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

Purpose

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	Intervention	Phase
Dry Eye Syndromes	Drug: carboxymethylcellulose 0.5% +glycerin 0.9% Drug: sodium hyaluronate 0.18%	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: keratitis-ichthyosis-deafness syndrome

Drug Information available for: Glycerin Carboxymethylcellulose sodium Hyaluronic Acid Hyaluronate Sodium Croscarmellose sodium

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Enrollment:	71
Study Start Date:	June 2009
Study Completion Date:	June 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938704

Locations

Germany

Ulm, Germany

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT00938704 History of Changes
Other Study ID Numbers:	MA-OPT-09-002
Study First Received:	July 10, 2009
Results First Received:	September 22, 2011
Last Updated:	September 22, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Dry Eye Syndromes
Keratoconjunctivitis Sicca
Signs and Symptoms
Lacrimal Apparatus Diseases
Eye Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium

Glycerol
Hyaluronic Acid
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on May 23, 2013