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

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ClinicalTrials.gov Identifier: NCT00938704
Recruitment Status : Completed
First Posted : July 14, 2009
Results First Posted : October 31, 2011
Last Update Posted : October 31, 2011
Sponsor:
Information provided by (Responsible Party):
Allergan

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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: carboxymethylcellulose 0.5% +glycerin 0.9% Drug: sodium hyaluronate 0.18% Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2009
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
carboxymethylcellulose 0.5%, glycerin 0.9%
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
Active Comparator: 2
sodium hyaluronate 0.18%
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®



Primary Outcome Measures :
  1. Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 [ Time Frame: Baseline, 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 :
  1. Change From Baseline in Tear Breakup Time (TBUT) at Week 2 [ Time Frame: Baseline, 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.

  2. Change From Baseline in Corneal Staining at Week 2 [ Time Frame: Baseline, 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.

  3. Change From Baseline in Conjunctival Staining (Temporal) at Week 2 [ Time Frame: Baseline, 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.

  4. Change From Baseline in Conjunctival Staining (Nasal) at Week 2 [ Time Frame: Baseline, 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938704


Locations
Germany
Ulm, Germany
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00938704     History of Changes
Other Study ID Numbers: MA-OPT-09-002
First Posted: July 14, 2009    Key Record Dates
Results First Posted: October 31, 2011
Last Update Posted: October 31, 2011
Last Verified: September 2011

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Glycerol
Hyaluronic Acid
Carboxymethylcellulose Sodium
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors
Viscosupplements
Laxatives
Gastrointestinal Agents