Back to resultsStudy to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
Primary Purpose
Dry Eye Syndromes
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
carboxymethylcellulose 0.5% +glycerin 0.9%
sodium hyaluronate 0.18%
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
Eligibility Criteria
Inclusion Criteria:
- Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
- Be likely to complete the entire course of study and to comply with appropriate instructions
Exclusion Criteria:
- Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
- Have uncontrolled systemic disease
- Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
- Have anticipated contact lens wear during the study
- Have an active ocular infection
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
carboxymethylcellulose 0.5%, glycerin 0.9%
sodium hyaluronate 0.18%
Outcomes
Primary Outcome Measures
Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2
Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.
Secondary Outcome Measures
Change From Baseline in Tear Breakup Time (TBUT) at Week 2
Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.
Change From Baseline in Corneal Staining at Week 2
Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Change From Baseline in Conjunctival Staining (Temporal) at Week 2
Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Change From Baseline in Conjunctival Staining (Nasal) at Week 2
Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00938704
Brief Title
Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
carboxymethylcellulose 0.5%, glycerin 0.9%
Arm Title
2
Arm Type
Active Comparator
Arm Description
sodium hyaluronate 0.18%
Intervention Type
Drug
Intervention Name(s)
carboxymethylcellulose 0.5% +glycerin 0.9%
Other Intervention Name(s)
Optive™ Sensitive
Intervention Description
To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.
Intervention Type
Drug
Intervention Name(s)
sodium hyaluronate 0.18%
Other Intervention Name(s)
Vismed®
Intervention Description
To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.
Primary Outcome Measure Information:
Title
Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2
Description
Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.
Time Frame
Baseline, Week 2
Secondary Outcome Measure Information:
Title
Change From Baseline in Tear Breakup Time (TBUT) at Week 2
Description
Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.
Time Frame
Baseline, Week 2
Title
Change From Baseline in Corneal Staining at Week 2
Description
Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Time Frame
Baseline, Week 2
Title
Change From Baseline in Conjunctival Staining (Temporal) at Week 2
Description
Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Time Frame
Baseline, Week 2
Title
Change From Baseline in Conjunctival Staining (Nasal) at Week 2
Description
Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Time Frame
Baseline, Week 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
Be likely to complete the entire course of study and to comply with appropriate instructions
Exclusion Criteria:
Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
Have uncontrolled systemic disease
Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
Have anticipated contact lens wear during the study
Have an active ocular infection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Ulm
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
We'll reach out to this number within 24 hrs