Corneal DiseasePhase 1NCT05700864
NGF Treatment for Patients With Neuropathic Corneal Pain
A Phase 1 study testing Cenegermin-Bkbj in people with Corneal Disease and Neuropathy, run by Tufts Medical Center at 1 site in United States.
Trial summary
This prospective, single center, interventional, open-label, single arm, non-randomized trial seeks to investigate the efficacy of Oxervate® (cenergermin 0.002% eye drops) on ameliorating the signs and symptoms of neuropathic corneal pain (NCP). The study aims to enroll 28 subjects with NCP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Disease, Neuropathy
- What is being tested?
- Cenegermin-Bkbj
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2022to 1 Dec 2023
- Phase
- Phase 1
- 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
- Male or female aged ≥ 18 years
- Symptoms of neuropathic corneal pain at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.
- Positive ICVM findings
- If female with childbearing potential, have a negative pregnancy test
- Best corrected distance visual acuity, using corrective lenses if necessary, in the study eye of at least +1.0 Log MAR (Snellen <20/200)
- Satisfying all Informed Consent requirements
- Ability and willingness to comply with study procedures
- Ability to speak and understand the English language sufficiently to understand the study, provide written consent, and allow completion of all study assessments
Who cannot join
- Evidence of any active ocular infection
- Evidence of any intraocular inflammation
- Evidence of any persistent epithelial defect/ulcer
- Evidence of any corneal scar/corneal edema
- Presence of any other ocular conditions that require topical medications
- History of severe systemic allergy or severe ocular allergy
Show all 15Show fewer
- Inability to suspend topical medications during the duration of the study
- Inability to suspend oral medications for NCP.
- No changes in VAS score after topical 0.5% proparacaine hydrochloride (Alcaine, Alcon, Fort Worth, TX)
- History of any ocular surgery within three months before study Visit 1(day 0)
- Ocular surgery expected during the 16 weeks of the trial
- Use of refractive/therapeutic contact lenses during the study period
- Female patients that are pregnant/have a positive pregnancy test result/are breast-feeding/intend to become pregnant during the study treatment period
- Drug addiction/alcohol abuse within the last year
- Participation in another clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Efficacy of Recombinant Human Nerve Growth Factor (rhNGF) Treatment in Patients With Neuropathic Corneal Pain (NCP)
This prospective, single center, interventional, open-label, single arm, non-randomized trial seeks to investigate the efficacy of Oxervate® (cenergermin 0.002% eye drops) on ameliorating the signs and symptoms of neuropathic corneal pain (NCP). The study aims to enroll 28 subjects with NCP. All patients will be evaluated for clinical symptoms and signs of NCP, corneal staining and nerve regeneration (by IVCM) at Baseline (Visit 2) through the end of study (16 weeks post treatment).
Read the detailed description
During the screening (Visit 1 / Day -8) all procedures for inclusion will be performed. From the day of screening the participants will stop any kind of further previous ocular treatment regime, except commercially available preservative free artificial tears provided by Sponsor for 7 days and 9 days as maximum (day -8 to day -1+2) until the baseline(Visit 2) . At the end of the washout period (day -8 to day -1+2), participants meeting the entry criteria for this study will be assigned to receive the Oxervate® at 4times/daily dosing in both eyes for 4 weeks.
At Week 1, participants will be queried for adverse events. If the participant reports side effects while on 4times/daily dosing, subjects will be instructed to begin a modified dosing regimen: 4 times daily for 3 days, then 1 day off dosing. At Week 4, participants will be evaluated for clinically significant changes. If resolution of NCP or improvement is observed, Oxervate® will be discontinued. If there is partial/no-improvement, participants will be instructed to begin an increased dosing regimen of 6times/daily. If at any point during the intervention period ocular pain/irritation is worsened for a prolonged period, Oxervate® intervention will be discontinued.
During the 8 weeks of intervention, only the administration of Oxervate® is allowed. Nevertheless, if strictly needed, the participant can take preservative free artificial tears (provided by Sponsor). The use (n° drops/day) of preservative free artificial tears will be clearly documented in a participant's diary and in the CRF.
- Conditions
- Corneal Disease, Neuropathy
- Being tested
- Cenegermin-Bkbj
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cenegermin-BkbjDrug
Also called OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution
Cenegermin-bkbj ophthalmic solution administered as one drop in both eyes every 3 hours 4 times daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Oxervate® (cenegermin) | Experimental | OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj Receives: Drug: Cenegermin-Bkbj |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by corneal nerve regeneration.
Quantifying total number of nerves of the corneal subbasal nerve plexus through in vivo confocal microscopy IVCM), summation of main trunk and branch nerves in one image reported as frame/nerve. Change from baseline in nerve quantity on IVCM at 16 weeks.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by changes in ocular inflammation on in vivo confocal microscopy
Change in dendritic cell density on in vivo confocal microscopy from baseline to 16 weeks. The total nerve density will be assessed as the total nerve length in micrometers per image frame area (0.16mm^2), from the three best representative images of each eye.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by changes in ocular redness using the McMonnies/Chapman-Davies (MC-D) grading scale.
Changes in grade of conjunctival hyperemia and bulbar conjunctival redness using the McMonnies/Chapman-Davies (MC-D) scale 0-1-2-3-4-5, 0 being absent conjunctival redness and 5 being severe conjunctival hyperemia
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Secondary outcomes (10)
Occurrence of treatment-related adverse events assessed by severity and temporal relationship of study treatment.
The severity of each adverse event observed will be evaluated as serious or not serious. Occurrence will be evaluated as expected or unexpected in relation to treatment. The relationship of the event to the study treatment will be assessed by the investigator as possibly, probably, or definitely related.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Tolerability of OXERVATE 0.002% on neuropathic corneal pain as assessed by the ocular surface disease index (OSDI) questionnaire, change from baseline ocular symptom score on OSDI
The ocular surface disease index (OSDI) questionnaire is a 12-item assessment of ocular symptoms and their impact on vision-related functioning. Each of the 12 items of the OSDI are graded on a scale of 0 to 4, where 0 indicates none of the time; 1 some of the time; 2 half of the time; 3, most of the time; and 4 all of the time. The total OSDI score is then calculated by the sum of scores for all questions answered, multiplied by 100. This integer is then divided by [total number of questions answered) x 4]. The highest possible score on OSDI questionnaire being 100, represents most severe symptoms, whereas lower OSDI score represent lower symptom severity.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Patient Reported outcome on quality of life dimensions of OXERVATE 0.002% on neuropathic corneal pain as assessed by Ocular Pain Assessment Survey (OPAS), change from baseline ocular pain score on OPAS
The Ocular Pain Assessment Survey (OPAS) is a 27-item quantitative questionnaire designed to provide an assessment of the symptoms and quality of life effect of ocular pain. Each of the 27 items is graded on a scale of 0-10, or a scale of 0% to 100%, where 0 indicates none and 10 or 100 indicate maximum. The OPAS questionnaire assess quality of life dimensions by addressing ocular pain intensity, interference with daily activities, aggravating factors and associated symptoms, as well as non-ocular pain. Higher scores indicate greater impact on quality of life, whereas lower scores indicate less interference on quality of life dimensions.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Changes in corneal nerve function as assessed by hyperosmolar eye-drop test, change from baseline pain score on the Visual Analog Scale (VAS) at 16 weeks.
Pain score on the Visual Analog Scale graded from 0 to 10, where 0 is no pain and 10 is the worst pain one can imagine before and after a topical drop of hyperosmolar solution is applied to both eyes.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Resolution of peripheral pain component as assessed by proparacaine eye-drop test, change from baseline pain score on the Visual Analog Scale (VAS) at 16 weeks.
Pain score on the Visual Analog Scale graded from 0 to 10, where 0 is no pain and 10 is the worst pain one can imagine before and after a topical anesthetic drop (proparacaine) is applied to both eyes. Peripheral pain will be assessed by percent decrease in pain VAS score after topical proparacaine eye drop. Partial (greater than or equal to 50% decrease in pain VAS) or total pain relief with anesthetic drop is indicative of peripheral pain and no response to topical proparacaine is indicative of centralized neuropathic pain. Changes in pain VAS score reported after proparacaine drop from baseline to 16 weeks will be assessed.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Efficacy of OXERVATE 0.002% at a reduced-dose regime (3 days on/1 day off) in patients reporting ocular side-effects/ocular pain assessed by changes in ocular inflammation on in vivo confocal microscopy.
Change in dendritic cell density on in vivo confocal microscopy from baseline to 4 weeks, and at 16 weeks.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Efficacy of OXERVATE 0.002% at an increased-dose regime (6times/daily) for 4 weeks assessed by changes in ocular inflammation on in vivo confocal microscopy.
Change in dendritic cell density on in vivo confocal microscopy from baseline and 4 weeks measure, at 8 and 16 weeks.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Changes in aqueous tear production as assessed by Schirmer's II test, change from baseline measurement at 16 weeks.
The Schirmer's test will be performed 5 minutes after a drop of topical anesthesia with 0.5% proparacaine (Alcon Inc., Ft Worth TX) is applied to the eye. The Schirmer test is performed by placing a narrow filter-paper strip (5 x 35 mm strip of Whatman #41 filter paper) in the inferior cul-de-sac. The resultant Schirmer strip value will be reported after 5 minutes. Aqueous tear production will be measured by the length in millimeters that the strip wets during 5 minutes. Values less than 10 mm / 5 minutes indicate tear production insufficiency. Values greater than 25 mm / 5 minutes indicate normal tear production as expected from a healthy eye.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Change in the stability of the tear film as assessed by Tear Film Break Up Time (TFBUT), change from baseline measurement at 16 weeks.
The standard Tear Break Up Time measurement will be performed by dropping a fluorescein drop to the inferior tarsal conjunctiva and waiting 30 seconds. After several blinks, the tear film will be examined using a broad beam of the slit lamp with a blue filter. The time lapse between the last blink and the appearance of the first randomly distributed dark discontinuity in the fluorescein stained tear film will be measured three times and the mean value of the measurements will be calculated. Break-up times less than 10 seconds are considered abnormal. A positive change from baseline (increase in amount of seconds it take tear film to break up / show discontinuity) indicates improvement.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Changes in ocular surface integrity as assessed by NEI corneal staining scale, changes in corneal fluorescein staining from baseline at 16 weeks.
Corneal fluorescein staining will be performed after 2 minutes of application of a fluorescein drop. The entire cornea will be then examined using slit-lamp evaluation with cobalt blue illumination. Staining will be graded using the NEI grading scheme, with a total range of 0-15. Each corneal quadrant (central, superior, temporal, nasal, and inferior) will be graded for severity of staining on a scale of 0-3, 0 being no staining, 1 being mild staining, 2 being moderate staining, and 3 being severe staining. The total of all 5 corneal quadrants will be added together to get the resultant score per eye out of 15. 15/15 represents the most severe staining, whereas 0/15 represents no staining and greater ocular surface integrity and homeostasis.
Measured: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start1 Nov 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: Funding of study was withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dompé Farmaceutici S.p.A
- Responsible party
- Sponsor
- Investigators
- Pedram Hamrah, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05700864
- Sponsor's protocol ID
- STUDY00002840
- Status last verified
- Jan 2023
- First submitted
- 6 Sep 2022
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Recombinant Human Nerve Growth Factor (rhNGF) Treatment in Patients With Neuropathic Corneal Pain (NCP)
- ClinicalTrials.gov ID
- NCT05700864
- Acronym / sponsor ID
- STUDY00002840
- Conditions
- Corneal Disease, Neuropathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding of study was withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Dompé Farmaceutici S.p.A
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 26 Jan 2023 (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.
This prospective, single center, interventional, open-label, single arm, non-randomized trial seeks to investigate the efficacy of Oxervate® (cenergermin 0.002% eye drops) on ameliorating the signs and symptoms of neuropathic corneal pain (NCP). The study aims to enroll 28 subjects with NCP. All patients will be evaluated for clinical symptoms and signs of NCP, corneal staining and nerve regeneration (by IVCM) at Baseline (Visit 2) through the end of study (16 weeks post treatment).
Detailed description
During the screening (Visit 1 / Day -8) all procedures for inclusion will be performed. From the day of screening the participants will stop any kind of further previous ocular treatment regime, except commercially available preservative free artificial tears provided by Sponsor for 7 days and 9 days as maximum (day -8 to day -1+2) until the baseline(Visit 2) . At the end of the washout period (day -8 to day -1+2), participants meeting the entry criteria for this study will be assigned to receive the Oxervate® at 4times/daily dosing in both eyes for 4 weeks.
At Week 1, participants will be queried for adverse events. If the participant reports side effects while on 4times/daily dosing, subjects will be instructed to begin a modified dosing regimen: 4 times daily for 3 days, then 1 day off dosing. At Week 4, participants will be evaluated for clinically significant changes. If resolution of NCP or improvement is observed, Oxervate® will be discontinued. If there is partial/no-improvement, participants will be instructed to begin an increased dosing regimen of 6times/daily. If at any point during the intervention period ocular pain/irritation is worsened for a prolonged period, Oxervate® intervention will be discontinued.
During the 8 weeks of intervention, only the administration of Oxervate® is allowed. Nevertheless, if strictly needed, the participant can take preservative free artificial tears (provided by Sponsor). The use (n° drops/day) of preservative free artificial tears will be clearly documented in a participant's diary and in the CRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxervate® (cenegermin) | Experimental | Drug: Cenegermin-BkbjOXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged ≥ 18 years
- Symptoms of neuropathic corneal pain at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.
- Positive ICVM findings
- If female with childbearing potential, have a negative pregnancy test
- Best corrected distance visual acuity, using corrective lenses if necessary, in the study eye of at least +1.0 Log MAR (Snellen <20/200)
Key exclusion criteria (15 listed)
- Evidence of any active ocular infection
- Evidence of any intraocular inflammation
- Evidence of any persistent epithelial defect/ulcer
- Evidence of any corneal scar/corneal edema
- Presence of any other ocular conditions that require topical medications
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 |
|---|---|---|
| Cenegermin-BkbjAlso: OXERVATE™ 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solutionCenegermin-bkbj ophthalmic solution administered as one drop in both eyes every 3 hours 4 times daily for 4 weeks | Drug | Oxervate® (cenegermin) |
Primary outcome
Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by corneal nerve regeneration.
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Quantifying total number of nerves of the corneal subbasal nerve plexus through in vivo confocal microscopy IVCM), summation of main trunk and branch nerves in one image reported as frame/nerve. Change from baseline in nerve quantity on IVCM at 16 weeks.
Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by changes in ocular inflammation on in vivo confocal microscopy
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Change in dendritic cell density on in vivo confocal microscopy from baseline to 16 weeks. The total nerve density will be assessed as the total nerve length in micrometers per image frame area (0.16mm^2), from the three best representative images of each eye.
Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by changes in ocular redness using the McMonnies/Chapman-Davies (MC-D) grading scale.
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Changes in grade of conjunctival hyperemia and bulbar conjunctival redness using the McMonnies/Chapman-Davies (MC-D) scale 0-1-2-3-4-5, 0 being absent conjunctival redness and 5 being severe conjunctival hyperemia
10 secondary outcomes
Occurrence of treatment-related adverse events assessed by severity and temporal relationship of study treatment.
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Tolerability of OXERVATE 0.002% on neuropathic corneal pain as assessed by the ocular surface disease index (OSDI) questionnaire, change from baseline ocular symptom score on OSDI
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Patient Reported outcome on quality of life dimensions of OXERVATE 0.002% on neuropathic corneal pain as assessed by Ocular Pain Assessment Survey (OPAS), change from baseline ocular pain score on OPAS
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Changes in corneal nerve function as assessed by hyperosmolar eye-drop test, change from baseline pain score on the Visual Analog Scale (VAS) at 16 weeks.
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Resolution of peripheral pain component as assessed by proparacaine eye-drop test, change from baseline pain score on the Visual Analog Scale (VAS) at 16 weeks.
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Efficacy of OXERVATE 0.002% at a reduced-dose regime (3 days on/1 day off) in patients reporting ocular side-effects/ocular pain assessed by changes in ocular inflammation on in vivo confocal microscopy.
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Efficacy of OXERVATE 0.002% at an increased-dose regime (6times/daily) for 4 weeks assessed by changes in ocular inflammation on in vivo confocal microscopy.
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Changes in aqueous tear production as assessed by Schirmer's II test, change from baseline measurement at 16 weeks.
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Change in the stability of the tear film as assessed by Tear Film Break Up Time (TFBUT), change from baseline measurement at 16 weeks.
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Changes in ocular surface integrity as assessed by NEI corneal staining scale, changes in corneal fluorescein staining from baseline at 16 weeks.
Time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- 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.
Pedram Hamrah, MD principal investigator
Tufts 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 1 study testing Cenegermin-Bkbj in people with Corneal Disease and Neuropathy, run by Tufts Medical Center 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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 26 Jan 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy of OXERVATE 0.002% 4 times/daily on neuropathic corneal pain as assessed by corneal nerve regeneration. (time frame: From Baseline Visit to End of Study Visit (16 weeks post treatment)). The study lists 3 primary outcomes in all. 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 26 Jan 2023.