Moderate to Severe Dry Eye SyndromePhase 3NCT00814515
Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
A Phase 3 study testing NOVA22007 (Ciclosporin 0.1%) and NOVA22007 in people with Moderate to Severe Dry Eye Syndrome, run by Santen SAS at 1 site in France.
Trial summary
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to Severe Dry Eye Syndrome
- What is being tested?
- NOVA22007 (Ciclosporin 0.1%) and NOVA22007
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 482 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Sep 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females 18 years of age or greater.
- At baseline, moderate to severe dry eye condition persisting despite conventional management.
Who cannot join
- Presence or history of any systemic or ocular disorder or condition, including ocular surgery, trauma or disease that could possibly interfere with the interpretation of study results.
- Any relevant ocular anomaly interfering with the ocular surface, including post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history or concomitant corneal ulcer of infectious origin, etc.
- Any other ocular diseases requiring topical ocular treatment during the study period.
- Patient who has participated in a clinical trial with a new active substance during the past month before study entry.
- Participation in another clinical study at the same time as the present study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome
- Conditions
- Moderate to Severe Dry Eye Syndrome
- Being tested
- NOVA22007 (Ciclosporin 0.1%), NOVA22007
- Keywords
- Moderate, Severe, Dry, Eye, Ciclosporin, Cyclosporine
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVA22007 (Ciclosporin 0.1%)Drug
Ciclosporin 0.1% Ophthalmic Emulsions
NOVA22007Drug
Vehicle
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Ciclosporin 0.1% Receives: Drug: NOVA22007 (Ciclosporin 0.1%) |
| 2 | Placebo comparator | Vehicle Receives: Drug: NOVA22007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal fluorescein staining (on modified Oxford scale)
Measured: Approximately 26 weeks
Patient's global score of all symptoms of ocular discomfort unrelated to study medication instillation, using a visual analog scale (VAS) ranging from 0%-100%
Measured: Approximately 26 weeks
Secondary outcomes (1)
• Ocular Symptom Disease Index© (OSDI©) questionnaire • Percentage of complete responder to corneal fluorescein staining (on modified Oxford scale), i.e. with corneal staining score =0 • Patient's score of each symptom of ocular discomfort unrelated to
Measured: Approximately 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Moderate to Severe Dry Eye SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Santen SAS
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814515
- Sponsor's protocol ID
- NVG06C103
- Status last verified
- Jul 2010
- First submitted
- 24 Dec 2008
- Last updated
- 16 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion Versus Vehicle in Patients With Moderate to Severe Dry Eye Syndrome
- ClinicalTrials.gov ID
- NCT00814515
- Acronym / sponsor ID
- NVG06C103
- Conditions
- Moderate to Severe Dry Eye Syndrome
- Keywords
- Moderate, Severe, Dry, Eye, Ciclosporin, Cyclosporine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- Santen SASIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 25 Dec 2008 (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.
A Phase III, Multicenter, Randomized, Controlled, Double-Masked Trial of NOVA22007 (Ciclosporin 0.1%) Ophthalmic Cationic Emulsion versus Vehicle in Patients with Moderate to Severe Dry Eye Syndrome
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: NOVA22007 (Ciclosporin 0.1%)Ciclosporin 0.1% |
| 2 | Placebo comparator | Drug: NOVA22007Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males or females 18 years of age or greater.
- At baseline, moderate to severe dry eye condition persisting despite conventional management.
Key exclusion criteria (5 listed)
- Presence or history of any systemic or ocular disorder or condition, including ocular surgery, trauma or disease that could possibly interfere with the interpretation of study results.
- Any relevant ocular anomaly interfering with the ocular surface, including post radiation keratitis, Stevens-Johnson syndrome, corneal ulcer history or concomitant corneal ulcer of infectious origin, etc.
- Any other ocular diseases requiring topical ocular treatment during the study period.
- Patient who has participated in a clinical trial with a new active substance during the past month before study entry.
- Participation in another clinical study at the same time as the present 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 |
|---|---|---|
| NOVA22007 (Ciclosporin 0.1%)Ciclosporin 0.1% Ophthalmic Emulsions | Drug | 1 |
| NOVA22007Vehicle | Drug | 2 |
Primary outcome
Corneal fluorescein staining (on modified Oxford scale)
Time frame: Approximately 26 weeks
Patient's global score of all symptoms of ocular discomfort unrelated to study medication instillation, using a visual analog scale (VAS) ranging from 0%-100%
Time frame: Approximately 26 weeks
1 secondary outcome
• Ocular Symptom Disease Index© (OSDI©) questionnaire • Percentage of complete responder to corneal fluorescein staining (on modified Oxford scale), i.e. with corneal staining score =0 • Patient's score of each symptom of ocular discomfort unrelated to
Time frame: Approximately 26 weeks
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 16 Jul 2010.
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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?
A Phase 3 study testing NOVA22007 (Ciclosporin 0.1%) and NOVA22007 in people with Moderate to Severe Dry Eye Syndrome, 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 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 16 Jul 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 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 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?
Corneal fluorescein staining (on modified Oxford scale) (time frame: Approximately 26 weeks). 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?
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 16 Jul 2010.