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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00987727
Other study ID # MAF-AGN-OPH-DE-011
Secondary ID
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


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
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