Allergic ConjunctivitisPhase 2NCT01639846
Evaluation of the Onset and Duration of Action of RX-10045 in Allergic Conjunctivitis
A Phase 2 study testing RX-10045 in people with Allergic Conjunctivitis, run by C.T. Development America, Inc. at 1 site in United States.
Trial summary
To purpose of this study is to establish the efficacy and safety of RX-10045 ophthalmic solution in alleviating the signs and symptoms 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?
- RX-10045
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2012
- 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
- Subjects MUST:
- Have a positive history of ocular allergies
- Have a positive bilateral conjunctival allergen challenge (CAC) reaction
Who cannot join
- Subjects MUST NOT:
- Have known contraindications or sensitivities to study medication or its components
- Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
- Use a disallowed medication during the period indicated prior to the enrollment or during the study
- Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
Official title: A Single-Center, Double-Masked, Randomized, Vehicle Controlled Evaluation of the Onset and Duration of Action of RX-10045 Ophthalmic Solution, 0.09% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC) Model of Allergic Conjunctivitis
To purpose of this study is to establish the efficacy and safety of RX-10045 ophthalmic solution in alleviating the signs and symptoms of allergic conjunctivitis
Read the detailed description
Allergies are relatively common among the general population. Ocular signs and symptoms include itching, discomfort, redness, chemosis, tearing, and eyelid swelling. Allergic reactions can vary from a mild, self-limiting disease, to a debilitating condition that significantly impairs the quality of life of allergen-sensitive individuals.
Currently approved treatments for ocular allergy reduce the signs and symptoms of the early phase reaction; however, evidence suggests that many patients suffer from the persistent late phase reaction. Manifestations of the late phase reaction occur 6 to 24 hours after allergen exposure and are characterized by an influx of acute inflammatory cells into the conjunctivae. Administration of anti-inflammatory agents decreases allergy signs and symptoms in both the early and late phase reactions.
RX-10045 has been shown to be efficacious in multiple pre-clinical dry eye disease models and in a pre-clinical model of allergic conjunctivitis. The objective of this clinical study is to assess the safety and efficacy of RX-10045 ophthalmic solution for the treatment of the signs and symptoms of allergic conjunctivitis induced in the Conjunctival Allergen Challenge Model of allergic conjunctivitis at 15 minutes and 8 hours after medication instillation. It is anticipated that RX-10045 has therapeutic potential for the treatment of allergic conjunctivitis and an acceptable risk-benefit profile.
- Conditions
- Allergic Conjunctivitis
- Being tested
- RX-10045, Vehicle for RX-10045 arm
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RX-10045Drug
RX-10045 Ophthalmic Solution, 0.09% At Visits 3A and 4, a trained study technician will instill one drop of the assigned, masked study treatment, into each eye.
Vehicle for RX-10045 armDrug
Vehicle of RX-10045 Ophthalmic Solution At Visits 3A and 4, a trained study technician will instill one drop of the assigned, masked study treatment, into each eye.
| Study group | Role | What they receive |
|---|---|---|
| RX-10045 active arm | Experimental | RX-10045 Ophthalmic Solution, 0.09% Receives: Drug: RX-10045 |
| Vehicle for RX-10045 arm | Placebo comparator | Vehicle of RX-10045 Ophthalmic Solution Receives: Drug: Vehicle for RX-10045 arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular itching
Ocular itching at defined timepoints up to 2 weeks
Measured: Baseline to day 14
Conjunctival redness
Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks
Measured: Baseline to day 14
Secondary outcomes (4)
Ciliary and episcleral redness
Ciliary and episcleral redness evaluated by the investigator at defined timepoints up to 2 weeks
Measured: Baseline to day 14
Chemosis
Chemosis evaluated by the investigator at defined timepoints up to 2 weeks
Measured: Baseline to day 14
Eyelid swelling
Eyelid swelling evaluated by the subject at defined timepoints up to 2 weeks
Measured: Baseline to day 14
Tearing
Tearing evaluated by the subject at defined timepoints up to 2 weeks
Measured: Baseline to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2012
- Study completionAug 2012
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- C.T. Development America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639846
- Sponsor's protocol ID
- CTD1202
- Status last verified
- Feb 2013
- First submitted
- 11 Jul 2012
- Last updated
- 8 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Masked, Randomized, Vehicle Controlled Evaluation of the Onset and Duration of Action of RX-10045 Ophthalmic Solution, 0.09% Compared to Vehicle in the Conjunctival Allergen Challenge (CAC) Model of Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT01639846
- Acronym / sponsor ID
- CTD1202
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- C.T. Development America, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 13 Jul 2012 (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.
To purpose of this study is to establish the efficacy and safety of RX-10045 ophthalmic solution in alleviating the signs and symptoms of allergic conjunctivitis
Detailed description
Allergies are relatively common among the general population. Ocular signs and symptoms include itching, discomfort, redness, chemosis, tearing, and eyelid swelling. Allergic reactions can vary from a mild, self-limiting disease, to a debilitating condition that significantly impairs the quality of life of allergen-sensitive individuals.
Currently approved treatments for ocular allergy reduce the signs and symptoms of the early phase reaction; however, evidence suggests that many patients suffer from the persistent late phase reaction. Manifestations of the late phase reaction occur 6 to 24 hours after allergen exposure and are characterized by an influx of acute inflammatory cells into the conjunctivae. Administration of anti-inflammatory agents decreases allergy signs and symptoms in both the early and late phase reactions.
RX-10045 has been shown to be efficacious in multiple pre-clinical dry eye disease models and in a pre-clinical model of allergic conjunctivitis. The objective of this clinical study is to assess the safety and efficacy of RX-10045 ophthalmic solution for the treatment of the signs and symptoms of allergic conjunctivitis induced in the Conjunctival Allergen Challenge Model of allergic conjunctivitis at 15 minutes and 8 hours after medication instillation. It is anticipated that RX-10045 has therapeutic potential for the treatment of allergic conjunctivitis and an acceptable risk-benefit profile.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RX-10045 active arm | Experimental | Drug: RX-10045RX-10045 Ophthalmic Solution, 0.09% |
| Vehicle for RX-10045 arm | Placebo comparator | Drug: Vehicle for RX-10045 armVehicle of RX-10045 Ophthalmic Solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a positive history of ocular allergies
- Have a positive bilateral conjunctival allergen challenge (CAC) reaction
Key exclusion criteria (5 listed)
- Have known contraindications or sensitivities to study medication or its components
- Have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
- Use a disallowed medication during the period indicated prior to the enrollment or during the study
- Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
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 |
|---|---|---|
| RX-10045RX-10045 Ophthalmic Solution, 0.09% At Visits 3A and 4, a trained study technician will instill one drop of the assigned, masked study treatment, into each eye. | Drug | RX-10045 active arm |
| Vehicle for RX-10045 armVehicle of RX-10045 Ophthalmic Solution At Visits 3A and 4, a trained study technician will instill one drop of the assigned, masked study treatment, into each eye. | Drug | Vehicle for RX-10045 arm |
Primary outcome
Ocular itching
Time frame: Baseline to day 14
Ocular itching at defined timepoints up to 2 weeks
Conjunctival redness
Time frame: Baseline to day 14
Conjunctival redness evaluated by the investigator at defined timepoints up to 2 weeks
4 secondary outcomes
Ciliary and episcleral redness
Time frame: Baseline to day 14
Chemosis
Time frame: Baseline to day 14
Eyelid swelling
Time frame: Baseline to day 14
Tearing
Time frame: Baseline to day 14
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 8 Feb 2013.
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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
Andover Eye Associates
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 RX-10045 in people with Allergic Conjunctivitis, run by C.T. Development America, 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 5 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 8 Feb 2013. 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 (time frame: Baseline to day 14). The study lists 2 primary outcomes in all. 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 8 Feb 2013.