NCT01014078

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 12, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 26, 2011

Status Verified

September 1, 2011

Enrollment Period

5 months

First QC Date

November 12, 2009

Last Update Submit

September 20, 2011

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (1)

  • Tear Break-Up Time (TBUT)

    4 weeks

Secondary Outcomes (4)

  • Corneal Staining

    4 weeks

  • Tear Volume

    4 weeks

  • Meibomian gland plugging

    4 weeks

  • Subject-rated scores of dry eye symptoms

    4 weeks

Study Arms (2)

Azithromycin Ophthalmic Solution, 1%

EXPERIMENTAL
Drug: Azithromycin Ophthalmic Solution, 1%

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Azithromycin Ophthalmic Solution, 1%DRUG

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

Azithromycin Ophthalmic Solution, 1%
PlaceboDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Sall Research Medical Center, Inc.

Artesia, California, 90701, United States

Location

David Wirta, MD, Inc.

Newport Beach, California, 92663, United States

Location

North Bay Eye Associates, Inc.

Petaluma, California, 94954, United States

Location

Kentucky Lions Eye Center

Louisville, Kentucky, 40207, United States

Location

Tauber Eye Center

Kansas City, Missouri, 64111, United States

Location

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Abrams Eye Center

Cleveland, Ohio, 44115, United States

Location

OSU - College of Optometry

Columbus, Ohio, 43210, United States

Location

Eye Clinics of South Texas

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Reza Haque, MD, PhD

    Medical Monitor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 12, 2009

First Posted

November 16, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 26, 2011

Record last verified: 2011-09

Locations

US(9)