Efficacy Comparative Study Between Tears Again®, Opticol®... | NCT00893243

Studies
Efficacy Comparative Study Between Tears Again®, Opticol® and Optive®

NCT00893243

Sponsor

Hospital de Sao Sebastiao

Status

Completed

Last Update Posted

May 5, 2009Estimated

Enrollment

27Actual

Phase

Not provided

Conditions

Dry Eye Syndrome

Interventions

Not provided

Countries

Portugal

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

May 2009

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

May 4, 2009

First Submission Date that Met QC Criteria

May 4, 2009

First Posted Date

May 5, 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

May 4, 2009

Last Update Posted Date

May 5, 2009Estimated

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

Primary Purpose:

To compare the efficacy in treating dry eye syndrome in contact lens wearers or computer users of Tears Again® versus Opticol® versus Optive®

Secondary Purpose:

Subjective evaluation of symptomatology
Evaluation of preference in different kind of administration - spray versus monodoses versus multi-doses

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed Consent signed
Age >18 years and < 55 years
Daily wearer of soft contact lens and/or daily (> 4 hours/day) computer user

Exclusion Criteria:

Dry eye Syndrome other than of evaporative etiology, according to DEWS
Ocular or systemic disease that can affect the normal tear film
Pregnancy or pregnancy risk (no contraceptive method), lactation

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Administrative staff of the hospital with more than 4 hours/day computer use and contact lens wearers

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lilianne Duarte, MD	Ophthalmologist	Principal Investigator
José Salgado-Borges, PhD	Ophthalmology Department Director	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Serviço de Oftalmologia, Hospital de São Sebastião		Santa Maria da Feira		4520-211	Portugal

Label	Type	Description	Intervention Names
1Tears Again/Control
2Opticol/Control
3Optive/Control
4Tears Again/Opticol
5Tears Again/Optive
6Opticol/Optive

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases