Blepharitis
Conditions
Keywords
Azyter in patients affected by chronic blepharitis.
Brief summary
The primary objective of this study is to demonstrate the efficacy of T1225 eye drops versus placebo eye drops on the global ocular discomfort (VAS).
Detailed description
Currently, topical antibiotic ointments are used for blepharitis. They provide prolonged contact time with the lid margin but with little penetration into eyelid tissue. Azithromycin eye drops may offer on advantage over these preparations because azithromycin achieves sustained high concentration in various ocular tissues including the lid margin. Patients will be treated during 7 days (1 drop twice daily the first day following by one drop once daily for 6 days) following by a period of 2 weeks without treatment. This therapeutic scheme will be repeated two times. Efficacy will be evaluated by change from baseline (Day 0) to Day 63 ± 3 Days of the global ocular discomfort evaluation (VAS).
Interventions
DRUGAzithromycin
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.
DRUGPovidone
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.
Sponsors
Keyrus Biopharma
VEEDA
Laboratoires Thea
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Diagnosis of moderate to severe chronic blepharitis (posterior and/or anterior) in at least one eligible eye
Exclusion criteria
* Monophtalmia * Eyelid dysfunction * Facial paralysis. * Severe dry eye syndrome. * Ocular metaplasia. * Filamentous keratitis * Schirmer test \< 5 mm. * Best far corrected visual acuity \< 1/10.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale (VAS - Ranges 0-100 mm) | Baseline and D63 (D63 minus baseline) | 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) |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 43 |
| 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. | 50 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 4 |
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Unifluid | Azithromycin | Total |
|---|---|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 16.2 | 55.7 years STANDARD_DEVIATION 16.1 | 56.2 years STANDARD_DEVIATION 16.1 |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Male | 17 Participants | 25 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 50 |
| serious Total, serious adverse events | 0 / 43 | 0 / 50 |
Outcome results
Primary
Visual Analogue Scale (VAS - Ranges 0-100 mm)
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)
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Unifluid | Visual Analogue Scale (VAS - Ranges 0-100 mm) | 36.5 units on a scale (from 0 to 100 mm) |
| Azithromycin | Visual Analogue Scale (VAS - Ranges 0-100 mm) | 28.5 units on a scale (from 0 to 100 mm) |
p-value: 0.07295% CI: [-16.3, 0.28]Mixed Models Analysis