Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis

• Sponsor: Laboratoires Thea (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01089608
• Collaborator: Keyrus Biopharma (Other), VEEDA (Other)
• Enrollment: 93
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Blepharitis	Drug: Azithromycin; Drug: Povidone	Phase 2

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 93 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety Assessment of Azyter® Eye Drops (T1225) in Patients With Blepharitis (Pilot Phase II Clinical Study, Multicentre, Randomised, Double Masked, Comparative, 2 X 40 Patients)
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Unifluid Eye drops in Single Dose Unit	Drug: 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.; Other Names: Unifluid
Experimental: Azithromycin Eye drops Single dose unit	Drug: 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.; Other Names: T1225 1.5% - Azyter -

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	C.H.N.O des XV-XX	Paris		France	75012

Sponsors and Collaborators

• Laboratoires Thea
• Keyrus Biopharma
• VEEDA

Investigators

• Principal Investigator: Christophe BAUDOUIN, Professor,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Laboratoires Thea
• ClinicalTrials.gov Identifier: NCT01089608
• Other Study ID Numbers: LT1225-PII-06/09; 2009-017388-41
• First Posted: Mar 18, 2010
• Last Update Posted: Nov 4, 2014
• Last Verified: Oct 1, 2014

• Keywords provided by Laboratoires Thea: Azyter in patients affected by chronic blepharitis.
• Additional relevant MeSH terms: Blepharitis; Azithromycin; Povidone

Study Results

Participant Flow

Arm/Group Title	Unifluid	Azithromycin
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	43	50
COMPLETED	43	44
NOT COMPLETED	0	6

Baseline Characteristics

Arm/Group Title	Unifluid	Azithromycin	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	43	50	93
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.8 (16.2)	55.7 (16.1)	56.2 (16.1)
Sex: Female, Male (Count of Participants)
Female	26 60.5%	25 50%	51 54.8%
Male	17 39.5%	25 50%	42 45.2%

Outcome Measures

1. Primary Outcome

Title	Visual Analogue Scale (VAS - Ranges 0-100 mm)
Description	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)

Outcome Measure Data

Analysis Population Description

Modified ITT set: all randomised patients with at least one eligible treated eye, for whom any follow-up efficacy data are available.

Arm/Group Title	Unifluid	Azithromycin
Arm/Group Description	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.	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.
Measure Participants	43	50
Least Squares Mean (95% Confidence Interval) [units on a scale (from 0 to 100 mm)]	36.5	28.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Unifluid, Azithromycin
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.072
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-8.01
	Confidence Interval	(2-Sided) 95%; -16.30 to 0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Unifluid		Azithromycin
Arm/Group Description	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.		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.
All Cause Mortality
	Unifluid		Azithromycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Unifluid		Azithromycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Unifluid		Azithromycin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/43 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.