Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT00938704
First received: July 10, 2009
Last updated: September 22, 2011
Last verified: September 2011

July 10, 2009
September 22, 2011
June 2009
June 2009   (final data collection date for primary outcome measure)
Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
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.
Ocular Surface Disease Index [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00938704 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Tear Breakup Time (TBUT) at Week 2 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, Week 2 ] [ Designated as safety issue: No ]
    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.
  • Tear Breakup Time [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Corneal Staining [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Conjunctival Staining [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Patient Questionnaires [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dry Eye Syndromes
  • Drug: carboxymethylcellulose 0.5% +glycerin 0.9%
    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.
    Other Name: Optive™ Sensitive
  • Drug: sodium hyaluronate 0.18%
    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.
    Other Name: Vismed®
  • Active Comparator: 1
    carboxymethylcellulose 0.5%, glycerin 0.9%
    Intervention: Drug: carboxymethylcellulose 0.5% +glycerin 0.9%
  • Active Comparator: 2
    sodium hyaluronate 0.18%
    Intervention: Drug: sodium hyaluronate 0.18%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00938704
MA-OPT-09-002
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP