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Completed

NCT Number: NCT00938704

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

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.

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ulm, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboxymethylcellulose 0.5% +glycerin 0.9%

Drug

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 names: Optive™ Sensitive

sodium hyaluronate 0.18%

Drug

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 names: Vismed®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jul 14, 2009
Registry last updated
Oct 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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