Conjunctivitis, VernalPhase 2/3NCT00328653
Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)
A Phase 2/3 study testing Cyclosporine NOVA22007 0.05% and Cyclosporine NOVA22007 0.1% in people with Conjunctivitis, Vernal, run by Santen SAS at 1 site in France.
Trial summary
The primary objective of this study is: To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Conjunctivitis, Vernal
- What is being tested?
- Cyclosporine NOVA22007 0.05% and Cyclosporine NOVA22007 0.1%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteFrance
- Study dates
- May 2006to 22 Feb 2007
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least the two following signs, in at least one eye* (the same eye should fulfill both criteria):
- Presence of giant papillae with a diameter ≥ 1 mm on the upper tarsal conjunctiva AND
- Superficial keratitis
- At least two of the following ocular symptoms with a score > 2 in at least one eye*: burning/stinging, tearing, itching, pain, sticky eyelids, foreign body sensation, mucus discharge, and photophobia.
- Hyperemia score equal to or greater than 2.
Who cannot join
- Concomitant corneal ulcer of infectious origin.
- Active ocular herpes
- Disease that could possibly interfere with the interpretation of the study results: active uveitis (defined by Tyndall score > 0), previous history of ocular hypertension or glaucoma, or condition incompatible with the frequent assessments needed by the study.
- Active herpes.
- History of malignancy or a recurrence in the last 5 years.
- Abnormality of nasolacrimal drainage apparatus.
Show all 11Show fewer
- Concomitant disease not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, trouble with thyroid secretions, etc.) or judged by the investigator to be incompatible with the study (e.g. current systemic infections), or condition incompatible with the frequent assessments needed by the study.
- Known hypersensitivity to one of the components of the investigational medicinal products (IMP) or test products.
- Severe systemic allergy requiring systemic treatment at study entry.
- Female of childbearing potential.
- History of drug or alcohol addiction (> 50g/day, 5 glasses alcohol/day).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II/III, Multicenter, Double-Masked, Randomized, Parallel Group, Dose Ranging, Controlled Trial of Efficacy and Tolerance of Nova22007 (Cyclosporine A [CSA] 0.05% & 0.1% Ophthalmic Cationic Emulsion) Versus Vehicle in Patients With VKC
The primary objective of this study is:
- To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period.
The secondary objectives of this study are:
- To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%;
- To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and
- To assess the decrease in frequency of concomitant artificial tears use.
- Conditions
- Conjunctivitis, Vernal
- Being tested
- Cyclosporine NOVA22007 0.05%, Cyclosporine NOVA22007 0.1%, Vehicle
- Keywords
- vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin
- Medical subject headings
- Conjunctivitis, Allergic, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine NOVA22007 0.05%Drug
Cyclosporine NOVA22007 0.1%Drug
VehicleDrug
| Study group | Role | What they receive |
|---|---|---|
| NOVA22007 0.05% | Experimental | four times daily Receives: Drug: Cyclosporine NOVA22007 0.05% |
| NOVA22007 0.1% | Experimental | four times daily Receives: Drug: Cyclosporine NOVA22007 0.1% |
| Vehicle | Sham comparator | administered four times daily Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Rating of Subjective Symptoms of VKC in Period I
The primary criteria of the trial was the overall rating of subjective symptoms in ocular symptoms of VKC as compared to Baseline and assessed at Week 4 (Month 1) based on a five-point scale based on BenEzra trial (BenEzra 1986):
- = Overall worsening of the subjective findings.
- = No change in the symptoms.
- = Slight improvement with the child still unable to participate in all normal daily activities.
- = Marked improvement despite temporary mild itching or mucus discharge.
- = Completely free of all symptoms.
Measured: Week 4
Overall Rating of Objective Symptoms of VKC in Period I
Overall rating of objective signs was to be assessed under the slit lamp by the Investigator and recorded on a five-point scale based on BenEzra trial (BenEzra 1986):
- Intense congestion of conjunctival vessels, perilimbal injection, or corneal involvement with the papillary proliferations more extensive or similar to the situation recorded before treatment in at least one of the eyes.
- The overall condition was assessed as better than before treatment in both eyes.
- Total re-epithelialisation of the cornea although slight conjunctival and perilimbal hyperaemia and papillary proliferations remains in both eyes.
- Only slight conjunctival hyperaemia without perilimbal injection or papillary proliferations in at least one eye
- Both eyes were quiet with no papillary proliferations or conjunctival or perilimbal injection.
Measured: Week 4
Secondary outcomes (2)
Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I
Measured: Up to Month1
Ocular Tolerance in Period I
Are the tested eye drops (other than concomitant tear substitute ) comfortable?
Measured: Up to Month1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startMay 2006
- Primary completion22 Feb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David BenEzra, Pf, Principal investigator, Haddassah University HospitalChristophe Baudouin, Pf., Study director, Hôpital des XV-XX 28 rue de Charenton 75012 Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328653
- Sponsor's protocol ID
- NOVATIVE - NVG05L101
- Status last verified
- Nov 2021
- First submitted
- 19 May 2006
- Last updated
- 14 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Leonardi A, Pisella PJ, Benitez-Del-Castillo JM, Amrane M, Ismail D, Doan S, Bremond-Gignac D. NOVATIVE: A Phase II/III, Multicenter, Double-masked, Randomized Study of Cyclosporine A 0.05% and 0.1% Ophthalmic Cationic Emulsion Versus Vehicle in Patients with Vernal Keratoconjunctivitis. Clin Ther. 2023 Dec;45(12):1284-1288. doi: 10.1016/j.clinthera.2023.09.022. Epub 2023 Oct 21.
PubMed 37872059
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III, Multicenter, Double-Masked, Randomized, Parallel Group, Dose Ranging, Controlled Trial of Efficacy and Tolerance of Nova22007 (Cyclosporine A [CSA] 0.05% & 0.1% Ophthalmic Cationic Emulsion) Versus Vehicle in Patients With VKC
- ClinicalTrials.gov ID
- NCT00328653
- Acronym / sponsor ID
- NOVATIVE - NVG05L101
- Conditions
- Conjunctivitis, Vernal
- Keywords
- vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Santen SASIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- 22 Feb 2007 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Posted 14 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is:
- To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period.
The secondary objectives of this study are:
- To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%;
- To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and
- To assess the decrease in frequency of concomitant artificial tears use.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NOVA22007 0.05% | Experimental | Drug: Cyclosporine NOVA22007 0.05%four times daily |
| NOVA22007 0.1% | Experimental | Drug: Cyclosporine NOVA22007 0.1%four times daily |
| Vehicle | Sham comparator | Drug: Vehicleadministered four times daily |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- At least the two following signs, in at least one eye* (the same eye should fulfill both criteria):
- At least two of the following ocular symptoms with a score > 2 in at least one eye*: burning/stinging, tearing, itching, pain, sticky eyelids, foreign body sensation, mucus discharge, and photophobia.
- Hyperemia score equal to or greater than 2.
Key exclusion criteria (11 listed)
- Concomitant corneal ulcer of infectious origin.
- Active ocular herpes
- Disease that could possibly interfere with the interpretation of the study results: active uveitis (defined by Tyndall score > 0), previous history of ocular hypertension or glaucoma, or condition incompatible with the frequent assessments needed by the study.
- Active herpes.
- History of malignancy or a recurrence in the last 5 years.
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 NOVA22007 0.05% | Drug | NOVA22007 0.05% |
| Cyclosporine NOVA22007 0.1% | Drug | NOVA22007 0.1% |
| Vehicle | Drug | Vehicle |
Primary outcome
Overall Rating of Subjective Symptoms of VKC in Period I
Time frame: Week 4
The primary criteria of the trial was the overall rating of subjective symptoms in ocular symptoms of VKC as compared to Baseline and assessed at Week 4 (Month 1) based on a five-point scale based on BenEzra trial (BenEzra 1986): 1. = Overall worsening of the subjective findings. 2. = No change in the symptoms. 3. = Slight improvement with the child still unable to participate in all normal daily activities. 4. = Marked improvement despite temporary mild itching or mucus discharge. 5. = Completely free of all symptoms.
Overall Rating of Objective Symptoms of VKC in Period I
Time frame: Week 4
Overall rating of objective signs was to be assessed under the slit lamp by the Investigator and recorded on a five-point scale based on BenEzra trial (BenEzra 1986): 1. Intense congestion of conjunctival vessels, perilimbal injection, or corneal involvement with the papillary proliferations more extensive or similar to the situation recorded before treatment in at least one of the eyes. 2. The overall condition was assessed as better than before treatment in both eyes. 3. Total re-epithelialisation of the cornea although slight conjunctival and perilimbal hyperaemia and papillary proliferations remains in both eyes. 4. Only slight conjunctival hyperaemia without perilimbal injection or papillary proliferations in at least one eye 5. Both eyes were quiet with no papillary proliferations or conjunctival or perilimbal injection.
2 secondary outcomes
Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I
Time frame: Up to Month1
Ocular Tolerance in Period I
Time frame: Up to Month1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37872059Leonardi A, Pisella PJ, Benitez-Del-Castillo JM, Amrane M, Ismail D, Doan S, Bremond-Gignac D. NOVATIVE: A Phase II/III, Multicenter, Double-masked, Randomized Study of Cyclosporine A 0.05% and 0.1% Ophthalmic Cationic Emulsion Versus Vehicle in Patients with Vernal Keratoconjunctivitis. Clin Ther. 2023 Dec;45(12):1284-1288. doi: 10.1016/j.clinthera.2023.09.022. Epub 2023 Oct 21.
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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.
David BenEzra, Pf principal investigator
Haddassah University Hospital
Christophe Baudouin, Pf. study director
Hôpital des XV-XX 28 rue de Charenton 75012 Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cyclosporine NOVA22007 0.05% and Cyclosporine NOVA22007 0.1% in people with Conjunctivitis, Vernal, run by Santen SAS at 1 site in France.
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 5 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: finished, as of the sponsor's last update on 14 Dec 2021. 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 France. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
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?
Yes. Results are posted in the registry (first posted 14 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Overall Rating of Subjective Symptoms of VKC in Period I (time frame: Week 4). The study lists 2 primary outcomes in all. 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 NCT00328653, which also lists 1 linked publication.
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 14 Dec 2021.