Conjunctivitis, AllergicPhase 4NCT01732757
A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis
A Phase 4 study testing Alcaftadine 0.25%, Olopatadine 0.2% and dextran 70 0.1%/hydroxypropyl methylcellulose 0.3% in people with Conjunctivitis, Allergic, run by Allergan at 1 site in United States.
Trial summary
This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Conjunctivitis, Allergic
- What is being tested?
- Alcaftadine 0.25%, Olopatadine 0.2% and dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Dec 2012
- Phase
- Phase 4
- 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
- History of ocular allergies within the past 24 months.
- Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.
Who cannot join
- Any presence of active ocular infection or history of an ocular herpetic infection.
- Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.
- Have any planned surgery during the study or 30 days after the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.
- Conditions
- Conjunctivitis, Allergic
- Being tested
- Alcaftadine 0.25%, Olopatadine 0.2%, dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcaftadine 0.25%Drug
Also called Lastacaft®
One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
Olopatadine 0.2%Drug
Also called Pataday™
One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%Drug
Also called Tears Naturale II
One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Lastacaft® | Active comparator | One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0. Receives: Drug: Alcaftadine 0.25% |
| Pataday™ | Active comparator | One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0. Receives: Drug: Olopatadine 0.2% |
| Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) | Placebo comparator | One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0. Receives: Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0
Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.
Measured: Day 0 at 3 Minutes Post Challenge
Secondary outcomes (10)
Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0
Ocular itching is evaluated by the subject at 5 and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.
Measured: Day 0
Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0
Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Minimal itching is considered a score <1.
Measured: Day 0
Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0
Ocular itching is evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). Zero itch is considered a score = 0.
Measured: Day 0
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0
Ocular itching is evaluated by the subject at Hour 16 post challenge on Day 0. Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed).
Measured: Day 0
Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
The conjunctiva is a thin membrane that covers the inner surface of the eyelid and the white part of the eye. Conjunctival redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score conjunctival redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less conjunctival redness.
Measured: Day 0
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Ciliary redness is redness spreading out around the cornea of the eye. Ciliary redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score ciliary redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less ciliary redness.
Measured: Day 0
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
The episclera is the tissue that lies over the white part of the eye. Episcleral redness is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score episcleral redness on a 9-point numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less episcleral redness.
Measured: Day 0
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Chemosis is swelling of the tissue that lines the eyelids and surface of the eye. Chemosis is evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Investigators score chemosis on a 9-point numeric analog scale ranging from 0=None to 4=Severe (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less chemosis.
Measured: Day 0
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
Eyelid swelling is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score eyelid swelling on a 4-point numeric analog scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less lid swelling.
Measured: Day 0
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
Tearing is evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 0 (Visit 3B). Subjects score tearing on a 5-point numeric analog scale ranging from 0=None/Normal to 4=Very Severe. For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less tearing.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
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 Conjunctivitis, AllergicStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732757
- Sponsor's protocol ID
- GMA-LAS-12-023
- Status last verified
- Nov 2013
- First submitted
- 19 Nov 2012
- Last updated
- 14 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
McLaurin EB, Marsico NP, Ackerman SL, Ciolino JB, Williams JM, Villanueva L, Hollander DA. Ocular itch relief with alcaftadine 0.25% versus olopatadine 0.2% in allergic conjunctivitis: pooled analysis of two multicenter randomized clinical trials. Adv Ther. 2014 Oct;31(10):1059-71. doi: 10.1007/s12325-014-0155-3. Epub 2014 Sep 27.
PubMed 25260889
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Efficacy of Lastacaft® Compared to Pataday™ and Placebo in Patients With Acute Allergic Conjunctivitis
- ClinicalTrials.gov ID
- NCT01732757
- Acronym / sponsor ID
- GMA-LAS-12-023
- Conditions
- Conjunctivitis, Allergic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Posted 14 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy of Lastacaft® (Alcaftadine 0.25%) and Pataday™ (Olopatadine 0.2%) as compared to each other and to placebo in the prevention of ocular itching associated with allergic conjunctivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lastacaft® | Active comparator | Drug: Alcaftadine 0.25%One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0. |
| Pataday™ | Active comparator | Drug: Olopatadine 0.2%One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0. |
| Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) | Placebo comparator | Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- History of ocular allergies within the past 24 months.
- Able to avoid wearing contact lenses for at least 72 hours prior to and during the study trial period.
Key exclusion criteria (3 listed)
- Any presence of active ocular infection or history of an ocular herpetic infection.
- Ocular surgery within 3 months prior to the first visit or refractive surgery within the past 6 months.
- Have any planned surgery during the study or 30 days after the study.
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 |
|---|---|---|
| Alcaftadine 0.25%Also: Lastacaft®One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0. | Drug | Lastacaft® |
| Olopatadine 0.2%Also: Pataday™One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0. | Drug | Pataday™ |
| dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%Also: Tears Naturale IIOne drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0. | Drug | Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) |
Primary outcome
Ocular Itching Evaluated by the Subject 3 Minutes Post Challenge on Day 0
Time frame: Day 0 at 3 Minutes Post Challenge
Ocular itching is evaluated by the subject at 3 minutes post challenge on Day 0 (Visit 3B). Subjects score their ocular itching on a 9-point numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments are allowed). For each subject, the score for both eyes is averaged (i.e., one score per subject). A lower score is indicative of less itching.
10 secondary outcomes
Ocular Itching Evaluated by the Subject at 5 and 7 Minutes Post Challenge on Day 0
Time frame: Day 0
Percentage of Subjects With Minimal Itching Score at 3, 5, and 7 Minutes Post Challenge on Day 0
Time frame: Day 0
Percentage of Subjects With a Zero Itch Score at 3, 5, and 7 Minutes Post Challenge on Day 0
Time frame: Day 0
Percentage of Subject Eyes in Each Category of the Itching Score Distribution Post Challenge on Day 0
Time frame: Day 0
Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Time frame: Day 0
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Time frame: Day 0
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Time frame: Day 0
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 0
Time frame: Day 0
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
Time frame: Day 0
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 0
Time frame: Day 0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25260889McLaurin EB, Marsico NP, Ackerman SL, Ciolino JB, Williams JM, Villanueva L, Hollander DA. Ocular itch relief with alcaftadine 0.25% versus olopatadine 0.2% in allergic conjunctivitis: pooled analysis of two multicenter randomized clinical trials. Adv Ther. 2014 Oct;31(10):1059-71. doi: 10.1007/s12325-014-0155-3. Epub 2014 Sep 27.
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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.
Medical Director study director
Allergan
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 Alcaftadine 0.25%, Olopatadine 0.2% and dextran 70 0.1%/hydroxypropyl methylcellulose 0.3% in people with Conjunctivitis, Allergic, run by Allergan 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 2 inclusion and 3 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 14 Jan 2014. 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 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?
Yes. Results are posted in the registry (first posted 14 Jan 2014). 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 Evaluated by the Subject 3 Minutes Post Challenge on Day 0 (time frame: Day 0 at 3 Minutes Post Challenge). 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 NCT01732757, 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 14 Jan 2014.