Allergic ConjunctivitisPhase 2NCT00443105
Topical Tacrolimus 0.03% Ointment for Intractable Allergic Conjunctivitis: An Open Label Pilot Study
A Phase 2 study testing Tacrolimus 0.03% ointment (Protopic) in people with Allergic Conjunctivitis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine the efficacy, tolerance and safety of tacrolimus 0.03% ointment in the treatment of intractable allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- Tacrolimus 0.03% ointment (Protopic)
- How many people
- Not given
- Where
- 1 siteIsrael
- 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 5 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Subjects included if they were > 5 years old and suffered from intractable allergic conjunctivitis
Who cannot join
- pregnancy or breastfeeding,history of herpetic eye disease,transplant patients concomitant administration of drugs inhibiting cytochrome CYP3A4, hypersensitivity to macrolides
Trial locations and contacts
1 site in 1 country.
Israel1 site
Assaf Harofeh Medical Center, Department of Ophthalmology
Tsrifin, 70300
About this study
The purpose of this study is to determine the efficacy, tolerance and safety of tacrolimus 0.03% ointment in the treatment of intractable allergic conjunctivitis.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Tacrolimus 0.03% ointment (Protopic)
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus 0.03% ointment (Protopic)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2007 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- David Zadok, MD, Principal investigator, Assaf Harofeh Medical Center, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443105
- Sponsor's protocol ID
- 20050321
- Status last verified
- Dec 2006
- First submitted
- 2 Mar 2007
- Last updated
- 5 Mar 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Tacrolimus 0.03% Ointment for Intractable Allergic Conjunctivitis: An Open Label Pilot Study
- ClinicalTrials.gov ID
- NCT00443105
- Acronym / sponsor ID
- 20050321
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- First posted
- 5 Mar 2007 (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.
The purpose of this study is to determine the efficacy, tolerance and safety of tacrolimus 0.03% ointment in the treatment of intractable allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects included if they were > 5 years old and suffered from intractable allergic conjunctivitis
Key exclusion criteria (1 listed)
- pregnancy or breastfeeding,history of herpetic eye disease,transplant patients concomitant administration of drugs inhibiting cytochrome CYP3A4, hypersensitivity to macrolides
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 |
|---|---|---|
| Tacrolimus 0.03% ointment (Protopic) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2007.
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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.
David Zadok, MD principal investigator
Assaf Harofeh Medical Center, Tel Aviv University
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 Tacrolimus 0.03% ointment (Protopic) in people with Allergic Conjunctivitis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Mar 2007. 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 Israel. 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 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?
Results are not available in the source record.
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 5 Mar 2007.