Allergic ConjunctivitisPhase 4NCT01390961
Comparison of Tolerability Between Two Allergy Drops
A Phase 4 study testing alacaftadine and naphazoline HCl & pheniramine maleate in people with Allergic Conjunctivitis, run by Hom, Milton M., OD, FAAO at 1 site in United States.
Trial summary
Comfort is compared between two allergy drops Read more about this study
- Who is it for?
- Ages 18 months and olderHealthy volunteers can take part
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- alacaftadine and naphazoline HCl & pheniramine maleate
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2012
- 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 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Between the ages of 18 and over inclusive.
- Males or females
- Patient is in generally good \& stable overall health.
- Patient likely to comply with study guidelines \& study visits.
- Informed consent signed.
- History of allergic conjunctivitis
- Current symptoms of allergic conjunctivitis assessed by the investigator
Who cannot join
- Corneal refractive surgery or contact lens wear within 6 months of this study.
- Current use of Restasis
- Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- Pregnant or lactating women.
- Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
Trial locations and contacts
1 site in 1 country.
About this study
Comfort is compared between two allergy drops
- Conditions
- Allergic Conjunctivitis
- Being tested
- alacaftadine and naphazoline HCl & pheniramine maleate
- Keywords
- Allergic conjunctivitis
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alacaftadine and naphazoline HCl & pheniramine maleateDrug
Also called Lastacaft, Opcon A
once a day
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability
Tolerability measured by questionnaire Visual Analog scale 1 to 100
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionDec 2011 (estimated)
- Study completionJan 2012 (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
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390961
- Sponsor's protocol ID
- IIT-000256
- Status last verified
- Jul 2011
- First submitted
- 7 Jul 2011
- Last updated
- 11 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tolerability Between Two Allergy Drops
- ClinicalTrials.gov ID
- NCT01390961
- Acronym / sponsor ID
- IIT-000256
- Conditions
- Allergic Conjunctivitis
- Keywords
- Allergic conjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Allergan
- Study start
- Aug 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 11 Jul 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.
Comfort is compared between two allergy drops
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Between the ages of 18 and over inclusive.
- Males or females
- Patient is in generally good \& stable overall health.
- Patient likely to comply with study guidelines \& study visits.
- Informed consent signed.
Key exclusion criteria (5 listed)
- Corneal refractive surgery or contact lens wear within 6 months of this study.
- Current use of Restasis
- Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- Pregnant or lactating women.
- Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
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 |
|---|---|---|
| alacaftadine and naphazoline HCl & pheniramine maleateAlso: Lastacaft, Opcon Aonce a day | Drug | – |
Primary outcome
Tolerability
Time frame: 8 weeks
Tolerability measured by questionnaire Visual Analog scale 1 to 100
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2011.
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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 4 study testing alacaftadine and naphazoline HCl & pheniramine maleate in people with Allergic Conjunctivitis, run by Hom, Milton M., OD, FAAO 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 7 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: status not confirmed, as of the sponsor's last update on 11 Jul 2011. 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 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?
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?
Tolerability (time frame: 8 weeks). 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 11 Jul 2011; AzTrials last refreshed its copy on 30 Oct 2026.