Allergic ConjunctivitisPhase 4(OAT-PIT)NCT01808768
Ocular Allergy Treatment Practical Impact Trial
A Phase 4 study testing Alcaftadine in people with Allergic Conjunctivitis and Rhinoconjunctivitis, run by Starx Research Center, LLC at 2 sites in United States.
Trial summary
To study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Conjunctivitis, Rhinoconjunctivitis
- What is being tested?
- Alcaftadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to Nov 2013
- 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
- patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens
- Total Ocular Symptom Score (TOSS) on the day of enrollment of 4 or more.
- have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment.
- Are willing/able to follow instructions from the study investigator and his/her study staff.
- Have signed infromed consent approved by Institutional Review Board or Independent Ethics Committee.
- -
Who cannot join
- Active ocular infection;
- History of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
- Ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study.
- History of unstable, or uncontrolled disease of any nature.
- Pregnancy or lactation;
- Have a known hypersensitivity tp LASTACAFT™ (alcaftadine) -
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
STARx Research Center
Edison, New Jersey, 08820
Erika Julca, lpn,crc, 732-906-1747, ejulca1@gmail.com
June Pepe, lpn, ccrc, 973-912-9817, pepejune@gmail.com
- Recruiting
STARx
Springfield, New Jersey, 07081
Leonard Bielory, MD, 973-912-9817, DrLBielory@gmail.com
Leonard Bielory, MD
About this study
Official title: To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)
To study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.
Read the detailed description
To assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(Lastacaft™)
- Conditions
- Allergic Conjunctivitis, Rhinoconjunctivitis
- Being tested
- Alcaftadine
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcaftadineDrug
Also called Lastacaft
Alcaftadine 0.25% one dorp each eye daily for 1-2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alcaftadine | Experimental | subject on any ocular allergy ophthalmic treatment or no treatment will be started on Alcaftadine 0.25%(study drug)- 1 drop each eye daily for 1-2 weeks Receives: Drug: Alcaftadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life- Eye Allergy Patient Impact Questionnaire
Measured: 4 months
Secondary outcomes (1)
Ocular Surface Disease Index Pollen Count correlation of symptoms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013 (estimated)
- Study completionNov 2013 (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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Starx Research Center, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jayesh G. Kanuga, M.D., Starx Research Center, LLC
- Investigators
- Jayesh Kanuga, MD, Principal investigator, Starx Research Center, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01808768
- Sponsor's protocol ID
- ID IIT- 000373
- Acronym
- (OAT-PIT)
- Status last verified
- Mar 2013
- First submitted
- 6 Mar 2013
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Impact of Ocular Allergy Treatment on Patients Using an Opthalmic Agent (or no Treatment) Versus Alcaftadine(Lastacaft™)
- ClinicalTrials.gov ID
- NCT01808768
- Acronym / sponsor ID
- (OAT-PIT) / ID IIT- 000373
- Conditions
- Allergic Conjunctivitis, Rhinoconjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Starx Research Center, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Nov 2013 (estimated)
- First posted
- 11 Mar 2013 (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 study the impact of alcaftadine in patients treated with other opthalmic ocular agents (or specific topical opthalmic treatment) in an allergy subspecialist outpatient setting.
Detailed description
To assess the impact of ocular allergy treatment on patients using an ophthalmic agent (or no treatment) versus alcaftadine(Lastacaft™)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alcaftadine | Experimental | Drug: Alcaftadinesubject on any ocular allergy ophthalmic treatment or no treatment will be started on Alcaftadine 0.25%(study drug)- 1 drop each eye daily for 1-2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients age 18 and older with a history of seasonal or perennial forms of allergic conjunctivitis and skin test positive reactivity to seasonal aeroallergens
- Total Ocular Symptom Score (TOSS) on the day of enrollment of 4 or more.
- have allergic ocular symptoms for the past week for which they are either treating with ophthalmic agents or have had no treatment.
- Are willing/able to follow instructions from the study investigator and his/her study staff.
- Have signed infromed consent approved by Institutional Review Board or Independent Ethics Committee.
Key exclusion criteria (6 listed)
- Active ocular infection;
- History of retinal detachment, diabetic neuropathy, or any progressive retinal disease;
- Ocular surgical intervention within three (3) months prior to visit 1 or scheduled during the study.
- History of unstable, or uncontrolled disease of any nature.
- Pregnancy or lactation;
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 |
|---|---|---|
| AlcaftadineAlso: LastacaftAlcaftadine 0.25% one dorp each eye daily for 1-2 weeks. | Drug | Alcaftadine |
Primary outcome
Quality of Life- Eye Allergy Patient Impact Questionnaire
Time frame: 4 months
1 secondary outcome
Ocular Surface Disease Index Pollen Count correlation of symptoms
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 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.
Jayesh Kanuga, MD principal investigator
Starx Research Center, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alcaftadine in people with Allergic Conjunctivitis and Rhinoconjunctivitis, run by Starx Research Center, LLC at 2 sites 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 6 inclusion and 6 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 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayesh Kanuga, MD (732-906-1747, jkanuga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life- Eye Allergy Patient Impact Questionnaire (time frame: 4 months). 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 30 May 2013.