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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01014078
Other study ID # 041-116
Secondary ID P08646
Status Completed
Phase Phase 4
First received November 12, 2009
Last updated September 20, 2011
Start date October 2009
Est. completion date March 2010

Study information

Verified date September 2011
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Sall Research Medical Center, Inc. Artesia California
United States Abrams Eye Center Cleveland Ohio
United States OSU - College of Optometry Columbus Ohio
United States Tauber Eye Center Kansas City Missouri
United States Kentucky Lions Eye Center Louisville Kentucky
United States David Wirta, MD, Inc. Newport Beach California
United States North Bay Eye Associates, Inc. Petaluma California
United States Ophthalmology Associates Saint Louis Missouri
United States Eye Clinics of South Texas San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tear Break-Up Time (TBUT) 4 weeks No
Secondary Corneal Staining 4 weeks No
Secondary Tear Volume 4 weeks No
Secondary Meibomian gland plugging 4 weeks No
Secondary Subject-rated scores of dry eye symptoms 4 weeks No
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