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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00938704

Enrollment

Registered

2009-07-14

Start date

2009-06-30

Completion date

2009-06-30

Last updated

2011-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

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.

Interventions

DRUGcarboxymethylcellulose 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.

DRUGsodium 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2	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

Measure	Time frame	Description
Change From Baseline in Tear Breakup Time (TBUT) at Week 2	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.
Change From Baseline in Corneal Staining at Week 2	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.
Change From Baseline in Conjunctival Staining (Temporal) at Week 2	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.
Change From Baseline in Conjunctival Staining (Nasal) at Week 2	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.

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Carboxymethylcellulose 0.5%, Glycerin 0.9% carboxymethylcellulose 0.5%, glycerin 0.9%	33
Sodium Hyaluronate 0.18% sodium hyaluronate 0.18%	37
Total	70

Baseline characteristics

Characteristic	Carboxymethylcellulose 0.5%, Glycerin 0.9%	Sodium Hyaluronate 0.18%	Total
Age Continuous	54.386 years	48.787 years	51.5865 years
Sex: Female, Male Female	23 Participants	28 Participants	51 Participants
Sex: Female, Male Male	10 Participants	9 Participants	19 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 33	0 / 37
serious Total, serious adverse events	0 / 33	0 / 37

Outcome results

Primary

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.

Time frame: Baseline, Week 2