Allergic ConjunctivitisPhase 2NCT01275105
A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)
A Phase 2 study testing Brimonidine Tartrate 0.01%, Brimonidine Tartrate 0.025% and Oxymetazoline HCl 0.025% in people with Allergic Conjunctivitis, run by Eye Therapies, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model. 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?
- Brimonidine Tartrate 0.01%, Brimonidine Tartrate 0.025% and Oxymetazoline HCl 0.025%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Mar 2011
- 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
- Be at least 18 years of age;
- If female, cannot be not pregnant or nursing
- Have a positive skin test reaction to cat hair, cat dander, grasses, ragweed, dog dander, cockroach, dust mite, and/or trees 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;
Who cannot join
- Have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
- Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety;
- Have a presence of active ocular infection;
- Use specified disallowed medications during the study or appropriate pre-study washout period;
- Have any significant illness;
- Have planned surgery (ocular or systemic) during the trial period or within 30 days after;
- Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;
- Be a female who is currently pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.
It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.
- Conditions
- Allergic Conjunctivitis
- Being tested
- Vehicle, Brimonidine Tartrate 0.01%, Brimonidine Tartrate 0.025%, Oxymetazoline HCl 0.025%
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VehicleDrug
one drop in each eye at designated visits
Brimonidine Tartrate 0.01%Drug
one drop in each eye at designated visits
Brimonidine Tartrate 0.025%Drug
one drop in each eye at designated visits
Oxymetazoline HCl 0.025%Drug
one drop in each eye at designated visits
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Other | Not described Receives: Drug: Vehicle |
| Brimonidine Tartrate 0.01% | Active comparator | Not described Receives: Drug: Brimonidine Tartrate 0.01% |
| Oxymetazoline HCl 0.025% | Active comparator | Not described Receives: Drug: Oxymetazoline HCl 0.025% |
| Brimonidine Tartrate 0.025% | Active comparator | Not described Receives: Drug: Brimonidine Tartrate 0.025% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conjunctival Redness
Measured: at specified timepoints for up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2011
- Study completionMar 2011
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eye Therapies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275105
- Sponsor's protocol ID
- 10-100-0008
- Status last verified
- Mar 2012
- First submitted
- 10 Jan 2011
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomized, Double-Masked, Placebo and Active Controlled, Dose-Ranging Evaluation of the Duration of Action of Brimonidine Tartrate Ophthalmic Solution in the Control of Ocular Redness Induced by Conjunctival Allergen Challenge (CAC)
- ClinicalTrials.gov ID
- NCT01275105
- Acronym / sponsor ID
- 10-100-0008
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Eye Therapies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- Jan 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 12 Jan 2011 (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 evaluate the safety, efficacy, and dose response of brimonidine tartrate ophthalmic solution as compared to placebo in the prevention of allergen-induced conjunctival redness using a conjunctival allergen challenge (CAC) model.
It is hypothesized that low-dose brimonidine tartrate ophthalmic solution will be more effective than vehicle in the prevention of conjunctival redness induced by conjunctival allergen challenge when instilled prior to the allergen challenge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Other | Drug: Vehicle |
| Brimonidine Tartrate 0.01% | Active comparator | Drug: Brimonidine Tartrate 0.01% |
| Oxymetazoline HCl 0.025% | Active comparator | Drug: Oxymetazoline HCl 0.025% |
| Brimonidine Tartrate 0.025% | Active comparator | Drug: Brimonidine Tartrate 0.025% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be at least 18 years of age;
- If female, cannot be not pregnant or nursing
- Have a positive skin test reaction to cat hair, cat dander, grasses, ragweed, dog dander, cockroach, dust mite, and/or trees 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;
Key exclusion criteria (8 listed)
- Have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
- Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety;
- Have a presence of active ocular infection;
- Use specified disallowed medications during the study or appropriate pre-study washout period;
- Have any significant illness;
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 |
|---|---|---|
| Vehicleone drop in each eye at designated visits | Drug | Vehicle |
| Brimonidine Tartrate 0.01%one drop in each eye at designated visits | Drug | Brimonidine Tartrate 0.01% |
| Brimonidine Tartrate 0.025%one drop in each eye at designated visits | Drug | Brimonidine Tartrate 0.025% |
| Oxymetazoline HCl 0.025%one drop in each eye at designated visits | Drug | Oxymetazoline HCl 0.025% |
Primary outcome
Conjunctival Redness
Time frame: at specified timepoints for up to 30 minutes
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 6 Mar 2012.
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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.
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 Brimonidine Tartrate 0.01%, Brimonidine Tartrate 0.025% and Oxymetazoline HCl 0.025% in people with Allergic Conjunctivitis, run by Eye Therapies, LLC 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 4 inclusion and 8 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 6 Mar 2012. 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. 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?
Conjunctival Redness (time frame: at specified timepoints for up to 30 minutes). 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 6 Mar 2012.