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AzTrials

Vernal KeratoconjunctivitisPhase 3NCT00426023

Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis

A Phase 3 study testing Cyclosporine A 0,05% eye drop and ketotifen fumarate 0.025% eye drops in people with Vernal Keratoconjunctivitis, run by Campus Bio-Medico University at 3 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This interventional study aims to evaluate the efficacy of Cyclosporine eye drop treatment in preventing relapses of Vernal Keratoconjunctivitis (VKC) and in treating the acute phases of the disease. Read more about this study

Who is it for?
Ages 5 to 50 years
Conditions the study is for
Vernal Keratoconjunctivitis
What is being tested?
Cyclosporine A 0,05% eye drop and ketotifen fumarate 0.025% eye drops
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
3 sitesItaly
Study dates
Feb 2007to Oct 2008
Phase
Phase 3
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 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Patients affected by VKC will be enrolled by the three Centres involved in the project
  • Diagnosis of VKC will be performed on the basis of personal and family history of systemic allergic diseases, clinical examination (presence of conjunctival tarsal and/or limbal papillae) and presence of eosinophils in the conjunctival scraping

Who cannot join

  • Contact lens wearers
  • Patients affected by other ocular diseases
  • Patients subjected to ocular surgery in the preceding 6 months
  • Patients under eye drop or systemic treatments for other diseases, or
  • Patients enrolled in experimental trials in the preceding 6 months

Trial locations and contacts

3 sites in 1 country.

Italy3 sites

  • University of Genova

    Genova

  • University of Padua

    Padua

  • University of Rome Campus Bio-Medico

    Rome, Rome, 00155

Other trials in Italy

About this study

Official title: Multicenter, Randomised, Double Masked, Controlled Studies on the Efficacy of Cyclosporine Eye Drop Treatment in Preventing Vernal Keratoconjunctivitis (VKC) Relapses and in Treating the Acute Phase.

This interventional study aims to evaluate the efficacy of Cyclosporine eye drop treatment in preventing relapses of Vernal Keratoconjunctivitis (VKC) and in treating the acute phases of the disease.

Read the detailed description

Vernal keratoconjunctivitis (VKC) is a severe allergic disease, characterised by chronic ocular surface inflammation with seasonal relapses. Active phases of VKC require treatment with topical steroids to control inflammation and corneal damage that may lead to impairment of visual function and severe ocular discomfort. To date, safe and effective therapies in preventing relapses and controlling active phases of VKC are not available. Few controlled trials have used topical Cyclosporine A (CsA) for the treatment of VKC. The present multicenter, double-masked, randomised, controlled clinical trial will allow to obtain further data on the safety and efficacy of topical treatment with Cyclosporine in patients affected by VKC. Moreover, this study will evaluate the efficacy of topical CsA in both preventing the relapses of VKC and controlling the active phases of the disease. It is important to highlight that Cyclosporine eye drops are not currently commercially available in Italy and must be custom-made by specialized pharmacies. As VKC mostly affects young patients, it influences their daily life and their social interactions. Moreover, the severe signs and symptoms of the disease result in frequent ophthalmologic controls, influencing school activities of children and working days for their parents with a relevant economic cost for the National Health System.

Comparisons: Efficacy of Cyclosporine A 0.05% eye-drops in preventing VKC relapses compared to standard antiallergic (Ketotifen fumarate 0.025% eye-drops) treatment, and efficacy of Cyclosporine A 0.1% eye-drops in controlling acute phases compared to antiinflammatory (Desametasone 0.15% eye drops) treatments.

Being tested
Cyclosporine A 0,05% eye drop, ketotifen fumarate 0.025% eye drops
Keywords
Vernal keratoconjunctivitis, Cyclosporine, Children, Clinical trial
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 A 0,05% eye dropDrug

    Also called NOVA22007

    Cyclosporine A 0.05% eye drops will be administered 2 times daily for six months in the first year of the study and in the second year of the study in a cross-over manner(from March to September)

  • ketotifen fumarate 0.025% eye dropsDrug

    Also called Zaditen collirio monodose

    ketotifen fumarate 0.025% eye drops 2 times daily for 6 months in the first year of the study (from March to September) and 6 months in the same period in the second year of the study in cross over manner.

Study groups in NCT00426023
Study groupRoleWhat they receive
1Experimentalthis group of patients is treated with the experimental drug (Cyclosporine A 0,05% eye drops) 2 times daily
Receives: Drug: Cyclosporine A 0,05% eye drop
2Active comparatorNot described
Receives: Drug: ketotifen fumarate 0.025% eye drops

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the number of relapses of ocular inflammation per year between cyclosporine and ketotifen treated groups. Relapses are defined as at least 100% increase of the sum of hyperemia, itching, Trantas dots and corneal involvement

    Measured: 2 years

Secondary outcomes (2)

  1. Differences of specific symptoms and signs, of TSyS, TSS, Quick questionnaire subscales and biochemical and

    Measured: 2 years

  2. molecular parameters will be evaluated at baseline, after 1, 3 and 6 months of treatment and after 1 month of treatment discontinuation

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionOct 2008
  4. Study completionOct 2008

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00426023
Sponsor's protocol ID
eudract 2006-003689-32
Other IDs
FARM5YZTZW, ALMA1
Status last verified
Jan 2009
First submitted
23 Jan 2007
Last updated
28 Jan 2009
Results posted
No

Publications

  • Bonini S, Bonini S, Lambiase A, Marchi S, Pasqualetti P, Zuccaro O, Rama P, Magrini L, Juhas T, Bucci MG. Vernal keratoconjunctivitis revisited: a case series of 195 patients with long-term followup. Ophthalmology. 2000 Jun;107(6):1157-63. doi: 10.1016/s0161-6420(00)00092-0.

    PubMed 10857837

  • Bonini S, Lambiase A, Sgrulletta R, Bonini S. Allergic chronic inflammation of the ocular surface in vernal keratoconjunctivitis. Curr Opin Allergy Clin Immunol. 2003 Oct;3(5):381-7. doi: 10.1097/00130832-200310000-00011.

    PubMed 14501439

  • Bonini S, Barney NP, Schiavone M, Centofanti M, Berruto A, Bonini S, Allansmith MR. Effectiveness of nedocromil sodium 2% eyedrops on clinical symptoms and tear fluid cytology of patients with vernal conjunctivitis. Eye (Lond). 1992;6 ( Pt 6):648-52. doi: 10.1038/eye.1992.139.

    PubMed 1337745

  • Bonini S, Micera A, Iovieno A, Lambiase A, Bonini S. Expression of Toll-like receptors in healthy and allergic conjunctiva. Ophthalmology. 2005 Sep;112(9):1528; discussion 1548-9. doi: 10.1016/j.ophtha.2005.04.009.

    PubMed 16023216

  • Mendicute J, Aranzasti C, Eder F, Ostolaza JI, Salaberria M. Topical cyclosporin A 2% in the treatment of vernal keratoconjunctivitis. Eye (Lond). 1997;11 ( Pt 1):75-8. doi: 10.1038/eye.1997.14.

    PubMed 9246280

  • Secchi AG, Tognon MS, Leonardi A. Topical use of cyclosporine in the treatment of vernal keratoconjunctivitis. Am J Ophthalmol. 1990 Dec 15;110(6):641-5. doi: 10.1016/s0002-9394(14)77061-8.

    PubMed 2248328

  • Gupta V, Sahu PK. Topical cyclosporin A in the management of vernal keratoconjunctivitis. Eye (Lond). 2001 Feb;15(Pt 1):39-41. doi: 10.1038/eye.2001.10.

    PubMed 11318292

  • BenEzra D, Pe'er J, Brodsky M, Cohen E. Cyclosporine eyedrops for the treatment of severe vernal keratoconjunctivitis. Am J Ophthalmol. 1986 Mar 15;101(3):278-82. doi: 10.1016/0002-9394(86)90819-6.

    PubMed 3953723

  • Leonardi A. Vernal keratoconjunctivitis: pathogenesis and treatment. Prog Retin Eye Res. 2002 May;21(3):319-39. doi: 10.1016/s1350-9462(02)00006-x.

    PubMed 12052387

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cyclosporine A 0,05% eye drop and ketotifen fumarate 0.025% eye drops in people with Vernal Keratoconjunctivitis, run by Campus Bio-Medico University at 3 sites 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 2 inclusion and 5 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 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

To compare the number of relapses of ocular inflammation per year between cyclosporine and ketotifen treated groups. Relapses are defined as at least 100% increase of the sum of hyperemia, itching, Trantas dots and corneal involvement (time frame: 2 years). 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 NCT00426023, which also lists 9 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 28 Jan 2009.

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