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

August 17, 2011 updated by: Allergan
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
One drop in each eye three to six times daily, as needed
Other Names:
  • OPTIVE® MD
Active Comparator: 2
sodium hyaluronate 0.18% (VISMED® Multi)
Drug: sodium hyaluronate 0.18% (VISMED® Multi)
One drop in each eye three to six times daily, as needed
Other Names:
  • VISMED® Multi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, Day 35

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 30, 2009

First Posted (Estimate)

October 1, 2009

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

August 17, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAF-AGN-OPH-DE-011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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