Allergic ConjunctivitisPhase 2NCT00836485
Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
A Phase 2 study testing Ketotifen 4.0% Patch, Olopatadine 0.2% and Artificial tears in people with Allergic Conjunctivitis, run by Senju USA, Inc. at 1 site in United States.
Trial summary
This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Ketotifen 4.0% Patch, Olopatadine 0.2% and Artificial tears
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Mar 2009
- 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
- 18 years of age of either sex and any race
- positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months
- able and willing to avoid all disallowed medication for the washout period and during the study
Who cannot join
- active ocular infection or skin condition
- ocular surgery within the past 3 months
- pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Ketotifen 4.0% Patch, Placebo, Olopatadine 0.2%, Artificial tears
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketotifen 4.0% PatchDrug
This investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours.
PlaceboDrug
The control is a placebo patch that contains only the inactive ingredients of ketotifen.
Olopatadine 0.2%Drug
Also called Pataday(TM)
1 gtt/eye on two separate occasions
Artificial tearsDrug
1 gtt/eye on two separate occasions
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Ketotifen 4.0% Patch Receives: Drug: Ketotifen 4.0% Patch |
| 2 | Placebo comparator | Placebo Patch Receives: Drug: Placebo |
| 3 | Active comparator | Pataday(TM) Receives: Drug: Olopatadine 0.2% |
| 4 | Placebo comparator | Placebo eye drops Receives: Drug: Artificial tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular itching and bulbar conjunctival redness
Measured: Visit 3 and Visit 4
Secondary outcomes (2)
Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge
Measured: Visit 3 and Visit 4
Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms
Measured: Visit 3 and Visit 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senju USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, ORA, Inc.TBD TBD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836485
- Sponsor's protocol ID
- SNJ-ALK201/08-003-11
- Status last verified
- Aug 2023
- First submitted
- 2 Feb 2009
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT00836485
- Acronym / sponsor ID
- SNJ-ALK201/08-003-11
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Senju USA, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 4 Feb 2009 (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 is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ketotifen 4.0% PatchKetotifen 4.0% Patch |
| 2 | Placebo comparator | Drug: PlaceboPlacebo Patch |
| 3 | Active comparator | Drug: Olopatadine 0.2%Pataday(TM) |
| 4 | Placebo comparator | Drug: Artificial tearsPlacebo eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age of either sex and any race
- positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months
- able and willing to avoid all disallowed medication for the washout period and during the study
Key exclusion criteria (3 listed)
- active ocular infection or skin condition
- ocular surgery within the past 3 months
- pregnancy or nursing
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 4.0% PatchThis investigational drug is a transdermal patch indicated to treat allergic conjunctivitis. Application is intended for overnight wear between 8-10 hours. | Drug | 1 |
| PlaceboThe control is a placebo patch that contains only the inactive ingredients of ketotifen. | Drug | 2 |
| Olopatadine 0.2%Also: Pataday(TM)1 gtt/eye on two separate occasions | Drug | 3 |
| Artificial tears1 gtt/eye on two separate occasions | Drug | 4 |
Primary outcome
Ocular itching and bulbar conjunctival redness
Time frame: Visit 3 and Visit 4
2 secondary outcomes
Ocular: Ciliary, episcleral, and inferior palpebral conjunctival redness; chemosis; lid swelling; tearing; ocular mucous discharge
Time frame: Visit 3 and Visit 4
Nasal: Rhinorrhea; ear or palate pruritis; nasal pruritis; nasal congestion; and a composite score of all nasal symptoms
Time frame: Visit 3 and Visit 4
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 4 Aug 2023.
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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.
Gail Torkildsen, MD principal investigator
ORA, Inc.
TBD TBD principal investigator
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 Ketotifen 4.0% Patch, Olopatadine 0.2% and Artificial tears in people with Allergic Conjunctivitis, run by Senju USA, Inc. 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 3 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 4 Aug 2023. 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?
Ocular itching and bulbar conjunctival redness (time frame: Visit 3 and Visit 4). 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 4 Aug 2023.