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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Syndromes Conjunctival Diseases Conjunctivitis Corneal Diseases Eye Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

One drop in each eye three to six times daily, as needed

Other names: OPTIVE® MD

sodium hyaluronate 0.18% (VISMED® Multi)

Drug

One drop in each eye three to six times daily, as needed

Other names: VISMED® Multi

Primary outcomes

Change From Baseline in Global Ocular Staining Score at Day 35

Time frame: Baseline, Day 35

Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).

Secondary outcomes

Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35

Time frame: Baseline, Day 35

Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2010
First posted: Oct 1, 2009
Registry last updated: Sep 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed