Trial Outcomes & Findings for Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (NCT NCT01089608)
NCT ID: NCT01089608
Last Updated: 2014-11-04
Results Overview
The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
Baseline and D63 (D63 minus baseline)
Results posted on
2014-11-04
Participant Flow
Participant milestones
| Measure |
Unifluid
Eye drops in Single Dose Unit
Povidone: Eye drops Single dose unit
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
|
Azithromycin
Eye drops Single dose unit
Azithromycin: Eye drops, Dosage : 1.5%
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
50
|
|
Overall Study
COMPLETED
|
43
|
44
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
Unifluid
Eye drops in Single Dose Unit
Povidone: Eye drops Single dose unit
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
|
Azithromycin
Eye drops Single dose unit
Azithromycin: Eye drops, Dosage : 1.5%
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis
Baseline characteristics by cohort
| Measure |
Unifluid
n=43 Participants
Eye drops in Single Dose Unit
Povidone: Eye drops Single dose unit
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
|
Azithromycin
n=50 Participants
Eye drops Single dose unit
Azithromycin: Eye drops, Dosage : 1.5%
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 16.2 • n=5 Participants
|
55.7 years
STANDARD_DEVIATION 16.1 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 16.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and D63 (D63 minus baseline)Population: Modified ITT set: all randomised patients with at least one eligible treated eye, for whom any follow-up efficacy data are available.
The primary objective is to evaluate the efficacy of the treatment by the change from baseline (Day 0) to Day 63 (± 3 Days) of the global ocular discomfort (Visual Analogue Scale) (Decrease of VAS value = better outcome)
Outcome measures
| Measure |
Unifluid
n=43 Participants
Eye drops in Single Dose Unit
Povidone: Eye drops Single dose unit
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
|
Azithromycin
n=50 Participants
Eye drops Single dose unit
Azithromycin: Eye drops, Dosage : 1.5%
1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times.
|
|---|---|---|
|
Visual Analogue Scale (VAS - Ranges 0-100 mm)
|
36.5 units on a scale (from 0 to 100 mm)
Interval 30.5 to 42.4
|
28.5 units on a scale (from 0 to 100 mm)
Interval 22.7 to 34.3
|
Adverse Events
Unifluid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Azithromycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All the results of the Trial are the sole and exclusive property of THEA, and cannot be used in whatever form without prior written agreement of THEA.
- Publication restrictions are in place
Restriction type: OTHER