Seasonal Allergic ConjunctivitisPhase 4NCT00133627
Ketotifen Ophthalmic Solution With Emedastine in Patients With Seasonal Allergic Conjunctivitis
A Phase 4 study testing Ketotifen in people with Seasonal Allergic Conjunctivitis, run by Novartis at 1 site in China.
Trial summary
Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released when an allergic reaction occurs. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Seasonal Allergic Conjunctivitis
- What is being tested?
- Ketotifen
- How many people
- 229 participants
- Where
- 1 siteChina
- Study dates
- Apr 2005to Oct 2005
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 3 years or older.
- History of seasonal allergic conjunctivitis
- Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline:
- at least intensity degree 2 for itching, and
- at least intensity degree 4 for composite score of itching and conjunctival hyperaemia
Who cannot join
- Other systemic/ophthalmic conditions
- Presence of any form of allergic conjunctivitis other than seasonal allergic conjunctivitis (e.g. perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, giant papillary conjunctivitis).
- Active bacterial or viral conjunctivitis or history of ocular herpes.
- Presence or history of severe dry eye.
- Previous treatments
- Any systemic or ocular corticosteroids within two (2) weeks prior to randomization.
Show all 9Show fewer
- Any systemic or ocular mast cell stabilizers within two (2) weeks prior to randomization.
- Any other ophthalmic medication within three (3) days prior to randomization.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop formulation of a well tried antihistamine called ketotifen. This study will compare the efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular treatment for seasonal allergic conjunctivitis in China.
- Conditions
- Seasonal Allergic Conjunctivitis
- Being tested
- Ketotifen
- Keywords
- Allergic, Conjunctivitis, Ketotifen, Histamine
- Medical subject headings
- Conjunctivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetotifenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startApr 2005
- Primary completionOct 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic ConjunctivitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
- Investigators
- Sun Xinghuai, Principal investigator, Hospital of Shanghai Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133627
- Sponsor's protocol ID
- CZAD511ACN01
- Status last verified
- Nov 2011
- First submitted
- 22 Aug 2005
- Last updated
- 17 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Comparison Ketotifen Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT00133627
- Acronym / sponsor ID
- CZAD511ACN01
- Conditions
- Seasonal Allergic Conjunctivitis
- Keywords
- Allergic, Conjunctivitis, Ketotifen, Histamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Alcon Research
- Study start
- Apr 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 23 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.
Medications available for the treatment of seasonal allergic conjunctivitis include antihistamines. These medicines block the release of histamine, a substance in the body that is released when an allergic reaction occurs. Novartis (NVS) has developed an eye drop formulation of a well tried antihistamine called ketotifen. This study will compare the efficacy and the tolerability of ketotifen eye drops with emedastine, which is a popular treatment for seasonal allergic conjunctivitis in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 3 years or older.
- History of seasonal allergic conjunctivitis
- Presence of bilateral ocular itching/conjunctival hyperaemia (redness) at baseline:
Key exclusion criteria (9 listed)
- Other systemic/ophthalmic conditions
- Presence of any form of allergic conjunctivitis other than seasonal allergic conjunctivitis (e.g. perennial allergic conjunctivitis, vernal keratoconjunctivitis, atopic keratoconjunctivitis, giant papillary conjunctivitis).
- Active bacterial or viral conjunctivitis or history of ocular herpes.
- Presence or history of severe dry eye.
- Previous treatments
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 |
|---|---|---|
| Ketotifen | Drug | – |
Primary outcome
Not reported in the source record.
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 17 Nov 2011.
Related trials for Seasonal Allergic Conjunctivitis
RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
Allergic Rhinoconjunctivitis
Active, not recruitingObservational study
Tyrosine Allergoid Paediatric and Adult Study
Allergic Rhinitis Due to Pollen, Allergic Conjunctivitis
RecruitingPhase 2
Evaluation of TL-925 for the Treatment of Seasonal Allergic Conjunctivitis
Allergic Conjunctivitis
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.
Sun Xinghuai principal investigator
Hospital of Shanghai Medical University
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 Ketotifen in people with Seasonal Allergic Conjunctivitis, run by Novartis at 1 site in China.
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 9 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 17 Nov 2011. 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 China. 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.
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 17 Nov 2011.