Dry Eye Symptoms and Quality of Life

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT01988597
First received: November 13, 2013
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

Dry eye syndrome is a very common condition with multiple etiologies that includes systemic and ocular disease that causes reduction in the production of tears, as well as increase in tears evaporation. As a result of the various etiologies and large variability of dry eye's clinical sign, it has been a challenge for practitioners to have a consistent system to classify dry eyes and to have an appropriate and accurate measurement to quantify the severity of dry eyes and its impact on patients' quality of life.6 To date, no study which evaluates the extent of questionnaires correlates with changes in quality of life. With this cross sectional interview study, we aim to determine the efficacy of the questionnaires as a practical tool in our future clinical trials at our center.


Condition Intervention
Dry Eyes
Other: Dry eyes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Dry Eye Symptoms and Quality of Life

Resource links provided by NLM:


Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • • Difference in SPEED Questionnaire and SANDE Questionnaire that affects patient health related quality of life (HRQOL) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • • Difference in both (SPEED and SANDE) questionnaires and utility values that affects patient health related quality of life (HRQOL) [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Production of Tear flow [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Tear break up time (TBUT) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Corneal flourescein staining [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: September 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The study population will be recruited from Dry Eye Clinic at Singapore National Eye Center.

Criteria

Inclusion Criteria:

  1. Age of 21 years old and above and has full legal capacity to volunteer
  2. Patients able to understand and complete 2 English questionnaires. 
  3. Symptomatic dry eye patient

Exclusion Criteria:

1. Any other specified reason as determined by clinical investigator.

  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: NCT01988597

Locations
Singapore
Singapore Eye Research Institute
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
Principal Investigator: Louis Tong, PhD Singapore National Eye Centre
  More Information

No publications provided

Responsible Party: Louis Tong, Clinician-Scientist, Senior Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT01988597     History of Changes
Other Study ID Numbers: R1047/62/2013, 2013/595/A
Study First Received: November 13, 2013
Last Updated: June 9, 2014
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore National Eye Centre:
Dry Eyes
Quality of life
Utility assessment

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

ClinicalTrials.gov processed this record on July 29, 2014