Conjunctivitis, VernalHOR-VKC-2020NCT05038241
HORMONES IN VERNAL KERATOCONJUNCTIVITIS
An observational study of Conjunctivitis, Vernal, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
VKC is more common in males and tends to resolve with pubertal development. Clinical observation was not followed by an investigation that clarified whether there is a correlation between the hormonal pattern and the evolution of the disease, in particular it is not defined whether there is a correlation between the… Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Conjunctivitis, Vernal
- How many people
- 88 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 31 Dec 2021
- Phase
- Observational
- 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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study involves the enrollment of 2 groups of subjects: pubertal patients with active VKC and pubertal / postpuberal patients who have suffered from VKC in the past years, but no longer in 2021. To all the subjects under examination, both males both females, a blood sample is performed for the determination of hormonal levels, an allergological / ophthalmological evaluation to determine the phase of activity of the VKC and an endocrinological evaluation to determine the degree of pubertal development.
Who may be able to join
- Diagnosis of VKC assessed by an allergologist or ophthalmologist over 10 years of age
Who cannot join
- Presence of pre-existing pathologies of the endocrine system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HORMONAL ROLE IN VERNAL KERATOCONJUNCTIVITIS
VKC is more common in males and tends to resolve with pubertal development. Clinical observation was not followed by an investigation that clarified whether there is a correlation between the hormonal pattern and the evolution of the disease, in particular it is not defined whether there is a correlation between the hormonal pattern and the resolution of the disease.
This study aims to evaluate the hormonal pattern in patients with VKC and, in particular, the possible role of these hormones in the resolution of this condition in puberty.
Read the detailed description
The study presents a retrospective and prospective transversal observational design, non-pharmacological, monocentric, non-profit.
It is based on the collection of clinical, laboratory and therapy data on databases of patients affected by Vernal keratoconjunctivitis.
Participation in the study will be proposed to parents of patients with VKC over 10 years of age at puberty (B2 according to Tanner for females and G2 according to Tanner for males), based on endocrinological evaluation. Patients, differentiated by gender, will be divided into two groups: patients with active VKC and patients with resolved VKC. Both study groups will be offered a blood sample to determine the serum levels of LH, FSH, estradiol, DHEAS, androstenedione, total testosterone, SHBG, DHT, 17OH-progesterone, TSH-R, albumin, ACTH and cortisol. In postpuberal females, the sample must be taken in the first 5 days of the menstrual cycle.
This study provides for the enrollment of patients diagnosed with VKC followed at the Allergy Outpatient Clinic of the UOSD Pediatrics High Intensity of Care - IRCCS Ca 'Granda Foundation Ospedale Maggiore Policlinico di Milano. The source documentation of the data will be the medical record and the reports of the examinations, provided for by the study, performed at the Institute. On the same day, a blood sample and a pubertal stage assessment will be performed. An allergy / ophthalmological examination for VKC will be carried out only if it had not been performed in the 12 months prior to the execution of the blood sample. There is no follow-up.
- Conditions
- Conjunctivitis, Vernal
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active VKC | All females and males of pubertal age with active VKC undergo a blood sample for the determination of serum hormone levels, an allergological evaluation and an endocrinological evaluation. All is done at the time of enrollment. | |
| Previous active VKC | All females and males of pubertal age who suffered of VKC undergo a blood sample for the determination of serum hormone levels, an allergological evaluation and an endocrinological evaluation. All is done at the time of enrollment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the difference in serum total testosterone levels between the population of subjects with active VKC and the population of subjects with resolved VKC.
A venous blood sample is taken from all enrolled subjects for the determination of plasma testosterone. This collection is made in the morning, between 8.30 and 9.30 am.
Measured: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma testosterone. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
Secondary outcomes (3)
To evaluate the difference in serum levels of the other hormones investigated between the population of subjects with active VKC and the population of subjects with resolved VKC.
A venous blood sample is taken from all enrolled subjects for the determination of hormones. This collection is made in the morning, between 8.30 and 9.30 am.
Measured: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
To assess the correlation between serum hormone levels and VKC activity.
A venous blood sample is taken from all enrolled subjects for the determination of plasma hormones. This collection is made in the morning, between 8.30 and 9.30 am. VKC activity is determined by an allergologic evaluation at the time of enrollment.
Measured: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
To evaluate the possible presence of a serum hormone marker that may be related to the resolution of ocular symptoms.
A venous blood sample is taken from all enrolled subjects for the determination of plasma hormones. This collection is made in the morning, between 8.30 and 9.30 am. VKC activity is determined by an allergologic evaluation at the time of enrollment.
Measured: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Apr 2021
- Primary completion31 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conjunctivitis, VernalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038241
- Sponsor's protocol ID
- 1965
- Acronym
- HOR-VKC-2020
- Status last verified
- Aug 2021
- First submitted
- 29 Aug 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HORMONAL ROLE IN VERNAL KERATOCONJUNCTIVITIS
- ClinicalTrials.gov ID
- NCT05038241
- Acronym / sponsor ID
- HOR-VKC-2020 / 1965
- Conditions
- Conjunctivitis, Vernal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Sep 2021 (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.
VKC is more common in males and tends to resolve with pubertal development. Clinical observation was not followed by an investigation that clarified whether there is a correlation between the hormonal pattern and the evolution of the disease, in particular it is not defined whether there is a correlation between the hormonal pattern and the resolution of the disease.
This study aims to evaluate the hormonal pattern in patients with VKC and, in particular, the possible role of these hormones in the resolution of this condition in puberty.
Detailed description
The study presents a retrospective and prospective transversal observational design, non-pharmacological, monocentric, non-profit.
It is based on the collection of clinical, laboratory and therapy data on databases of patients affected by Vernal keratoconjunctivitis.
Participation in the study will be proposed to parents of patients with VKC over 10 years of age at puberty (B2 according to Tanner for females and G2 according to Tanner for males), based on endocrinological evaluation. Patients, differentiated by gender, will be divided into two groups: patients with active VKC and patients with resolved VKC. Both study groups will be offered a blood sample to determine the serum levels of LH, FSH, estradiol, DHEAS, androstenedione, total testosterone, SHBG, DHT, 17OH-progesterone, TSH-R, albumin, ACTH and cortisol. In postpuberal females, the sample must be taken in the first 5 days of the menstrual cycle.
This study provides for the enrollment of patients diagnosed with VKC followed at the Allergy Outpatient Clinic of the UOSD Pediatrics High Intensity of Care - IRCCS Ca 'Granda Foundation Ospedale Maggiore Policlinico di Milano. The source documentation of the data will be the medical record and the reports of the examinations, provided for by the study, performed at the Institute. On the same day, a blood sample and a pubertal stage assessment will be performed. An allergy / ophthalmological examination for VKC will be carried out only if it had not been performed in the 12 months prior to the execution of the blood sample. There is no follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active VKC | – | –All females and males of pubertal age with active VKC undergo a blood sample for the determination of serum hormone levels, an allergological evaluation and an endocrinological evaluation. All is done at the time of enrollment. |
| Previous active VKC | – | –All females and males of pubertal age who suffered of VKC undergo a blood sample for the determination of serum hormone levels, an allergological evaluation and an endocrinological evaluation. All is done at the time of enrollment. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study involves the enrollment of 2 groups of subjects: pubertal patients with active VKC and pubertal / postpuberal patients who have suffered from VKC in the past years, but no longer in 2021. To all the subjects under examination, both males both females, a blood sample is performed for the determination of hormonal levels, an allergological / ophthalmological evaluation to determine the phase of activity of the VKC and an endocrinological evaluation to determine the degree of pubertal development.
Key inclusion criteria (1 listed)
- Diagnosis of VKC assessed by an allergologist or ophthalmologist over 10 years of age
Key exclusion criteria (1 listed)
- Presence of pre-existing pathologies of the endocrine system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess the difference in serum total testosterone levels between the population of subjects with active VKC and the population of subjects with resolved VKC.
Time frame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma testosterone. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
A venous blood sample is taken from all enrolled subjects for the determination of plasma testosterone. This collection is made in the morning, between 8.30 and 9.30 am.
3 secondary outcomes
To evaluate the difference in serum levels of the other hormones investigated between the population of subjects with active VKC and the population of subjects with resolved VKC.
Time frame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
To assess the correlation between serum hormone levels and VKC activity.
Time frame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
To evaluate the possible presence of a serum hormone marker that may be related to the resolution of ocular symptoms.
Time frame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for plasma hormones. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.
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 22 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conjunctivitis, Vernal, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
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 1 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 22 Apr 2022. 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 Italy. 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.
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?
To assess the difference in serum total testosterone levels between the population of subjects with active VKC and the population of subjects with resolved VKC. (time frame: All subjects enrolled between April 2021 and October 2021 undergo a venous blood sample for the determination of plasma testosterone. This withdrawal is made in the morning, between 8.30 and 9.30 am, in a single determination at the time of enrollment.). 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 22 Apr 2022; AzTrials last refreshed its copy on 29 Oct 2026.