Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

Allergan

Status and phase

Completed

Phase 4

Conditions

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Treatments

Drug: sodium hyaluronate 0.18% (VISMED® Multi)

Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00987727

MAF-AGN-OPH-DE-011

Details and patient eligibility

About

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.

Enrollment

82 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.