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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00938704
• Collaborator: (none)
• Enrollment: 71
• Location: 1
• Arms: 2

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Jun 1, 2009
• Actual Study Completion Date: Jun 1, 2009

Arms and Interventions

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 Names: 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 Names: Vismed®

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Ulm		Germany

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT00938704
• Other Study ID Numbers: MA-OPT-09-002
• First Posted: Jul 14, 2009
• Last Update Posted: Oct 31, 2011
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Carboxymethylcellulose Sodium; Hyaluronic Acid; Glycerol

Study Results

Participant Flow

Arm/Group Title	Carboxymethylcellulose 0.5%, Glycerin 0.9%	Sodium Hyaluronate 0.18%
Arm/Group Description	carboxymethylcellulose 0.5%, glycerin 0.9%	sodium hyaluronate 0.18%
Period Title: Overall Study
STARTED	33	37
COMPLETED	33	37
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Carboxymethylcellulose 0.5%, Glycerin 0.9%	Sodium Hyaluronate 0.18%	Total
Arm/Group Description	carboxymethylcellulose 0.5%, glycerin 0.9%	sodium hyaluronate 0.18%	Total of all reporting groups
Overall Participants	33	37	70
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	54.386	48.787	51.5865
Sex: Female, Male (Count of Participants)
Female	23 69.7%	28 75.7%	51 72.9%
Male	10 30.3%	9 24.3%	19 27.1%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2
Description	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

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).

Arm/Group Title	Carboxymethylcellulose 0.5%, Glycerin 0.9%	Sodium Hyaluronate 0.18%
Arm/Group Description	carboxymethylcellulose 0.5%, glycerin 0.9%	sodium hyaluronate 0.18%
Measure Participants	33	37
Baseline	56.06 (13.43)	54.292 (13.100)
Week 2	-27.048 (17.87)	-28.303 (21.821)

2. Secondary Outcome

Title	Change From Baseline in Tear Breakup Time (TBUT) at Week 2
Description	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.
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).

Arm/Group Title	Carboxymethylcellulose 0.5%, Glycerin 0.9%	Sodium Hyaluronate 0.18%
Arm/Group Description	carboxymethylcellulose 0.5%, glycerin 0.9%	sodium hyaluronate 0.18%
Measure Participants	33	37
Baseline	6.501 (1.73)	5.914 (1.646)
Week 2	2.919 (2.388)	2.538 (2.923)

3. Secondary Outcome

Title	Change From Baseline in Corneal Staining at Week 2
Description	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.
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).

Arm/Group Title	Carboxymethylcellulose 0.5%, Glycerin 0.9%	Sodium Hyaluronate 0.18%
Arm/Group Description	carboxymethylcellulose 0.5%, glycerin 0.9%	sodium hyaluronate 0.18%
Measure Participants	33	37
Baseline	1.818 (0.779)	1.608 (0.936)
Week 2	-1.288 (0.718)	-1.23 (1.090)

4. Secondary Outcome

Title	Change From Baseline in Conjunctival Staining (Temporal) at Week 2
Description	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.
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).

Arm/Group Title	Carboxymethylcellulose 0.5%, Glycerin 0.9%	Sodium Hyaluronate 0.18%
Arm/Group Description	carboxymethylcellulose 0.5%, glycerin 0.9%	sodium hyaluronate 0.18%
Measure Participants	33	37
Baseline	1.818 (0.950)	1.919 (1.010)
Week 2	-1.152 (0.972)	-1.216 (1.084)

5. Secondary Outcome

Title	Change From Baseline in Conjunctival Staining (Nasal) at Week 2
Description	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.
Time Frame	Baseline, Week 2

Outcome Measure Data

Analysis Population Description

Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).

Arm/Group Title	Carboxymethylcellulose 0.5%, Glycerin 0.9%	Sodium Hyaluronate 0.18%
Arm/Group Description	carboxymethylcellulose 0.5%, glycerin 0.9%	sodium hyaluronate 0.18%
Measure Participants	33	37
Baseline	1.758 (0.902)	2.000 (0.913)
Week 2	-1.061 (0.899)	-1.459 (1.043)

Adverse Events

Arm/Group Title	Carboxymethylcellulose 0.5%, Glycerin 0.9%		Sodium Hyaluronate 0.18%
Arm/Group Description	carboxymethylcellulose 0.5%, glycerin 0.9%		sodium hyaluronate 0.18%
All Cause Mortality
	Carboxymethylcellulose 0.5%, Glycerin 0.9%		Sodium Hyaluronate 0.18%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Carboxymethylcellulose 0.5%, Glycerin 0.9%		Sodium Hyaluronate 0.18%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/37 (0%)
Other (Not Including Serious) Adverse Events
	Carboxymethylcellulose 0.5%, Glycerin 0.9%		Sodium Hyaluronate 0.18%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/37 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.