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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00893243
First Posted: May 5, 2009
Last Update Posted: May 5, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital de Sao Sebastiao
  Purpose

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

Condition
Dry Eye Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Hospital de Sao Sebastiao:

Enrollment: 27
Groups/Cohorts
1Tears Again/Control
2Opticol/Control
3Optive/Control
4Tears Again/Opticol
5Tears Again/Optive
6Opticol/Optive

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Administrative staff of the hospital with more than 4 hours/day computer use and contact lens wearers
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00893243


Locations
Portugal
Serviço de Oftalmologia, Hospital de São Sebastião
Santa maria da Feira, Portugal, 4520-211
Sponsors and Collaborators
Hospital de Sao Sebastiao
Investigators
Principal Investigator: Lilianne Duarte, MD Ophthalmologist
Study Director: José Salgado-Borges, PhD Ophthalmology Department Director
  More Information

Responsible Party: Dr Lilianne Duarte, MD, Ophthalmologist
ClinicalTrials.gov Identifier: NCT00893243     History of Changes
Other Study ID Numbers: HSS-01-08
First Submitted: May 4, 2009
First Posted: May 5, 2009
Last Update Posted: May 5, 2009
Last Verified: May 2009

Additional relevant MeSH terms:
Syndrome
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Disease
Pathologic Processes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases