Allergic ConjunctivitisPhase 3NCT00889330
Safety and Efficacy Study of a Eye Drop for Eye Allergy
A Phase 3 study testing alcaftadine in people with Allergic Conjunctivitis, run by Vistakon Pharmaceuticals at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Allergic Conjunctivitis
- What is being tested?
- alcaftadine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2009to May 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At least 10 years of age
- positive history of ocular allergies
- positive skin test reaction to allergens.
Who cannot join
- known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components
- ocular surgical intervention within three (3) months prior to visit 1 or during the study
- known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma
- any other significant illness
Trial locations and contacts
2 sites in 1 country.
About this study
The purpose of this study is to evaluate the efficacy and safety of an anti-allergy eyedrop.
- Conditions
- Allergic Conjunctivitis
- Being tested
- alcaftadine, Placebo
- 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
0.25% Ophthalmic Solution, one drop in each eye at each of two visits.
PlaceboDrug
Vehicle without active, one drop in each eye at each of two visits.
| Study group | Role | What they receive |
|---|---|---|
| alcaftadine ophthalmic solution | Experimental | active treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). Receives: Drug: alcaftadine |
| inactive ophthalmic solution vehicle | Placebo comparator | Placebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.
A 0 to 4 scale used, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation.
Measured: Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation
A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Measured: Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"
Measured: Visit 4 (Day 14) up to 7 minutes following Allergen Challenge
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation
A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Measured: Visit 4 (Day 14) At 20 minutes following Allergen Challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vistakon Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00889330
- Sponsor's protocol ID
- 09-003-05
- Status last verified
- Feb 2015
- First submitted
- 24 Apr 2009
- Last updated
- 6 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Torkildsen G, Shedden A. The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis. Curr Med Res Opin. 2011 Mar;27(3):623-31. doi: 10.1185/03007995.2010.548797. Epub 2011 Jan 21.
PubMed 21250860
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of a Eye Drop for Eye Allergy
- ClinicalTrials.gov ID
- NCT00889330
- Acronym / sponsor ID
- 09-003-05
- Conditions
- Allergic Conjunctivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vistakon PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- May 2009 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Posted 8 Dec 2011
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 efficacy and safety of an anti-allergy eyedrop.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alcaftadine ophthalmic solution | Experimental | Drug: alcaftadineactive treatment: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). |
| inactive ophthalmic solution vehicle | Placebo comparator | Drug: PlaceboPlacebo, vehicle: administered as a single one-drop dose in each eye at each visit (Day 0 and Day 14). |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- At least 10 years of age
- positive history of ocular allergies
- positive skin test reaction to allergens.
Key exclusion criteria (4 listed)
- known allergy, contraindication, or sensitivities to the use of any of the study medication(s) or their components
- ocular surgical intervention within three (3) months prior to visit 1 or during the study
- known history of retinal detachment, diabetic retinopathy, or progressive retinal disease, or glaucoma
- any other 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 |
|---|---|---|
| alcaftadine0.25% Ophthalmic Solution, one drop in each eye at each of two visits. | Drug | alcaftadine ophthalmic solution |
| PlaceboVehicle without active, one drop in each eye at each of two visits. | Drug | inactive ophthalmic solution vehicle |
Primary outcome
Ocular Itching at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation.
Time frame: Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge
A 0 to 4 scale used, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"; measurement taken at up to 7 minutes following allergen challenge, 16 hours post treatment instillation.
Conjunctival Redness at Visit 3 (Day 0) at 20 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation
Time frame: Visit 3 (Day 0) At 20 minutes following Allergen Challenge, 16 hours post-treatment
A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Ocular Itching at Visit 4 (Day 14) at 7 Minutes Following Allergen Challenge, 15 Minutes Post- Treatment Instillation
Time frame: Visit 4 (Day 14) up to 7 minutes following Allergen Challenge
0 to 4 scale, allowing for half increment scores, where 0 indicates "none" and 4 indicates "incapacitating itch with an irresistible urge to rub"
Conjunctival Redness at Visit 4 (Day 14) at 20 Minutes Following Allergen Challenge, 15 Minutes Post Treatment Instillation
Time frame: Visit 4 (Day 14) At 20 minutes following Allergen Challenge
A 0 to 4 scale used, allowing for half increment scores to measure redness, where 0 indicates "none" and 4 indicates "extremely red"; measurement taken at 20 minutes following allergen challenge, 16 hours post treatment instillation.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21250860Torkildsen G, Shedden A. The safety and efficacy of alcaftadine 0.25% ophthalmic solution for the prevention of itching associated with allergic conjunctivitis. Curr Med Res Opin. 2011 Mar;27(3):623-31. doi: 10.1185/03007995.2010.548797. Epub 2011 Jan 21.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alcaftadine in people with Allergic Conjunctivitis, run by Vistakon Pharmaceuticals 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 3 inclusion and 4 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 2015. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at Visit 3 (Day 0) at 7 Minutes Following Allergen Challenge, 16 Hours After Treatment Instillation. (time frame: Visit 3 (Day 0) 16 hours post-dose, at up to 7 minutes following Allergen Challenge). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00889330, 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 6 Mar 2015.