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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00893243
Other study ID # HSS-01-08
Secondary ID
Status Completed
Phase N/A
First received May 4, 2009
Last updated May 4, 2009

Study information

Verified date May 2009
Source Hospital de Sao Sebastiao
Contact n/a
Is FDA regulated No
Health authority Portugal: National Pharmacy and Medicines Institute
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 27
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Portugal Serviço de Oftalmologia, Hospital de São Sebastião Santa maria da Feira

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Sao Sebastiao

Country where clinical trial is conducted

Portugal, 

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