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

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00987727
• Other study ID #: MAF-AGN-OPH-DE-011
• Status: Completed
• Phase: Phase 4
• First received: September 29, 2009
• Last updated: August 17, 2011
• Start date: November 2009
• Est. completion date: September 2010

Study information

• Verified date: August 2011
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
One drop in each eye three to six times daily, as needed
• sodium hyaluronate 0.18% (VISMED® Multi)
One drop in each eye three to six times daily, as needed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Global Ocular Staining Score at 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).	Baseline, Day 35	No
Secondary	Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at 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.	Baseline, Day 35	No