Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

• ClinicalTrials.gov Identifier: NCT00987727
• Recruitment Status: Completed
• First Posted: October 1, 2009
• Results First Posted: September 21, 2011
• Last Update Posted: September 21, 2011
• Sponsor: Allergan
• Information provided by: Allergan

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Interventions: Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD); Drug: sodium hyaluronate 0.18% (VISMED® Multi)
• Enrollment: 82

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)	Sodium Hyaluronate 0.18% (VISMED® Multi)
Arm/Group Description	carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)	sodium hyaluronate 0.18% (VISMED® Multi)
Period Title: Overall Study
Started	41	41
Completed	36	34
Not Completed	5	7

Baseline Characteristics

Arm/Group Title		Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)	Sodium Hyaluronate 0.18% (VISMED® Multi)	Total
Arm/Group Description		carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)	sodium hyaluronate 0.18% (VISMED® Multi)	Total of all reporting groups
Overall Number of Baseline Participants		41	41	82
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	41 participants	41 participants	82 participants
<65 years		22	29	51
>=65 years		19	12	31
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	41 participants	41 participants	82 participants
	Female	36 87.8%	38 92.7%	74 90.2%
	Male	5 12.2%	3 7.3%	8 9.8%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Global Ocular Staining Score at Day 35
Description	Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).
Time Frame	Baseline, Day 35

Outcome Measure Data

Analysis Population Description

Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.

Arm/Group Title	Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)	Sodium Hyaluronate 0.18% (VISMED® Multi)
Arm/Group Description:	carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)	sodium hyaluronate 0.18% (VISMED® Multi)
Overall Number of Participants Analyzed	37	29
Mean (Standard Deviation); Unit of Measure: Number on a scale (score)
Baseline	5.4 (1.59)	5.9 (1.47)
Day 35	-1.8 (1.95)	-1.8 (2.30)

2. Secondary Outcome

Title	Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35
Description	Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms.
Time Frame	Baseline, Day 35

Outcome Measure Data

Analysis Population Description

Per Protocol: All subjects who were randomised, who received at least one dose of the study product, had at least one follow-up visit and who did not have significant protocol violations and who completed the assessment of this outcome measure at Day 35.

Arm/Group Title	Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)	Sodium Hyaluronate 0.18% (VISMED® Multi)
Arm/Group Description:	carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)	sodium hyaluronate 0.18% (VISMED® Multi)
Overall Number of Participants Analyzed	37	27
Mean (Standard Deviation); Unit of Measure: Number on a scale (score)
Baseline	49.05 (17.060)	51.98 (18.164)
Day 35	-13.58 (19.047)	-13.66 (16.542)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	The safety population included all subjects who were randomized and treated with at least one dose of the study product. (Note: 3 randomized subjects in the VISMED® Multi group did not receive a dose and were not included in the safety population).
Arm/Group Title	Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)	Sodium Hyaluronate 0.18% (VISMED® Multi)
Arm/Group Description	carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)	sodium hyaluronate 0.18% (VISMED® Multi)
All-Cause Mortality
	Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)	Sodium Hyaluronate 0.18% (VISMED® Multi)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)	Sodium Hyaluronate 0.18% (VISMED® Multi)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	1/41 (2.44%)	1/38 (2.63%)
Injury, poisoning and procedural complications
Upper Limb Fracture † 1	1/41 (2.44%)	0/38 (0.00%)
Nervous system disorders
Amyotrophic Lateral Sclerosis † 1	0/41 (0.00%)	1/38 (2.63%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA (12.1)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)	Sodium Hyaluronate 0.18% (VISMED® Multi)
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/41 (0.00%)	0/38 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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 at least 30 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo

Results Point of Contact

• Name/Title: Vice President Medical Affairs
• Organization: Allergan, Inc
• Phone: 714-246-4500
• EMail: clinicaltrials@allergan.com

• Responsible Party: Vice President Medical Affairs, Allergan, Inc.
• ClinicalTrials.gov Identifier: NCT00987727
• Other Study ID Numbers: MAF-AGN-OPH-DE-011
• First Submitted: September 29, 2009
• First Posted: October 1, 2009
• Results First Submitted: August 17, 2011
• Results First Posted: September 21, 2011
• Last Update Posted: September 21, 2011