Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Hospital de Sao Sebastiao
ClinicalTrials.gov Identifier:
NCT00893243
First received: May 4, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted

May 4, 2009
May 4, 2009
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy Comparative Study Between Tears Again®, Opticol® and Optive®
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
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Dry Eye Syndrome
Not Provided
  • 1Tears Again/Control
  • 2Opticol/Control
  • 3Optive/Control
  • 4Tears Again/Opticol
  • 5Tears Again/Optive
  • 6Opticol/Optive
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
Not Provided
Not Provided

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
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT00893243
HSS-01-08
No
Dr Lilianne Duarte, MD, Ophthalmologist
Hospital de Sao Sebastiao
Not Provided
Principal Investigator: Lilianne Duarte, MD Ophthalmologist
Study Director: José Salgado-Borges, PhD Ophthalmology Department Director
Hospital de Sao Sebastiao
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP