Comparison of Tolerability and Clinical Performance of Tw... | NCT01335126

Studies
Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears

NCT01335126

Sponsor

Hom, Milton M., OD, FAAO

Status

Unknown status

Last Update Posted

Apr 14, 2011Estimated

Enrollment

48Estimated

Phase

Phase 3

Conditions

Dry Eye

Interventions

Emulsion type artificial tear

Countries

Not provided

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

Apr 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

Mar 2011

Primary Completion Date

Oct 2011Estimated

Completion Date

Nov 2011Estimated

First Submitted Date

Apr 12, 2011

First Submission Date that Met QC Criteria

Apr 13, 2011

First Posted Date

Apr 14, 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

Apr 13, 2011

Last Update Posted Date

Apr 14, 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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test	Experimental		Other: Emulsion type artificial tear

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emulsion type artificial tear	Other	2 types of artificial tears	Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tolerability Questionnaire	Tolerability (comfort) measured with Visual Analog scale (1 to 100)	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Acceptability Questionnaire	Acceptability questionnaire on statements regarding drop satisfaction, etc. Answered as A to E (Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree)	8 weeks
Tear Break Up Time

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.
OSDI score >18 OR
TBUT <10 seconds

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 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Milton M Hom, OD FAAO	Private Practice	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided