Status:
COMPLETED
Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
Lead Sponsor:
Allergan
Conditions:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
Eligibility Criteria
Inclusion
- Have been using artificial tears for at least 3 months prior to study inclusion
- Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion
- Having moderate to severe symptoms suggestive of dry eye
Exclusion
- Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study
- Moderate to severe blepharitis
- History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
- History or active signs of ocular allergic disease or ocular herpes within the last year
- History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00987727
Start Date
November 1 2009
End Date
September 1 2010
Last Update
September 21 2011
Active Locations (1)
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1
Paris, France