Efficacy Study of a New Eyedrop on Silicone Hydrogel Cont... | NCT01543061

Studies
Efficacy Study of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints

NCT01543061

Sponsor

Optometric Technology Group Ltd

Status

Completed

Last Update Posted

Sep 27, 2013Estimated

Enrollment

35Estimated

Phase

Phase 4

Conditions

Contact Lens Related Dry Eye Syndrome

Interventions

OPTIVEtm Plus
No treatment
Blink Contacts® Eye Drops

Countries

United Kingdom

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

Sep 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Dec 2012Actual

First Submitted Date

Feb 22, 2012

First Submission Date that Met QC Criteria

Feb 27, 2012

First Posted Date

Mar 2, 2012Estimated

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

Sep 26, 2013

Last Update Posted Date

Sep 27, 2013Estimated

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

Description Module

Brief Summary

The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.

Detailed Description

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

35Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
New study eye drop	Active Comparator	One month of contact lens wear with use of the Test study eye drops	Device: OPTIVEtm Plus
No Eyedrop	Placebo Comparator	One month of contact lens wear with no eye drop use	Procedure: No treatment
BLINK Contacts Lubricating eye drop	Active Comparator	One month of contact lens wear with use of the Control study eye drops	Device: Blink Contacts® Eye Drops

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OPTIVEtm Plus	Device	1 drop in each eye four times a day for a period of 30 (± 3) days	New study eye drop

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Tear Break up Time		30 days

Secondary Outcomes

Measure	Description	Time Frame
Conjunctival staining measurement		30 days
Tear film evaporation rate		30 days
Ocular Surface Disease Index questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Current silicone hydrogel contact lens wearer
Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)

Exclusion criteria:

Known allergy or sensitivity to the study product(s) or its components
Systemic or ocular allergies
Use of systemic medication which might have ocular side effects.
Any ocular infection.
Use of ocular medication.
Significant ocular tissue anomaly

Accepts Healthy Volunteers

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
Michel Guillon, PhD	Optometric Technology Group Ltd	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OTG Research & Consultancy		London		SW1E 6AU	United Kingdom