Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT01988597 |
| Other study ID # |
R1047/62/2013 |
| Secondary ID |
2013/595/A |
| Status |
Completed |
| Phase |
N/A
|
| First received |
November 13, 2013 |
| Last updated |
June 9, 2014 |
| Start date |
September 2013 |
| Est. completion date |
April 2014 |
Study information
| Verified date |
June 2014 |
| Source |
Singapore National Eye Centre |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Singapore: Health Sciences Authority |
| Study type |
Observational
|
Clinical Trial 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.
Description:
Dry eye is a multifactorial condition that affects 5-35% of the population.1 Common symptoms
of this condition include eye irritation, heaviness of the eyelids, visual disturbances,
tearing and light sensitivity.2 This condition significantly decrease patient health related
quality of life (HRQOL). Clinical studies shown poor correlation between clinical test
symptoms and self perceived severity of the disease.7 Studies also have shown that utilities
of more severe dry eye similar to condition such as class III/IV angina affecting the QOL.6
Correlation between reduce quality of life and presenting symptoms is unknown compared to
other factors such as cost and inconvenience of treatment. This implicates on the management
of the condition. In addition, there is a significant socioeconomic burden. In 2009, 54,051
patients sought treatment for dry eye in the Singapore National Eye Centre (SNEC). In total,
the costs for dry eye medication amounted to $181,354.17.4
Although different questionnaires have been used in assessment of dry eye, to date, there
has been no study which evaluates the extent of questionnaires correlate with change in
quality of life.
This is particularly important since symptoms of dry eyes are episodic and questionnaires
administered at one time point may or may not reflect the true disease morbidity. Two of
such questionnaires are the SPEED questionnaires which consist of 2 questions graded on a
scale of 0-3 on frequency and grade 0-4 on severity and SANDE questionnaires which consist
of 3 questions based on symptoms of frequency and severity.
Both of the questionnaires have been published and validated and utilized in the eye clinic
by the investigators.
Over the last few years, SNEC/SERI has built up a dedicated team of dry eye researchers for
trials and evaluation of diagnostic devices. There is an increasing interest
internationally, especially from industry, to partner us for testing of commercial products.
Clinical importance Dry eye is a common and growing public health problem with significant
morbidity and decrease in health related quality of life. Uncertainty in correlation between
decrease quality of life with presenting symptoms and factors such as cost and inconvenience
of treatment may implicate the management of the disease. For instance, if presenting
symptoms correlate poorly with the perceived quality of life, more emphasis should be placed
on making treatment more accessible and convenient. If there is a high correlation, the
focus should be making current treatments more efficacious to relieve presenting symptoms.
The findings of this study will help us to decide the efficacy of the questionnaires use in
future clinical trials in our centre.
Study Objectives and Purpose
1. To determine if the symptoms of dry eye assessed by the SPEED questionnaire correlate
with utility values (HRQOL)
2. To determine if the symptoms of dry eye assessed by the SANDE questionnaire correlate
with utility values (HRQOL)
3. To evaluate if the extent of correlation with HRQOL differs significantly between SPEED
and SANDE questionnaires
Study design:
Prospective cross-sectional interview study
Rationale Dry eye disease defined by The National Eye Institute Workshop as tear
deficiency and excessive tear evaporation that causes damage to the ocular surface and
is associated with symptoms and ocular discomfort.5 These symptoms causes adverse
effect on quality of life (HRQL) of patients resulting in inappropriate management. In
order to achieve a better correlation between dry eye symptoms and quality of life,
investigators aim to distinguish a sensitive quantitative tool.
Methods Interviewers who passed CITI will be trained in conducting the questionnaires
to assess patients' quality of life and utility values. A set guidelines will be taught
to prevent inter-examiner variability.
Participants and target sample size 200 symptomatic patients will be recruited for this
study from the dry eye clinic in SNEC. 100 patients from dry eye clinic in SNEC will be
assessed with SPEED and utility assessment, and another 100 patients from dry eye
clinic in SNEC will be assessed with SANDE and utility assessment.
Visit schedules Basic eye assessments and interviewer-assisted questionnaires will be
done on the same day. There will be no repeat visits required.
Duration of study:
One year
Procedures:
Assessment of Dry Eye Symptoms Basic biodata such as age, race, gender be recorded.
• Tear break up time (TBUT) A drop of normal saline will be instilled on a fluorescein
strip (Fluorets) then shaken off so that no visible drop remains. The subject is asked
to look up before introduction of the fluoret into the inferior conjunctival fornix on
the right then left eye.
The participant will blink a few times and close the eyes for few seconds. The
participant will then be asked to open the eyes, look ahead at the observer's forehead
and not blink for as long as possible. The break up time is defined as the time between
the lid opening and the first appearance of any dry spot on the cornea. The participant
will be requested to close his eyes for few seconds and the procedure will be repeated
for the left eye. Three reading will be taken and averaged
Corneal fluorescein staining score Assessment of positive fluorescein staining will be
assessed after recording TBUT. A scoring system will be applied as previously published
by Barr et al. (Barr 1999). Briefly, there will be 5 corneal zones and 4 conjunctival
regions as shown in Figure 1. The staining scale is 0-4, with 0.5 unit steps in each of
the zones. The 'total' staining score will also be averaged.
• Schirmers I test This will be done with the standard strips currently used at SERI (5
mm wide with a notch for folding) (Sno strips, Bausch & Lomb, France) without
anaesthetic. The strips will be positioned over the inferior temporal half of the lower
lid margin in both eyes at the same time.The study participant will be asked to close
their eyes during the test. Any excessive irritation signs or reflex tearing will be
noted.
Dry eye Questionnaires Participants will be asked to score and fill up a dry eye
questionnaire that assesses the symptomatic severity of dry eyes in the participant and
the extent of its disruption to daily activities for the past one month.
Two different questionnaires and utility assessment will be administered in the study;
- SPEED Questionnaire Consist of 2 questions on frequency and severity graded on a
scale of 0-3 on frequency and grade 0-4 on severity. The questionnaire allows
patient to rate from 0 which is never and 3 which is all the time in frequency and
0 as no problem and 4 as intolerable in severity.
- SANDE Questionnaire Consist of 3 questions on frequency and severity. VAS will be
applied to evaluate dry eye symptoms as described by Schaumberg et al.
(Schaumberg, Gulati et al. 2007). As shown in Appendix A (question 1 to 3), the
scores will be recorded separately for frequency and severity of dry eye
symptoms., patients will be asked to mark "X" on a 100mm line that corresponds to
the degree of the symptom. A global score will be calculated by multiplying the
frequency score by the severity score and taking the square root of the result (to
transform back to the original scale).
- Utility assessment Investigators will be using Time trade-off method in this
study, as approved by IRB and was used in Thermal pulsation system for treatment
of Meibomian Gland Dysfunction study (CRIB no: 2012/191/A). In addition, questions
on socioeconomics will be administered to the patients.
Statistics:
Sample size calculation There will be no interim analysis. Analysis will be performed
after all the subjects have completed the questionnaires or have withdrawn from the
study. The distributions of the scores will be examined by histograms for normality.
Pearson correlation coefficients (r) will be calculated between SPEED score (x) and
utility value (y) for these 2 groups of patients.
Confidence intervals will be calculated at 95% confidence level. The confidence limits
are computed as;
Expected outcomes:
Primary Outcome
- Difference in SPEED Questionnaire and SANDE Questionnaire that affects patient
health related quality of life (HRQOL)
- Difference in both (SPEED and SANDE) questionnaires and utility values that
affects patient health related quality of life (HRQOL)
Secondary Outcomes
- Schirmers I reading
- Tear break up time (TBUT)
- Corneal fluorescein staining
Potential problems As the 2 questionnaires used are in English and there are no
validated translated questionnaires, we are limited to patients who are
English-educated only. For simplicity of using validated questionnaires, we would be
concentrating on English-educated patients for this study.
Dry eye signs correlate poorly with symptoms and patient may not have an understanding
of their true conditions making it more difficult to obtain accurate score. In our
conservative population, sensitive questions on utility may distress the patients and
therefore inability to answer the questions appropriately.
