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Dry Eye Symptoms and Quality of Life

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. Identifier: NCT01988597
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : June 10, 2014
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

Brief Summary:
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 or disease Intervention/treatment
Dry Eyes Other: Dry eyes

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Dry Eye Symptoms and Quality of Life
Study Start Date : September 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Group/Cohort Intervention/treatment
Dry Eyes Other: Dry eyes

Primary Outcome Measures :
  1. • Difference in SPEED Questionnaire and SANDE Questionnaire that affects patient health related quality of life (HRQOL) [ Time Frame: 1 day ]
  2. • Difference in both (SPEED and SANDE) questionnaires and utility values that affects patient health related quality of life (HRQOL) [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Production of Tear flow [ Time Frame: 1 day ]
  2. Tear break up time (TBUT) [ Time Frame: 1 day ]
  3. Corneal flourescein staining [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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.

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 identifier (NCT number): NCT01988597

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

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Responsible Party: Louis Tong, Clinician-Scientist, Senior Consultant, Singapore National Eye Centre Identifier: NCT01988597     History of Changes
Other Study ID Numbers: R1047/62/2013
2013/595/A ( Other Identifier: SingHealth Centralised Institutional Review Board )
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: June 10, 2014
Last Verified: June 2014

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

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