Vernal KeratoconjunctivitisPhase 4NCT01211327
Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda
A Phase 4 study testing Cyclosporine A and Dexamethasone in people with Vernal Keratoconjunctivitis, run by University Hospital, Ghent at 1 site in Rwanda.
Trial summary
Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory disease of unknown cause. It is a fairly common disease in hot, dry environments, representing as much as 3% of severe ophthalmic diseases and up to 33% of all eye pathology seen among young patients in eye clinics in Central… Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Vernal Keratoconjunctivitis
- What is being tested?
- Cyclosporine A and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteRwanda
- Study dates
- Jul 2008to Nov 2008
- Phase
- Phase 4
- 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- at least 5 years of age
Who cannot join
- being pregnant
- suffering from any other infectious or inflammatory ocular pathology
- using topical/ systemic corticosteroids, antihistamines, non-steroidal anti-inflammatory drugs or immunosuppressives 2 weeks prior to the trial
- been treated with steroid injection 6 months prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Cyclosporine in the Treatment of Vernal Keratoconjunctivitis in a Rwandan Eye Clinic; a Prospective Randomized Double-masked Clinical Trial
Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory disease of unknown cause. It is a fairly common disease in hot, dry environments, representing as much as 3% of severe ophthalmic diseases and up to 33% of all eye pathology seen among young patients in eye clinics in Central Africa. Symptoms and signs can persist for years with an important visual morbidity and social impact. Corneal changes (e.g. corneal ulcers) can be sight threatening, occurring in up to 10% of VKC children. Topical steroid therapy remains the current standard treatment, but in developing countries its use often is chronic and not medically supervised, potentially leading to bacterial infections, steroid-induced glaucoma and cataract. Chromoglycate drops have less side effects but lack the power to control a flare-up. Topical cyclosporine has the potential to offer an efficient but safer alternative to steroid drops in the management of VKC in an African setting. Its safety and efficiency in the management of vernal keratoconjunctivitis have been described in several uncontrolled studies and double-blind, placebo-controlled trials, but those studies were relatively small and involved populations outside Africa with predominantly palpebral and mixed forms of VKC. Controversy still remains on the efficiency of cyclosporine in severe forms of allergic conjunctivitis like VKC. We therefore undertake a larger prospective randomized double-masked, standard treatment controlled clinical trial in Central Africa to compare the short-term efficiency of cyclosporine A (CsA) 2% eye drops, solved in olive oil vehicle, with that of steroid drops in predominantly limbal forms of VKC. During 4 weeks the participants will be randomised to either cyclosporine or dexamethasone as attack treatment for VKC. The 4 weeks thereafter all participants will receive chromoglycate drops as maintenance treatment. Additional objectives are to document any difference in rebound phenomenon while on chromoglycate during the maintenance phase between the 2 treatment groups and to evaluate safety and tolerance of the test medication.
- Conditions
- Vernal Keratoconjunctivitis
- Being tested
- Cyclosporine A, Dexamethasone
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ADrug
Cyclosporine 2% eye drops
DexamethasoneDrug
Dexamethasone 0,1% eye drops
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine A | Experimental | Cyclosporine A (CsA) 2% eye drops Receives: Drug: Cyclosporine A |
| Dexamethasone | Active comparator | Dexamethasone 0,1% eye drops Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in score for symptoms and clinical signs between treatment arms
Differences in scores for symptoms and clinical signs individually and as a composite score between the treatment arms.
Symptoms are itchiness, tearing, stinging, discharge and photophobia. Signs are subtarsal scarring, limbal cysts, pseudogerontoxon, pseudomembrane, corneal plaque, shield-ulcer, bulbar hyperaemia, limbal pigmentation, punctate keratitis, tarsal plate papillae, corneal astigmatism, limbal follicles, conjunctivalisation of the cornea and trantas dots.
Measured: After 4 weeks at the end of 4 weeks test medication
Secondary outcomes (2)
Speed of symptom/sign reduction
To document any difference between the 2 treatment groups in speed of symptom/sign reduction during the attack treatment and in rebound phenomenon while on chromoglycate during the maintenance phase
Measured: At 2 weeks while on test medication and at 8 weeks at the end of a chromoglycate maintenance phase
Safety and tolerance of the test medication
To evaluate safety and tolerance of the test medication.
Measured: At 2 weeks while on test medication and at 8 weeks at the end of a chromoglycate maintenance phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2010 (estimated)
- Study startJul 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vernal KeratoconjunctivitisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 366 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Funds for Research in Ophthalmology (FRO) of Belgium, Novartis
- Investigators
- Philippe Kesteleyn, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01211327
- Sponsor's protocol ID
- UZ Ghent 003
- Status last verified
- Sep 2010
- First submitted
- 28 Sep 2010
- Last updated
- 29 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Cyclosporine in the Treatment of Vernal Keratoconjunctivitis in a Rwandan Eye Clinic; a Prospective Randomized Double-masked Clinical Trial
- ClinicalTrials.gov ID
- NCT01211327
- Acronym / sponsor ID
- UZ Ghent 003
- Conditions
- Vernal Keratoconjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Funds for Research in Ophthalmology (FRO) of Belgium, Novartis
- Study start
- Jul 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 29 Sep 2010 (estimated)
- 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.
Vernal keratoconjunctivitis (VKC) is a bilateral, chronic, external ocular inflammatory disease of unknown cause. It is a fairly common disease in hot, dry environments, representing as much as 3% of severe ophthalmic diseases and up to 33% of all eye pathology seen among young patients in eye clinics in Central Africa. Symptoms and signs can persist for years with an important visual morbidity and social impact. Corneal changes (e.g. corneal ulcers) can be sight threatening, occurring in up to 10% of VKC children. Topical steroid therapy remains the current standard treatment, but in developing countries its use often is chronic and not medically supervised, potentially leading to bacterial infections, steroid-induced glaucoma and cataract. Chromoglycate drops have less side effects but lack the power to control a flare-up. Topical cyclosporine has the potential to offer an efficient but safer alternative to steroid drops in the management of VKC in an African setting. Its safety and efficiency in the management of vernal keratoconjunctivitis have been described in several uncontrolled studies and double-blind, placebo-controlled trials, but those studies were relatively small and involved populations outside Africa with predominantly palpebral and mixed forms of VKC. Controversy still remains on the efficiency of cyclosporine in severe forms of allergic conjunctivitis like VKC. We therefore undertake a larger prospective randomized double-masked, standard treatment controlled clinical trial in Central Africa to compare the short-term efficiency of cyclosporine A (CsA) 2% eye drops, solved in olive oil vehicle, with that of steroid drops in predominantly limbal forms of VKC. During 4 weeks the participants will be randomised to either cyclosporine or dexamethasone as attack treatment for VKC. The 4 weeks thereafter all participants will receive chromoglycate drops as maintenance treatment. Additional objectives are to document any difference in rebound phenomenon while on chromoglycate during the maintenance phase between the 2 treatment groups and to evaluate safety and tolerance of the test medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A | Experimental | Drug: Cyclosporine ACyclosporine A (CsA) 2% eye drops |
| Dexamethasone | Active comparator | Drug: DexamethasoneDexamethasone 0,1% eye drops |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- at least 5 years of age
Key exclusion criteria (4 listed)
- being pregnant
- suffering from any other infectious or inflammatory ocular pathology
- using topical/ systemic corticosteroids, antihistamines, non-steroidal anti-inflammatory drugs or immunosuppressives 2 weeks prior to the trial
- been treated with steroid injection 6 months prior to the study
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 |
|---|---|---|
| Cyclosporine ACyclosporine 2% eye drops | Drug | Cyclosporine A |
| DexamethasoneDexamethasone 0,1% eye drops | Drug | Dexamethasone |
Primary outcome
Difference in score for symptoms and clinical signs between treatment arms
Time frame: After 4 weeks at the end of 4 weeks test medication
Differences in scores for symptoms and clinical signs individually and as a composite score between the treatment arms. Symptoms are itchiness, tearing, stinging, discharge and photophobia. Signs are subtarsal scarring, limbal cysts, pseudogerontoxon, pseudomembrane, corneal plaque, shield-ulcer, bulbar hyperaemia, limbal pigmentation, punctate keratitis, tarsal plate papillae, corneal astigmatism, limbal follicles, conjunctivalisation of the cornea and trantas dots.
2 secondary outcomes
Speed of symptom/sign reduction
Time frame: At 2 weeks while on test medication and at 8 weeks at the end of a chromoglycate maintenance phase
Safety and tolerance of the test medication
Time frame: At 2 weeks while on test medication and at 8 weeks at the end of a chromoglycate maintenance phase
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 29 Sep 2010.
- Website University Hospital GhentLink provided by the sponsor.
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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.
Philippe Kesteleyn, MD, PhD principal investigator
University Hospital, Ghent
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 Cyclosporine A and Dexamethasone in people with Vernal Keratoconjunctivitis, run by University Hospital, Ghent at 1 site in Rwanda.
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: finished, as of the sponsor's last update on 29 Sep 2010. 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 Rwanda. 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?
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?
Difference in score for symptoms and clinical signs between treatment arms (time frame: After 4 weeks at the end of 4 weeks test medication). 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 29 Sep 2010.