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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
  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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr Lilianne Duarte, MD, Ophthalmologist
ClinicalTrials.gov Identifier: NCT00893243     History of Changes
Other Study ID Numbers: HSS-01-08
Study First Received: May 4, 2009
Last Updated: May 4, 2009
Health Authority: Portugal: National Pharmacy and Medicines Institute

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

ClinicalTrials.gov processed this record on November 20, 2014