Comparison of Tolerability Between Two Allergy Drops | NCT01390961

Studies
Comparison of Tolerability Between Two Allergy Drops

NCT01390961

Sponsor

Hom, Milton M., OD, FAAO

Status

Unknown status

Last Update Posted

Jul 11, 2011Estimated

Enrollment

48Estimated

Phase

Phase 4

Conditions

Allergic Conjunctivitis

Interventions

alacaftadine and naphazoline HCl & pheniramine maleate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Jul 7, 2011

First Submission Date that Met QC Criteria

Jul 7, 2011

First Posted Date

Jul 11, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2011

Last Update Posted Date

Jul 11, 2011Estimated

Name	Class
Allergan	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
alacaftadine and naphazoline HCl & pheniramine maleate	Drug	once a day		Lastacaft Opcon A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tolerability	Tolerability measured by questionnaire Visual Analog scale 1 to 100	8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Months

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Milton M. Hom, OD, FAAO.		Azusa	California	91702	United States

Condition Browse Module

MeSH Terms

ID	Term
D003233	Conjunctivitis, Allergic

Ancestor Terms

ID	Term
D003231	Conjunctivitis
D003229	Conjunctival Diseases
D005128	Eye Diseases
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009278	Naphazoline
D010632	Pheniramine
C557708	alcaftadine
C116502	Naphcon A

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided