Conjunctivitis, AllergicPhase 4NCT01470118

A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis

A Phase 4 study testing alcaftadine 0.25% ophthalmic solution, olopatadine 0.2% ophthalmic solution and dextran 70 0.1%/hydroxypropyl methylcellulose 0.3% in people with Conjunctivitis, Allergic, run by Allergan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (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% ophthalmic solution, olopatadine 0.2% ophthalmic solution and dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 127 participants
Where: 1 siteUnited States
Study dates: Oct 2011to Dec 2011
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 eye allergies within the past 24 months
Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period

Who cannot join

Current eye infection
Eye surgery within 3 months or vision correction surgery within 6 months
Any planned surgery during the study or 30 days after the study

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Philadelphia, Pennsylvania

Other trials in United States

About this study

This study will evaluate the duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (placebo) in the prevention of ocular itching associated with allergic conjunctivitis.

Conditions: Conjunctivitis, Allergic
Being tested: alcaftadine 0.25% ophthalmic solution, olopatadine 0.2% ophthalmic solution, 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% ophthalmic solutionDrug
Also called LASTACAFT®
One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
olopatadine 0.2% ophthalmic solutionDrug
Also called Pataday™
One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%Drug
Also called Tears Naturale® II Artificial Tears
One drop of placebo instilled in each eye at Day 0 and Day 14.

Study groups in NCT01470118
Study group	Role	What they receive
LASTACAFT® (alcaftadine 0.25%)	Active comparator	One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14. Receives: Drug: alcaftadine 0.25% ophthalmic solution
Pataday™ (olopatadine 0.2%)	Active comparator	One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14. Receives: Drug: olopatadine 0.2% ophthalmic solution
Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)	Placebo comparator	One drop of placebo instilled in each eye at Day 0 and Day 14. 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 at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.
Measured: Day 0 Hour 16
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.
Measured: Day 14 Hour 24

Secondary outcomes (6)

Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Conjunctival redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored conjunctival redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less conjunctival redness.
Measured: Day 14 Hour 24
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Ciliary redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored ciliary redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less ciliary redness.
Measured: Day 14 Hour 24
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Episcleral redness evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored episcleral redness on a numeric analog scale ranging from 0=None to 4=Extremely Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less episcleral redness.
Measured: Day 14 Hour 24
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Chemosis evaluated by the investigator at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Investigators scored chemosis on a numeric analog scale ranging from 0=None to 4=Severe (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less chemosis.
Measured: Day 14 Hour 24
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Eyelid swelling evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored eyelid swelling on a numeric analog 4-point scale ranging from 0=None to 3=Severe. For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less lid swelling.
Measured: Day 14 Hour 24
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Tearing evaluated by the subject at 7, 15, and 20 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored 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 was averaged (i.e., one score per subject). A lower score was indicative of less tearing.
Measured: Day 14 Hour 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2011Dec 2011

First posted11 Nov 2011 (estimated)
Study startOct 2011
Primary completionDec 2011
Study completionDec 2011

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: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01470118
Sponsor's protocol ID: GMA-LAS-011-001
Status last verified: Jan 2013
First submitted: 9 Nov 2011
Last updated: 21 Feb 2013
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Conjunctivitis, Allergic trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Duration of LASTACAFT® in Acute Allergic Conjunctivitis
ClinicalTrials.gov ID: NCT01470118
Acronym / sponsor ID: GMA-LAS-011-001
Conditions: Conjunctivitis, Allergic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: AllerganIndustry (pharma, biotech, devices)
Study start: Oct 2011
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 11 Nov 2011 (estimated)
Results: Posted 21 Feb 2013

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 duration of action of LASTACAFT® and Pataday™ as compared to artificial tears (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® (alcaftadine 0.25%)	Active comparator	Drug: alcaftadine 0.25% ophthalmic solutionOne drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
Pataday™ (olopatadine 0.2%)	Active comparator	Drug: olopatadine 0.2% ophthalmic solutionOne drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)	Placebo comparator	Drug: dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%One drop of placebo instilled in each eye at 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 (2 listed)

History of eye allergies within the past 24 months
Willing to not wear contact lenses at least 72 hours prior to the study start and during the study period

Key exclusion criteria (3 listed)

Current eye infection
Eye surgery within 3 months or vision correction surgery within 6 months
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% ophthalmic solutionAlso: LASTACAFT®One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.	Drug	LASTACAFT® (alcaftadine 0.25%)
olopatadine 0.2% ophthalmic solutionAlso: Pataday™One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.	Drug	Pataday™ (olopatadine 0.2%)
dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%Also: Tears Naturale® II Artificial TearsOne drop of placebo instilled in each eye at Day 0 and Day 14.	Drug	Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%)

Primary outcome

Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16
Time frame: Day 0 Hour 16
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 0 (Visit 3) at hour 16. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.
Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24
Time frame: Day 14 Hour 24
Ocular itching evaluated by the subject at 3, 5, and 7 minutes post challenge on Day 14 (Visit 4) at hour 24. Subjects scored their ocular itching on a numeric analog scale ranging from 0=None to 4=Incapacitating Itch with an Irresistible Urge to Rub (0.5 increments were allowed). For each subject, the score for both eyes was averaged (i.e., one score per subject). A lower score was indicative of less itching.

6 secondary outcomes

Conjunctival Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Time frame: Day 14 Hour 24
Ciliary Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Time frame: Day 14 Hour 24
Episcleral Redness Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Time frame: Day 14 Hour 24
Chemosis Evaluated by the Investigator at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Time frame: Day 14 Hour 24
Eyelid Swelling Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Time frame: Day 14 Hour 24
Tearing Evaluated by the Subject at 7, 15, and 20 Minutes Post Challenge on Day 14 at Hour 24
Time frame: Day 14 Hour 24

Results and safety

Results posted to the registry on 21 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LASTACAFT® (Alcaftadine 0.25%)	43	38
Pataday™ (Olopatadine 0.2%)	43	38
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)	41	39

Primary outcome: Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16

Time frame: Day 0 Hour 16. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	LASTACAFT® (Alcaftadine 0.25%) n = 43	Pataday™ (Olopatadine 0.2%) n = 43	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n = 41
3 Minutes	0.62 (0.716)	1.01 (0.8211)	2.14 (0.864)
5 Minutes	0.93 (0.789)	1.13 (0.852)	2.35 (0.759)
7 Minutes	1.07 (0.830)	1.12 (0.824)	2.20 (0.888)

Population analysed: Intent-to-Treat: All randomized subjects

Primary outcome: Ocular Itching Evaluated by the Subject at 3, 5, and 7 Minutes Post Challenge on Day 14 at Hour 24

Time frame: Day 14 Hour 24. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	LASTACAFT® (Alcaftadine 0.25%) n = 43	Pataday™ (Olopatadine 0.2%) n = 43	Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%) n = 41
3 Minutes	0.64 (0.807)	0.97 (0.771)	2.27 (0.846)
5 Minutes	0.84 (0.851)	1.16 (0.886)	2.19 (0.897)
7 Minutes	0.93 (0.911)	1.01 (0.932)	1.96 (1.068)

Population analysed: Intent-to-Treat: All randomized subjects

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LASTACAFT® (Alcaftadine 0.25%)	0 of 43 (0%)	0 of 43 (0%)	Not reported
Pataday™ (Olopatadine 0.2%)	0 of 42 (0%)	0 of 42 (0%)	Not reported
Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)	0 of 41 (0%)	0 of 41 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2013.
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.

Related trials for Conjunctivitis, Allergic

RecruitingPhase 3
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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?

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 21 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 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 21 Feb 2013). 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 at 3, 5, and 7 Minutes Post Challenge on Day 0 at Hour 16 (time frame: Day 0 Hour 16). 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?

On the ClinicalTrials.gov record for NCT01470118, 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 21 Feb 2013.