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

NCT ID: NCT00893243

Last Updated: 2009-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Brief Summary

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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

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Conditions

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Dry Eye Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1Tears Again/Control

No interventions assigned to this group

2Opticol/Control

No interventions assigned to this group

3Optive/Control

No interventions assigned to this group

4Tears Again/Opticol

No interventions assigned to this group

5Tears Again/Optive

No interventions assigned to this group

6Opticol/Optive

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Sao Sebastiao

OTHER

Sponsor Role lead

Responsible Party

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MD, Ophthalmologist

Principal Investigators

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Lilianne Duarte, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmologist

José Salgado-Borges, PhD

Role: STUDY_DIRECTOR

Ophthalmology Department Director

Locations

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Serviço de Oftalmologia, Hospital de São Sebastião

Santa Maria da Feira, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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HSS-01-08

Identifier Type: -

Identifier Source: org_study_id

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