Allergic ConjunctivitisPhase 2NCT00375596
A Study Of The Safety And Effectiveness Of A New Treatment For Allergic Conjunctivitis
A Phase 2 study testing Ketotifen/vasoconstrictor in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated.
Trial summary
This study will evaluate the safety and efficacy of a new allergy medication Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Ketotifen/vasoconstrictor
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Be at least 6 years of age, of any race, or either gender.
- Have a positive allergic history of ocular allergies and a positive skin test reaction to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months.
- Have a calculated best-corrected visual acuity of 0.6 logMar or better in each eye as measured using an ETDRS chart.
- Positive bilateral CAC reaction at Visit 1 \& 2.
Who cannot join
- Have any known contraindications, allergies, or sensitivities to the use of any of the study medications, or their components.
- Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
- Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the baseline slit-lamp exam of any visit
About this study
Official title: Study Withdrawn Prior to Determining Official Title
This study will evaluate the safety and efficacy of a new allergy medication
Read the detailed description
Study withdrawn prior to determining study details
- Conditions
- Allergic Conjunctivitis
- Being tested
- Ketotifen/vasoconstrictor
- 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/vasoconstrictorDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and efficacy of a new allergy medication
STUDY WITHDRAWN PRIOR TO OUTCOME DETERMINATION
Measured: 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
Why it stopped: Study withdrawn without starting or enrolling subjects due to a business decision to not proceed with the project.
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
- Intervention model
- Parallel groups
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375596
- Sponsor's protocol ID
- C-02-06-001
- Status last verified
- Feb 2015
- First submitted
- 12 Sep 2006
- Last updated
- 20 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Withdrawn Prior to Determining Official Title
- ClinicalTrials.gov ID
- NCT00375596
- Acronym / sponsor ID
- C-02-06-001
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study withdrawn without starting or enrolling subjects due to a business decision to not proceed with the project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- First posted
- 13 Sep 2006 (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 will evaluate the safety and efficacy of a new allergy medication
Detailed description
Study withdrawn prior to determining study details
Study design
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 6 years of age, of any race, or either gender.
- Have a positive allergic history of ocular allergies and a positive skin test reaction to cat hair/dander, ragweed, tree and/or grass pollen within the past 24 months.
- Have a calculated best-corrected visual acuity of 0.6 logMar or better in each eye as measured using an ETDRS chart.
- Positive bilateral CAC reaction at Visit 1 \& 2.
Key exclusion criteria (3 listed)
- Have any known contraindications, allergies, or sensitivities to the use of any of the study medications, or their components.
- Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
- Manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the baseline slit-lamp exam of any visit
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/vasoconstrictor | Drug | – |
Primary outcome
Safety and efficacy of a new allergy medication
Time frame: 0
STUDY WITHDRAWN PRIOR TO OUTCOME DETERMINATION
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketotifen/vasoconstrictor in people with Allergic Conjunctivitis, run by Bausch & Lomb Incorporated.
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 4 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: withdrawn, as of the sponsor's last update on 20 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety and efficacy of a new allergy medication (time frame: 0). 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 20 Feb 2015.