Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00514852
• Collaborator: (none)
• Enrollment: 316
• Location: 1
• Arms: 2
• Duration (Months): 3
• Patients Per Site Per Month: 104.5

Study Details

Study Description

Brief Summary

The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: Carboxymethylcellulose and Glycerin based artificial tear; Drug: Carboxymethylcellulose	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 316 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Carboxymethylcellulose and Glycerin based artificial tear	Drug: Carboxymethylcellulose and Glycerin based artificial tear; 1 to 2 drops into each eye as needed but at least twice daily
Active Comparator: 2 Carboxymethylcellulose	Drug: Carboxymethylcellulose; 1 to 2 drops into each eye as needed but at least twice daily; Other Names: Refresh Plus

Outcome Measures

Primary Outcome Measures

1. Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score [Change from baseline at Day 30]

   Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)

Secondary Outcome Measures

1. Change From Baseline at Day 30 in Schirmer Test, With Anesthesia [Change from baseline at Day 30]

   Schirmer Test measures the rate of the secretion of tears

2. Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein [Change from baseline at Day 30]

   Measures the stability of tear film. The average of 3 measures.

3. Patient Acceptability Score (Dryness) at Day 30 [Day 30]

   Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).

4. Patient Acceptability Score (Vision) at Day 30 [Day 30]

   Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better).

5. Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein [Change from baseline at Day 30]

   Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining)

6. Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein [Change from baseline at Day 30]

   Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining)

7. Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score [Change from baseline at Day 30]

   Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Mild, moderate or Severe Symptoms of Dry Eye

Exclusion Criteria:

• Uncontrolled systemic disease

• Use of systemic medications affecting dry eye

• Pregnancy or planning a pregnancy

• Contact lens wear

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		San Diego	California	United States

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00514852
• Other Study ID Numbers: AG9818-002
• First Posted: Aug 10, 2007
• Last Update Posted: Dec 15, 2009
• Last Verified: Nov 1, 2009

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Carboxymethylcellulose Sodium; Lubricant Eye Drops; Glycerol

Study Results

Participant Flow

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Period Title: Overall Study
STARTED	157	159
COMPLETED	152	154
NOT COMPLETED	5	5

Baseline Characteristics

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear	Total
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily	Total of all reporting groups
Overall Participants	157	159	316
Age, Customized (participants) [Number]
<40 years	18 11.5%	15 9.4%	33 10.4%
>=40 years	139 88.5%	144 90.6%	283 89.6%
Sex: Female, Male (Count of Participants)
Female	120 76.4%	125 78.6%	245 77.5%
Male	37 23.6%	34 21.4%	71 22.5%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
Description	Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)
Time Frame	Change from baseline at Day 30

Outcome Measure Data

Analysis Population Description

Intent to Treat Population (Modified)

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Measure Participants	147	154
Day 1 (Baseline)	44 (18.1)	45.2 (18.3)
Day 7	-12.6 (14.9)	-13.6 (17.8)
Day 30	-16.3 (16.4)	-16.6 (20.3)

2. Secondary Outcome

Title	Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Description	Schirmer Test measures the rate of the secretion of tears
Time Frame	Change from baseline at Day 30

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Measure Participants	157	159
Day 1 (Baseline)	9.2 (7.2)	8.6 (6.8)
Day 7	1.2 (5.1)	1.2 (5.6)
Day 30	1.7 (6.9)	1.8 (7.3)

3. Secondary Outcome

Title	Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Description	Measures the stability of tear film. The average of 3 measures.
Time Frame	Change from baseline at Day 30

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Measure Participants	157	159
Day 1 (Baseline)	4.3 (2.1)	4.3 (2.0)
Day 7	0.9 (2.3)	0.9 (2.1)
Day 30	1.1 (2.7)	0.9 (2.4)

4. Secondary Outcome

Title	Patient Acceptability Score (Dryness) at Day 30
Description	Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Measure Participants	157	159
Day 1 (Baseline)	47.4 (22.8)	44.6 (20.5)
Day 7	60.7 (21.1)	57.7 (22.5)
Day 30	63.3 (22.7)	63.8 (22.8)

5. Secondary Outcome

Title	Patient Acceptability Score (Vision) at Day 30
Description	Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better).
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

Intent to treat population

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Measure Participants	157	159
Day 1 (Baseline)	56.8 (22.4)	54.2 (21.6)
Day 7	65.3 (17.8)	62.6 (19.6)
Day 30	65.4 (20.1)	66.4 (19.4)

6. Post-Hoc Outcome

Title	Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30
Description	Vision subscale of the Ocular Surface Disease Index Questionnaire© is measured on 6 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity)
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

Intent to Treat Population (Modified)

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Measure Participants	147	154
Day 1 (Baseline)	37.6 (21.5)	41.6 (21.6)
Day 7	24.8 (20.0)	26.9 (20.2)
Day 30	22.8 (20.4)	25.6 (22.4)

7. Post-Hoc Outcome

Title	Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30
Description	Central staining score is based on modified Oxford Scheme measured on a scale of 0-5 (0= no staining, 5= most severe staining)
Time Frame	Day 30

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Measure Participants	157	159
Day 1 (Baseline)	0.7 (0.8)	0.8 (0.8)
Day 7	0.5 (0.7)	0.5 (0.7)
Day 30	0.4 (0.6)	0.4 (0.7)

8. Secondary Outcome

Title	Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
Description	Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining)
Time Frame	Change from baseline at Day 30

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Measure Participants	157	159
Day 1 (Baseline)	4.0 (3.3)	4.4 (3.4)
Day 7	-1.2 (2.3)	-0.9 (2.4)
Day 30	-1.3 (2.4)	-1.5 (2.5)

9. Secondary Outcome

Title	Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
Description	Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining)
Time Frame	Change from baseline at Day 30

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Measure Participants	157	159
Day 1 (Baseline)	4.9 (4.4)	5.1 (5.0)
Day 7	-1.1 (3.1)	-1.0 (3.2)
Day 30	-1.7 (3.3)	-1.5 (2.8)

10. Secondary Outcome

Title	Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score
Description	Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)
Time Frame	Change from baseline at Day 30

Outcome Measure Data

Analysis Population Description

Intent to Treat Population

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear	Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily	1 to 2 drops into each eye as needed but at least twice daily
Measure Participants	157	159
Day 1 (Baseline)	2.8 (0.7)	2.8 (0.8)
Day 7	-0.5 (0.8)	-0.5 (0.8)
Day 30	-0.7 (1.0)	-0.7 (0.9)

Adverse Events

Arm/Group Title	Carboxymethylcellulose and Glycerin Based Artificial Tear		Carboxymethylcellulose Based Artificial Tear
Arm/Group Description	1 to 2 drops into each eye as needed but at least twice daily		1 to 2 drops into each eye as needed but at least twice daily
All Cause Mortality
	Carboxymethylcellulose and Glycerin Based Artificial Tear		Carboxymethylcellulose Based Artificial Tear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Carboxymethylcellulose and Glycerin Based Artificial Tear		Carboxymethylcellulose Based Artificial Tear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/157 (0.6%)		1/159 (0.6%)
Nervous system disorders
Transient Ischaemic Attack	1/157 (0.6%)		0/159 (0%)
Reproductive system and breast disorders
Menorrhagia	0/157 (0%)		1/159 (0.6%)
Other (Not Including Serious) Adverse Events
	Carboxymethylcellulose and Glycerin Based Artificial Tear		Carboxymethylcellulose Based Artificial Tear
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/157 (0%)		0/159 (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 more than 60 days but 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.