Trial Outcomes & Findings for Comparison of Lipiflow®-Treatment and a Standard Lid Hygiene Regime (NCT NCT01769105)
NCT ID: NCT01769105
Last Updated: 2014-10-07
Results Overview
The symptoms of dry eyes are measured in our study with the OSDI and the SPEED questionaire. Primary outcome measure (OSDI) Patients completed two symptom questionnaires: OSDI (Ocular Surface Disease Index) and SPEED (Standard Patient Evaluation of Eye dryness). OSDI scores range from 0 (no symptoms) to 100 (severe symptoms). SPEED scores range from 0 (no symptoms) to 28 (severe symptoms). So a reduction of the OSDI or SPEED score indicates an improvement of subjective dry eye symptoms.
COMPLETED
NA
40 participants
after 3 month compared to baseline value
2014-10-07
Participant Flow
Five patients had been enrolled in the study, but withdrew their participation after baseline examination for personal reasons. They did not receive any treatment.
Participant milestones
| Measure |
Standard Lid Hygiene Regime First, Then Lipiflow
Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow treatment
|
Lipiflow
Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment
|
|---|---|---|
|
First Intervention
STARTED
|
16
|
19
|
|
First Intervention
COMPLETED
|
14
|
17
|
|
First Intervention
NOT COMPLETED
|
2
|
2
|
|
Cross-over
STARTED
|
14
|
0
|
|
Cross-over
COMPLETED
|
9
|
0
|
|
Cross-over
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
| Measure |
Standard Lid Hygiene Regime First, Then Lipiflow
Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow treatment
|
Lipiflow
Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment
|
|---|---|---|
|
First Intervention
Protocol Violation
|
2
|
2
|
|
Cross-over
Lost to Follow-up
|
5
|
0
|
Baseline Characteristics
Comparison of Lipiflow®-Treatment and a Standard Lid Hygiene Regime
Baseline characteristics by cohort
| Measure |
Standard Lid Hygiene Regime First, Then Lipiflow
n=14 Participants
Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily, then a single Lipiflow-treatment
|
Lipiflow
n=17 Participants
Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 19 • n=99 Participants
|
45 years
STANDARD_DEVIATION 23 • n=107 Participants
|
47 years
STANDARD_DEVIATION 21 • n=206 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=99 Participants
|
17 participants
n=107 Participants
|
31 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: after 3 month compared to baseline valueThe symptoms of dry eyes are measured in our study with the OSDI and the SPEED questionaire. Primary outcome measure (OSDI) Patients completed two symptom questionnaires: OSDI (Ocular Surface Disease Index) and SPEED (Standard Patient Evaluation of Eye dryness). OSDI scores range from 0 (no symptoms) to 100 (severe symptoms). SPEED scores range from 0 (no symptoms) to 28 (severe symptoms). So a reduction of the OSDI or SPEED score indicates an improvement of subjective dry eye symptoms.
Outcome measures
| Measure |
Standard Lid Hygiene Regime
n=14 Participants
Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily
|
Lipiflow
n=17 Participants
Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment
|
Cross-over Lipiflow
n=9 Participants
patients received a single Lipiflow treatment after performing lid hygiene for 3 month
|
|---|---|---|---|
|
Change of Dry Eye Symptoms
OSDI 3 month
|
40.0 units on a scale
Standard Deviation 23.4
|
34.6 units on a scale
Standard Deviation 19.6
|
32.8 units on a scale
Standard Deviation 24.4
|
|
Change of Dry Eye Symptoms
SPEED 3 month
|
14.7 units on a scale
Standard Deviation 7.1
|
14.5 units on a scale
Standard Deviation 7.2
|
12.6 units on a scale
Standard Deviation 6.5
|
|
Change of Dry Eye Symptoms
OSDI Baseline
|
40.1 units on a scale
Standard Deviation 16.7
|
46.2 units on a scale
Standard Deviation 14.8
|
39.7 units on a scale
Standard Deviation 23.6
|
|
Change of Dry Eye Symptoms
SPEED Baseline
|
15.9 units on a scale
Standard Deviation 6.6
|
16.8 units on a scale
Standard Deviation 5.6
|
14.7 units on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: after 3 month compared to baseline valuebreak-up-time is measured non-invasive with the Oculus Keratograph 5 M; The break-up-time is measured in seconds. A low break-up-time suggests a lower lipid layer thickness. A higher break-up-time can be regarded as an improvement of ocular surface lubrication.
Outcome measures
| Measure |
Standard Lid Hygiene Regime
n=14 Participants
Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily
|
Lipiflow
n=17 Participants
Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment
|
Cross-over Lipiflow
n=9 Participants
patients received a single Lipiflow treatment after performing lid hygiene for 3 month
|
|---|---|---|---|
|
Change of Break-up-time
Baseline
|
7.7 seconds
Standard Deviation 6.1
|
7.9 seconds
Standard Deviation 8.5
|
6.7 seconds
Standard Deviation 6.1
|
|
Change of Break-up-time
After 3 month
|
7.5 seconds
Standard Deviation 6.1
|
9.9 seconds
Standard Deviation 7.0
|
7.3 seconds
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: after 3 month compared to baseline valueosmolarity is measured with the tear-lab; The osmolarity is measured in mOsm/l. A higher osmolarity can be regarded as an objective sign of dry eye disease. A lower osmolarity after therapy can be regarded as an improvement of ocular surface disease.
Outcome measures
| Measure |
Standard Lid Hygiene Regime
n=14 Participants
Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily
|
Lipiflow
n=17 Participants
Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment
|
Cross-over Lipiflow
n=9 Participants
patients received a single Lipiflow treatment after performing lid hygiene for 3 month
|
|---|---|---|---|
|
Change in Tear Film Osmolarity
Baseline
|
296.7 mOsm/L
Standard Deviation 10.2
|
301.5 mOsm/L
Standard Deviation 11.4
|
305.0 mOsm/L
Standard Deviation 8.7
|
|
Change in Tear Film Osmolarity
After 3 month
|
303.7 mOsm/L
Standard Deviation 8.1
|
307.1 mOsm/L
Standard Deviation 14.0
|
310.0 mOsm/L
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: after 3 month compared to baseline valuelipid layer thickness (LLT) is measured with the Lipiview-interferometer; High values of LLT indicate a better lubrication of the ocular surface, so an increase in LLT can be regarded in an improvement of ocular surface. LLT is measured in Interferometric color units (ICUs) whereas 1 ICU reflects about 1 nm lipid layer thickness.
Outcome measures
| Measure |
Standard Lid Hygiene Regime
n=14 Participants
Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily
|
Lipiflow
n=17 Participants
Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment
|
Cross-over Lipiflow
n=9 Participants
patients received a single Lipiflow treatment after performing lid hygiene for 3 month
|
|---|---|---|---|
|
Change in Lipid Layer Thickness
Baseline
|
44.1 nm
Standard Deviation 7.9
|
43.4 nm
Standard Deviation 9.9
|
45.8 nm
Standard Deviation 21.8
|
|
Change in Lipid Layer Thickness
After 3 month
|
46.4 nm
Standard Deviation 20.8
|
47.4 nm
Standard Deviation 16.7
|
59.2 nm
Standard Deviation 26.3
|
SECONDARY outcome
Timeframe: after 3 month compared to baseline valueexpressible Meibomian glands are measured with the Meibomian gland evaluator; A higher number of expressible Meibomian glands indicate a lower likelihood Meibomian Gland dysfunction.
Outcome measures
| Measure |
Standard Lid Hygiene Regime
n=14 Participants
Patients receive detailed verbal and written instruction to perform lid hygiene twice daily
Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily
|
Lipiflow
n=17 Participants
Patients receive a singe Lipiflow-treatment
Lipiflow: Patients receive a single Lipiflow-treatment
|
Cross-over Lipiflow
n=9 Participants
patients received a single Lipiflow treatment after performing lid hygiene for 3 month
|
|---|---|---|---|
|
Change in Expressible Meibomian Glands
Baseline
|
2.1 number of expressible glands
Standard Deviation 1.3
|
2.5 number of expressible glands
Standard Deviation 1.4
|
4.1 number of expressible glands
Standard Deviation 2.5
|
|
Change in Expressible Meibomian Glands
After 3 month
|
4.6 number of expressible glands
Standard Deviation 3.8
|
5.5 number of expressible glands
Standard Deviation 3.6
|
5.8 number of expressible glands
Standard Deviation 3.2
|
Adverse Events
Standard Lid Hygiene Regime First, Then Lipiflow
Lipiflow
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Finis
Department of ophthalmology, University of Duesseldorf
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place