NCT01988597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

June 10, 2014

Status Verified

June 1, 2014

Enrollment Period

7 months

First QC Date

November 13, 2013

Last Update Submit

June 9, 2014

Conditions

Keywords

Dry EyesQuality of lifeUtility assessment

Outcome Measures

Primary Outcomes (2)

  • • Difference in SPEED Questionnaire and SANDE Questionnaire that affects patient health related quality of life (HRQOL)

    1 day

  • • Difference in both (SPEED and SANDE) questionnaires and utility values that affects patient health related quality of life (HRQOL)

    1 day

Secondary Outcomes (3)

  • Production of Tear flow

    1 day

  • Tear break up time (TBUT)

    1 day

  • Corneal flourescein staining

    1 day

Study Arms (1)

Dry Eyes

Other: Dry eyes

Interventions

Dry Eyes

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • \. Any other specified reason as determined by clinical investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore Eye Research Institute

Singapore, Singapore, 168751, Singapore

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Louis Tong, PhD

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician-Scientist, Senior Consultant

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 20, 2013

Study Start

September 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

June 10, 2014

Record last verified: 2014-06

Locations