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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00987727
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes; Keratoconjunctivitis Sicca	Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD); Drug: sodium hyaluronate 0.18% (VISMED® Multi)	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
• Study Start Date: Nov 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Sep 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)	Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD); One drop in each eye three to six times daily, as needed; Other Names: OPTIVE® MD
Active Comparator: 2 sodium hyaluronate 0.18% (VISMED® Multi)	Drug: sodium hyaluronate 0.18% (VISMED® Multi); One drop in each eye three to six times daily, as needed; Other Names: VISMED® Multi

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Global Ocular Staining Score at Day 35 [Baseline, Day 35]

   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).

Secondary Outcome Measures

1. Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 [Baseline, Day 35]

   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.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Have been using artificial tears for at least 3 months prior to study inclusion

• Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion

• Having moderate to severe symptoms suggestive of dry eye

Exclusion Criteria:

• Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study

• Moderate to severe blepharitis

• History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months

• History or active signs of ocular allergic disease or ocular herpes within the last year

• History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Paris		France

Sponsors and Collaborators

• Allergan

Investigators

• Study Director: Medical Director, Allergan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00987727
• Other Study ID Numbers: MAF-AGN-OPH-DE-011
• First Posted: Oct 1, 2009
• Last Update Posted: Sep 21, 2011
• Last Verified: Aug 1, 2011

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

Study Results

Participant Flow

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 Participants	41	41	82
Age, Customized (participants) [Number]
<65 years	22 53.7%	29 70.7%	51 62.2%
>=65 years	19 46.3%	12 29.3%	31 37.8%
Sex: Female, Male (Count of 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)
Measure Participants	37	29
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)
Measure Participants	37	27
Baseline	49.05 (17.060)	51.98 (18.164)
Day 35	-13.58 (19.047)	-13.66 (16.542)

Adverse Events

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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)		Sodium Hyaluronate 0.18% (VISMED® Multi)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/41 (2.4%)		1/38 (2.6%)
Injury, poisoning and procedural complications
Upper Limb Fracture	1/41 (2.4%)		0/38 (0%)
Nervous system disorders
Amyotrophic Lateral Sclerosis	0/41 (0%)		1/38 (2.6%)
Other (Not Including Serious) Adverse Events
	Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)		Sodium Hyaluronate 0.18% (VISMED® Multi)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/38 (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 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