Use of Loteprednol for Contact Lens Intolerance and Dryness | NCT00817557

Studies
Use of Loteprednol for Contact Lens Intolerance and Dryness

NCT00817557

Sponsor

Hom, Milton M., OD, FAAO

Status

Unknown status

Last Update Posted

Jan 6, 2009Estimated

Enrollment

25Estimated

Phase

Phase 4

Conditions

Contact Lenses Dryness

Interventions

Loteprednol
Rewetter

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2009

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

Jan 2009

Primary Completion Date

Jun 2009Estimated

Completion Date

Sep 2009Estimated

First Submitted Date

Jan 2, 2009

First Submission Date that Met QC Criteria

Jan 5, 2009

First Posted Date

Jan 6, 2009Estimated

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

Jan 5, 2009

Last Update Posted Date

Jan 6, 2009Estimated

Name	Class
Bausch & Lomb Incorporated	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

25Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Loteprednol	Active Comparator	Loteprednol BID	Drug: Loteprednol
Rewetter	Placebo Comparator	Rewetter BID	Other: Rewetter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Loteprednol	Drug	Anti-inflammatory	Loteprednol
Rewetter

Measure	Description	Time Frame
Wearing time		28 days

Measure	Description	Time Frame
OSDI		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Between the ages of 18 and over inclusive.
Males or females
Any race or ethnic background
CL history- experienced intolerance and either switched solutions or lenses without satisfactory relief.
Patient is in generally good & stable overall health.
Patient likely to comply with study guidelines & study visits.
Informed consent signed.
OSDI score 18 or higher while wearing lenses
Unsatisfactory wearing time with contact lenses

Exclusion Criteria:

Corneal refractive surgery within 6 months of this study.
Contact lens use on day of examination.
Corneal ectasia.
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

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

Type	Date	Date Unknown
Release	Oct 5, 2010
Reset	Nov 4, 2010

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 5, 2010			Nov 4, 2010

Intervention Browse Module

MeSH Terms

ID	Term
D000069559	Loteprednol Etabonate

Ancestor Terms

ID	Term
D000730	Androstadienes
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473

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