Conjunctivitis, AllergicPhase 4NCT00311844
A Study of the Effects of Desloratadine on Conjunctival Allergen Challenge-induced Ocular Signs and Symptoms (Study P04209)
A Phase 4 study testing desloratadine in people with Conjunctivitis, Allergic, run by Organon and Co.
Trial summary
This study was a double-blind, placebo-controlled, cross-over, single-center study of desloratadine 5 mg or placebo in subjects 18 years of age or older with a history of seasonal allergic rhinoconjunctivitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctivitis, Allergic
- What is being tested?
- desloratadine
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2005to 28 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate in the study and comply with the procedures, including adherence to dosing and visit schedules by signing informed consent
- 18 years of age or older, of either sex, and race, with normal health and asymptomatic
- At least a 2-year history (self-reported acceptable) of recurrent seasonal allergic conjunctivitis associated with seasonal allergic rhinitis
- Skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with the wheal diameter at least 7 mm larger than diluent control) at Screening, or within 12 months prior to the Screening Visit, to an appropriate seasonal allergen, including one or more of the following: Kentucky bluegrass (Poa pratensis)grass: meadow fescue, rye, Bermuda grass trees: oak, maple, birch cat hair or dander (Felis domesticus) ragweed
- Female subjects of childbearing potential must be using an acceptable method of birth control (ie, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized
- Female subjects of childbearing potential must have a negative urine pregnancy test at the Screening Visit
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- A calculated best-corrected visual acuity of 0.6 logMar or better in each eye as measured by an ETDRS chart
- Free of any clinically significant disease (other than SAR) that would interfere with study evaluations.
- Must agree to record symptom severity scores, medication times, concomitant medications, and adverse events accurately and consistently in a daily diary.
- At the Screening Visit, prior to the qualifying conjunctival allergen challenge, the subject must have an ocular symptom severity redness score of mild (<=1) prior to exposure to allergen. Following allergen challenge, the subject must achieve ocular itching and redness scores of at least moderate (>=2) in both eyes within 10 minutes of the last allergen challenge. For redness, the score must be >=2 in 2 of the 3 vessel beds. (details in section 8.2.6 and 8.3.2 of the protocol)
- At the confirmation visit, the subject must have ocular itching scores in both eyes of >=2 in 2 of the 3 timepoints (3, 5, and 7 minutes post-challenge). The subject must also have the following redness score bilaterally at 15 minutes post-challenge: >=2 in at least 2 vessel beds and >=6 composite oculare redness score
Who cannot join
- A female who is pregnant, intends to become pregnant during the study or is nursing
- Subject has not observed the designated washout periods for prohibited medication as per protocol Section 7.2. Antihistamines, inhaled nasal cromones, and inhaled nasal corticosteroids are prohibited for the months
- prior to Screening Visit
- Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease or other disease including those that would interfere with the absorption, distribution, metabolism, or excretion of the study drug, or with the subject's ability to complete diary cards
- Clinically significant deviation from normal in the physical and ocular exam, which may interfere with study evaluation or affect subject safety
- Participation in another clinical study
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- Use of any investigational product within 30 days of enrollment
- Subject is part of the study staff or family member of the staff directly involved with this study
- History of asthma being treated with inhaled or oral corticosteroids, beta-2-agonists, cromones, theophylline, or leukotriene inhibitors and cannot complete washout and study period without these medications
- A respiratory or ocular infection during the 4 weeks prior to pre-dose evaluations
- History of intranasal drug abuse
- Known potential for hypersensitivity, allergy or idiosyncratic reaction to study drug or excipients, or Claritin
- Upper respiratory tract or sinus infection that required antibiotics within 28 days of Screening, or had a viral upper respiratory infection within 7 days of Screening, or has persistent symptoms at Screening Visit
- Dependence on nasal, oral, or ocular decongestants, nasal topical antihistamines or nasal steroids
- Subjects on immunotherapy must remain on stable dose during the study. Subjects are not to have received desensitization treatment within 24 hours prior to a visit
- History of non-compliance with medication or treatment protocols
- History of difficulty swallowing pills or has known upper gastrointestinal narrowing or abnormal esophageal peristalsis
- Subject is a night-shift worker or does not have standard asleep at night/awake during the day cycle
- Unwilling to discontinue use of contact lenses during the course of the study
- Subject's ability to provide informed consent is compromised
About this study
Official title: A Double-blind, Placebo-controlled, Crossover, Single-center Study to Evaluate the Anti-allergic and Anti-inflammatory Effects of Multiple Doses of Desloratadine on Conjunctival Allergen Challenge-induced Ocular Signs and Symptoms
This study was a double-blind, placebo-controlled, cross-over, single-center study of desloratadine 5 mg or placebo in subjects 18 years of age or older with a history of seasonal allergic rhinoconjunctivitis. This study was performed to examine the effects of desloratadine compared with placebo, on the signs and symptoms of allergic conjunctivitis induced by direct conjunctival challenges with a previously identified sensitizing antigen, in the eyes of a subject known to be sensitive to the antigen.
- Conditions
- Conjunctivitis, Allergic
- Being tested
- desloratadine
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desloratadineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study start1 Mar 2005
- Primary completion28 May 2005
- Study completion28 May 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conjunctivitis, AllergicStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311844
- Sponsor's protocol ID
- P04209
- Status last verified
- Feb 2022
- First submitted
- 4 Apr 2006
- Last updated
- 15 Aug 2024
- Results posted
- No
Publications
Torkildsen GL, Gomes P, Welch D, Gopalan G, Srinivasan S. Evaluation of desloratadine on conjunctival allergen challenge-induced ocular symptoms. Clin Exp Allergy. 2009 Jul;39(7):1052-9. doi: 10.1111/j.1365-2222.2009.03224.x. Epub 2009 Mar 10.
PubMed 19302250
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Crossover, Single-center Study to Evaluate the Anti-allergic and Anti-inflammatory Effects of Multiple Doses of Desloratadine on Conjunctival Allergen Challenge-induced Ocular Signs and Symptoms
- ClinicalTrials.gov ID
- NCT00311844
- Acronym / sponsor ID
- P04209
- Conditions
- Conjunctivitis, Allergic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2005 (actual)
- Primary completion
- 28 May 2005 (actual)
- Study completion
- 28 May 2005 (actual)
- First posted
- 6 Apr 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 was a double-blind, placebo-controlled, cross-over, single-center study of desloratadine 5 mg or placebo in subjects 18 years of age or older with a history of seasonal allergic rhinoconjunctivitis. This study was performed to examine the effects of desloratadine compared with placebo, on the signs and symptoms of allergic conjunctivitis induced by direct conjunctival challenges with a previously identified sensitizing antigen, in the eyes of a subject known to be sensitive to the antigen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Willing to participate in the study and comply with the procedures, including adherence to dosing and visit schedules by signing informed consent
- 18 years of age or older, of either sex, and race, with normal health and asymptomatic
- At least a 2-year history (self-reported acceptable) of recurrent seasonal allergic conjunctivitis associated with seasonal allergic rhinitis
- Skin test positive (skin prick test with a wheal diameter at least 3 mm larger than the diluent control or intradermal testing with the wheal diameter at least 7 mm larger than diluent control) at Screening, or within 12 months prior to the Screening Visit, to an appropriate seasonal allergen, including one or more of the following: Kentucky bluegrass (Poa pratensis)grass: meadow fescue, rye, Bermuda grass trees: oak, maple, birch cat hair or dander (Felis domesticus) ragweed
- Female subjects of childbearing potential must be using an acceptable method of birth control (ie, hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized
Key exclusion criteria (20 listed)
- A female who is pregnant, intends to become pregnant during the study or is nursing
- Subject has not observed the designated washout periods for prohibited medication as per protocol Section 7.2. Antihistamines, inhaled nasal cromones, and inhaled nasal corticosteroids are prohibited for the months
- prior to Screening Visit
- Current evidence of clinically significant hematopoietic, cardiovascular, hepatic, immunologic, renal, neurologic, psychiatric, autoimmune disease or other disease including those that would interfere with the absorption, distribution, metabolism, or excretion of the study drug, or with the subject's ability to complete diary cards
- Clinically significant deviation from normal in the physical and ocular exam, which may interfere with study evaluation or affect subject safety
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 |
|---|---|---|
| desloratadine | 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 15 Aug 2024.
- Results publication: PubMed 19302250Torkildsen GL, Gomes P, Welch D, Gopalan G, Srinivasan S. Evaluation of desloratadine on conjunctival allergen challenge-induced ocular symptoms. Clin Exp Allergy. 2009 Jul;39(7):1052-9. doi: 10.1111/j.1365-2222.2009.03224.x. Epub 2009 Mar 10.
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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 4 study testing desloratadine in people with Conjunctivitis, Allergic, run by Organon and Co.
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 11 inclusion and 20 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 15 Aug 2024. 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 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?
On the ClinicalTrials.gov record for NCT00311844, which also lists 1 linked publication.
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 15 Aug 2024.