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

May 4, 2009 updated by: Hospital de Sao Sebastiao

Efficacy Comparative Study Between Tears Again®, o Opticol® e o Optive® in Clinical and Symptomatology Treatment of Dry Eye Syndrome in Contact Lens Wearers and/or Computers Users

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Santa maria da Feira, Portugal, 4520-211
        • Serviço de Oftalmologia, Hospital de São Sebastião

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1Tears Again/Control
2Opticol/Control
3Optive/Control
4Tears Again/Opticol
5Tears Again/Optive
6Opticol/Optive

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Sao Sebastiao

Investigators

  • Principal Investigator: Lilianne Duarte, MD, Ophthalmologist
  • Study Director: José Salgado-Borges, PhD, Ophthalmology Department Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 4, 2009

First Submitted That Met QC Criteria

May 4, 2009

First Posted (ESTIMATE)

May 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

May 5, 2009

Last Update Submitted That Met QC Criteria

May 4, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSS-01-08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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