photorefractive keratectomy. Clin Exp Optom. 2024 Jan;107(1):23-31. doi: 10.1080/08164622.2023.2197107. Epub 2023 Apr 20.
PubMed 37078178Weichel ED, Colyer MH, Ludlow SE, Bower KS, Eiseman AS. Combat ocular trauma visual outcomes during operations iraqi and enduring freedom. Ophthalmology. 2008 Dec;115(12):2235-45. doi: 10.1016/j.ophtha.2008.08.033.
PubMed 19041478Wang W, Despanie J, Shi P, Edman-Woolcott MC, Lin YA, Cui H, Heur JM, Fini ME, Hamm-Alvarez SF, MacKay JA. Lacritin-mediated regeneration of the corneal epithelia by protein polymer nanoparticles. J Mater Chem B. 2014 Dec 14;2(46):8131-8141. doi: 10.1039/C4TB00979G.
PubMed 25530855Wang N, Zimmerman K, Raab RW, McKown RL, Hutnik CM, Talla V, Tyler MF 4th, Lee JK, Laurie GW. Lacritin rescues stressed epithelia via rapid forkhead box O3 (FOXO3)-associated autophagy that restores metabolism. J Biol Chem. 2013 Jun 21;288(25):18146-61. doi: 10.1074/jbc.M112.436584. Epub 2013 May 2.
PubMed 23640897Wang J, Wang N, Xie J, Walton SC, McKown RL, Raab RW, Ma P, Beck SL, Coffman GL, Hussaini IM, Laurie GW. Restricted epithelial proliferation by lacritin via PKCalpha-dependent NFAT and mTOR pathways. J Cell Biol. 2006 Aug 28;174(5):689-700. doi: 10.1083/jcb.200605140. Epub 2006 Aug 21.
PubMed 16923831Vlasov A, Sia RK, Ryan DS, Mines MJ, Stutzman RD, Rivers BA, Tseng SC, Bower KS. Sutureless cryopreserved amniotic membrane graft and wound healing after photorefractive keratectomy. J Cataract Refract Surg. 2016 Mar;42(3):435-43. doi: 10.1016/j.jcrs.2015.11.045.
PubMed 27063525Vlasov A, Ryan DS, Ludlow S, Coggin A, Weichel ED, Stutzman RD, Bower KS, Colyer MH. Corneal and Corneoscleral Injury in Combat Ocular Trauma from Operations Iraqi Freedom and Enduring Freedom. Mil Med. 2017 Mar;182(S1):114-119. doi: 10.7205/MILMED-D-16-00041.
PubMed 28291461Vijmasi T, Chen FY, Balasubbu S, Gallup M, McKown RL, Laurie GW, McNamara NA. Topical administration of lacritin is a novel therapy for aqueous-deficient dry eye disease. Invest Ophthalmol Vis Sci. 2014 Jul 17;55(8):5401-9. doi: 10.1167/iovs.14-13924.
PubMed 25034600Townley R. The state of refractive surgery in the U.S. Air Force. Presented at: Military Refractive Safety and Standards Symposium; January 7-10, 2019; San Diego, CA
Tomas-Juan J, Murueta-Goyena Larranaga A, Hanneken L. Corneal Regeneration After Photorefractive Keratectomy: A Review. J Optom. 2015 Jul-Sep;8(3):149-69. doi: 10.1016/j.optom.2014.09.001. Epub 2014 Oct 23.
PubMed 25444646
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lacripep, a Novel Investigational Agent, for Corneal Wound Healing and Ocular Surface Homeostasis
- ClinicalTrials.gov ID
- NCT06854393
- Acronym / sponsor ID
- WRNMMC-2024-0470
- Conditions
- Corneal Epithelial Wound Healing
- Keywords
- Cornea, Wound healing, PRK, Lacritin, Lacripep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- TearSolutions, Inc., Walter Reed National Military Medical Center
- Study start
- 23 May 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 3 Mar 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.
The objective of this study is to evaluate the safety and effectiveness of Lacripep as a therapy for superficial corneal injury repair after Photorefractive keratectomy (PRK).
Detailed description
The purpose of this study is to assess the effect of an eyedrop medication, Lacripep, on wound healing in the cornea (the transparent tissue covering the front of the eye) such as seen after incidental or combat related trauma, or from eye surgeries like Photorefractive keratectomy (PRK). This study will help understand if Lacripep is an effective treatment in ocular surface healing and speeding visual recovery after injury.
Participants must be an active-duty service member or a dependent eligible for care at a military treatment facility.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will: 1. Undergo photorefractive keratectomy (PRK), which is an eye surgery to improve vision. 2. Use two types of experimental eyedrops three times a day for three weeks. There will be separate containers of eyedrops for the right eye and the left eye. One eye will get the active eyedrop (Lacripep) and the other eye will get the placebo eyedrop (saline).
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: 0.00025% Lacripep ophthalmic solution and PlaceboParticipants will receive Lacripep in one eye and placebo in the other eye at the same time. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female, of any race, 21 years old and older
- Active-duty U.S. military service members or their dependents eligible for care at Alexander T. Augusta Military Medical Center for 6-month period postoperatively
- Desiring refractive correction of myopia up to -4.00 diopters (D) sphere with or without astigmatism 0 to -1.50 D and up to -4.00 D manifest spherical equivalent in both eyes
- Stable refraction for the past year as demonstrated by a change in manifest refractive spherical equivalent of ≤ 0.50 diopters (D) in both eyes
- CDVA of at least 20/20 in both eyes
Key exclusion criteria (11 listed)
- Calculated ablation depth of greater than 75 microns or other conditions in either eye which in the judgement of the investigators will require use of prophylactic MMC
- Signs of unstable or progressive myopia, keratoconus or keratoconus suspect in either eye
- Abnormal corneal topographic findings in either eye e.g., keratoconus, pellucid marginal degeneration
- Treatment targeted for monovision
- Signs and symptoms of dry eye based on: (a) Corneal fluorescein staining total score ≥4 in the National Eye Institute (NEI)/Industry Workshop scale in either eye, (b) Anethetized Schirmer test score ≤5 mm/5 minutes in either eye, (c) Symptom score ≤40 using the Symptom Assessment in Dry Eye (SANDE) questionnaire in either eye
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 |
|---|---|---|
| 0.00025% Lacripep ophthalmic solution and PlaceboParticipant will receive Lacripep in one eye and placebo in the other eye at the same time. | Drug | Treatment |
Primary outcome
Efficacy of Lacripep
Time frame: Epithelial thickness assessment will be performed at 4 and 7 days postoperatively then at 1, 3 and 6 months postoperatively.
To determine the efficacy of Lacripep for corneal wound healing, epithelial thickness will be be measured using optical coherence tomography (OCT). OCT is a non-invasive imaging technique that uses light waves to create detailed images of tissue structures.
1 secondary outcome
Lacripep safety
Time frame: From enrollment to the end of treatment at 6 months
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 3 Sep 2026.
- Background: PubMed 16704691Yulek F, Ozdek S, Gurelik G, Hasanreisoglu B. Effect of topical steroids on corneal epithelial healing after vitreoretinal surgery. Acta Ophthalmol Scand. 2006 Jun;84(3):319-22. doi: 10.1111/j.1600-0420.2005.00632.x.
- Background: PubMed 32474566Wong HL, Poon SHL, Bu Y, Lo ACY, Jhanji V, Chan YK, Shih KC. A Systematic Review on Cornea Epithelial-Stromal Homeostasis. Ophthalmic Res. 2021;64(2):178-191. doi: 10.1159/000509030. Epub 2020 May 29.
- Background: PubMed 32701012Wolsey D, Slade S, Wirostko BM, Brandano LA, Mann BK, Durrie DS, Thompson V. Novel Cross-Linked Ocular Bandage Gel Improves Reepithelialization After Photorefractive Keratectomy: A Randomized, Masked Prospective Study. J Ocul Pharmacol Ther. 2020 Oct;36(8):602-608. doi: 10.1089/jop.2019.0156. Epub 2020 Jul 17.
- Background: PubMed 33825855Wilson SE. Interleukin-1 and Transforming Growth Factor Beta: Commonly Opposing, but Sometimes Supporting, Master Regulators of the Corneal Wound Healing Response to Injury. Invest Ophthalmol Vis Sci. 2021 Apr 1;62(4):8. doi: 10.1167/iovs.62.4.8.
- Background: PubMed 32553485Wilson SE. Corneal wound healing. Exp Eye Res. 2020 Aug;197:108089. doi: 10.1016/j.exer.2020.108089. Epub 2020 Jun 15.
- Background: PubMed 37078178Weng TH, Chang YM, Lin FH, Weng ZX, Wang TW, Chen YH, Tai MC, Chen JT, Liang CM, Lin TY. Investigation of corneal epithelial thickness and irregularity by optical coherence tomography after transepithelial photorefractive keratectomy. Clin Exp Optom. 2024 Jan;107(1):23-31. doi: 10.1080/08164622.2023.2197107. Epub 2023 Apr 20.
- Background: PubMed 19041478Weichel ED, Colyer MH, Ludlow SE, Bower KS, Eiseman AS. Combat ocular trauma visual outcomes during operations iraqi and enduring freedom. Ophthalmology. 2008 Dec;115(12):2235-45. doi: 10.1016/j.ophtha.2008.08.033.
- Background: PubMed 25530855Wang W, Despanie J, Shi P, Edman-Woolcott MC, Lin YA, Cui H, Heur JM, Fini ME, Hamm-Alvarez SF, MacKay JA. Lacritin-mediated regeneration of the corneal epithelia by protein polymer nanoparticles. J Mater Chem B. 2014 Dec 14;2(46):8131-8141. doi: 10.1039/C4TB00979G.
- Background: PubMed 23640897Wang N, Zimmerman K, Raab RW, McKown RL, Hutnik CM, Talla V, Tyler MF 4th, Lee JK, Laurie GW. Lacritin rescues stressed epithelia via rapid forkhead box O3 (FOXO3)-associated autophagy that restores metabolism. J Biol Chem. 2013 Jun 21;288(25):18146-61. doi: 10.1074/jbc.M112.436584. Epub 2013 May 2.
- Background: PubMed 16923831Wang J, Wang N, Xie J, Walton SC, McKown RL, Raab RW, Ma P, Beck SL, Coffman GL, Hussaini IM, Laurie GW. Restricted epithelial proliferation by lacritin via PKCalpha-dependent NFAT and mTOR pathways. J Cell Biol. 2006 Aug 28;174(5):689-700. doi: 10.1083/jcb.200605140. Epub 2006 Aug 21.
- Background: PubMed 27063525Vlasov A, Sia RK, Ryan DS, Mines MJ, Stutzman RD, Rivers BA, Tseng SC, Bower KS. Sutureless cryopreserved amniotic membrane graft and wound healing after photorefractive keratectomy. J Cataract Refract Surg. 2016 Mar;42(3):435-43. doi: 10.1016/j.jcrs.2015.11.045.
- Background: PubMed 28291461Vlasov A, Ryan DS, Ludlow S, Coggin A, Weichel ED, Stutzman RD, Bower KS, Colyer MH. Corneal and Corneoscleral Injury in Combat Ocular Trauma from Operations Iraqi Freedom and Enduring Freedom. Mil Med. 2017 Mar;182(S1):114-119. doi: 10.7205/MILMED-D-16-00041.
- Individual participant dataSharing planned: No
Related trials for Corneal Epithelial Wound Healing
Not yet recruitingPhase 4
Efficacy of Topical Insuline in Corneal Epithelial Healing Post PRK
Corneal Epithelial Wound Healing
Not yet recruitingPhase 4
Evaluation of Dexpanthenol and Hyaluronic Acid Eye Drops on Corneal Epithelialization After Trans Epithelial PRK
Corneal Epithelial Wound Healing
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.
Rose Sia contact
Benjamin G Kuhar, OD principal investigator
Alexander T. Augusta Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Corneal Epithelial Wound Healing, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
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 7 inclusion and 11 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 3 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Benjamin G Kuhar, OD (571-231-1600, benjamin.g.kuhar.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Lacripep (time frame: Epithelial thickness assessment will be performed at 4 and 7 days postoperatively then at 1, 3 and 6 months postoperatively.). 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 NCT06854393, which also lists 65 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 3 Sep 2026.