Keratoconjunctivitis SiccaPhase 2NCT00128245
Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
A Phase 2 study testing Pimecrolimus in people with Keratoconjunctivitis Sicca, run by Novartis at 1 site in United States.
Trial summary
This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconjunctivitis Sicca
- What is being tested?
- Pimecrolimus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 2006
- Phase
- Phase 2
- 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
- History of artificial tear use
- Moderate to severe signs of dry eye
- Moderate to severe ocular discomfort
Who cannot join
- Patients with uncontrolled systemic or ocular diseases.
- Have any history of refractive surgery
- Use any topical ocular medications other than those dispensed for the study, during the study
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 24-week Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Evaluation of the Safety and Efficacy of 0.3% and 1% Pimecrolimus Ophthalmic Suspensions Used Twice Daily in Patients With Moderate to Severe Keratoconjunctivitis Sicca
This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.
- Conditions
- Keratoconjunctivitis Sicca
- Being tested
- Pimecrolimus, Vehicle
- Keywords
- KCS, dry eye, pimecrolimus, Keratoconjunctivitis sicca (dry eye syndrome)
- Medical subject headings
- Keratoconjunctivitis Sicca, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimecrolimusDrug
Also called ASM981
VehicleDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Pimecrolimus 0.3% | Experimental | ASM981 0.3% Receives: Drug: Pimecrolimus |
| Pimecrolimus 1% | Experimental | ASM981 1% Receives: Drug: Pimecrolimus |
| Vehicle with carbopol | Placebo comparator | Not described Receives: Drug: Vehicle |
| Vehicle without carbopol | Placebo comparator | Not described Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom
change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
Secondary outcomes (2)
24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
Global assessment of efficacy and tolerability
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconjunctivitis SiccaStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 440 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Foulks, Dr., Principal investigator, University of Louisville, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128245
- Sponsor's protocol ID
- CASM981E2205
- Status last verified
- Jan 2014
- First submitted
- 5 Aug 2005
- Last updated
- 27 May 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24-week Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Evaluation of the Safety and Efficacy of 0.3% and 1% Pimecrolimus Ophthalmic Suspensions Used Twice Daily in Patients With Moderate to Severe Keratoconjunctivitis Sicca
- ClinicalTrials.gov ID
- NCT00128245
- Acronym / sponsor ID
- CASM981E2205
- Conditions
- Keratoconjunctivitis Sicca
- Keywords
- KCS, dry eye, pimecrolimus, Keratoconjunctivitis sicca (dry eye syndrome)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 440 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Aug 2005 (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.
This study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pimecrolimus 0.3% | Experimental | Drug: PimecrolimusASM981 0.3% |
| Pimecrolimus 1% | Experimental | Drug: PimecrolimusASM981 1% |
| Vehicle with carbopol | Placebo comparator | Drug: Vehicle |
| Vehicle without carbopol | Placebo comparator | Drug: Vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of artificial tear use
- Moderate to severe signs of dry eye
- Moderate to severe ocular discomfort
Key exclusion criteria (4 listed)
- Patients with uncontrolled systemic or ocular diseases.
- Have any history of refractive surgery
- Use any topical ocular medications other than those dispensed for the study, during the study
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| PimecrolimusAlso: ASM981 | Drug | Pimecrolimus 0.3%, Pimecrolimus 1% |
| VehiclePlacebo | Drug | Vehicle with carbopol, Vehicle without carbopol |
Primary outcome
12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom
change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
2 secondary outcomes
24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
Global assessment of efficacy and tolerability
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 27 May 2020.
- Novartis patient recruitment websiteLink 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.
Gary Foulks, Dr. principal investigator
University of Louisville, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pimecrolimus in people with Keratoconjunctivitis Sicca, run by Novartis at 1 site in United States.
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 3 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 27 May 2020. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom. 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 27 May 2020.