A Four Week Study of Azithromycin Ophthalmic Solution, 1% Versus Placebo in Subjects With Dry Eye Disease

Sponsor

Merck Sharp & Dohme LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01014078

Collaborator

(none)

112

Enrollment

Locations

Arms

Duration (Months)

12.4

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study is to compare the safety and efficacy of azithromycin ophthalmic solution, 1% in dry eye subjects over a four week treatment period, using placebo as a comparison.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: Azithromycin Ophthalmic Solution, 1% Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Mar 1, 2010

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Azithromycin Ophthalmic Solution, 1%	Drug: Azithromycin Ophthalmic Solution, 1% 1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)
Placebo Comparator: Placebo	Drug: Placebo 1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)

Arm

Intervention/Treatment

Experimental: Azithromycin Ophthalmic Solution, 1%

Drug: Azithromycin Ophthalmic Solution, 1%

1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)

Placebo Comparator: Placebo

Drug: Placebo

1 drop BID for the first 2 days and then 1 drop once a day for the remainder of the study (29 ± 1 days)

Outcome Measures

Primary Outcome Measures

Tear Break-Up Time (TBUT) [4 weeks]

Secondary Outcome Measures

Corneal Staining [4 weeks]
Tear Volume [4 weeks]
Meibomian gland plugging [4 weeks]
Subject-rated scores of dry eye symptoms [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Have a current diagnosis of dry eye in one or both eyes
Moderate to severe degree of meibomian gland plugging
Have best corrected visual acuity in both eyes of at least +0.7 LogMAR
If female, are non-pregnant or non-lactating

Exclusion Criteria:

Have anterior blepharitis
Have lid structural abnormalities
Have suspected ocular fungal or viral infection
Have had penetrating intraocular surgery in the past 90 days or require penetrating intraocular surgery during the study
Have had ocular surface surgery [e.g., laser-assisted in situ keratomileusis (LASIK), refractive, pterygium] within the past year.
Unable to withhold the use of contact lenses during the study
Have a known hypersensitivity to azithromycin, erythromycin, any other macrolide antibiotic, or any of the other ingredients in the study medication.
Have a history of post vitreous detachment.
Are considered legally blind in 1 eye (LogMAR BCVA= 1.0 or Snellen BCVA= 20/200).
Have permanent conjunctival goblet cell loss or scarring conditions, including cicatricial blepharitis or conjunctivitis.
Have a congenitally absent meibomian gland or lacrimal gland.
Have had cauterization of the punctum or have had punctal plugs (silicone or collagen) inserted or removed within the 90 days prior to the screening.
Have a serious medical condition which would confound study assessments.
Have a concomitant ocular pathology that, in the opinion of the investigator, may confound study assessments.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sall Research Medical Center, Inc.	Artesia	California	United States	90701
2	David Wirta, MD, Inc.	Newport Beach	California	United States	92663
3	North Bay Eye Associates, Inc.	Petaluma	California	United States	94954
4	Kentucky Lions Eye Center	Louisville	Kentucky	United States	40207
5	Tauber Eye Center	Kansas City	Missouri	United States	64111
6	Ophthalmology Associates	Saint Louis	Missouri	United States	63131
7	Abrams Eye Center	Cleveland	Ohio	United States	44115
8	OSU - College of Optometry	Columbus	Ohio	United States	43210
9	Eye Clinics of South Texas	San Antonio	Texas	United States	78209