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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) Sodium Hyaluronate 0.18% (VISMED® Multi)
Hide 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
Arm/Group Title Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD) Sodium Hyaluronate 0.18% (VISMED® Multi) Total
Hide 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
Hide 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%
1.Primary Outcome
Title Change From Baseline in Global Ocular Staining Score at Day 35
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
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)
Hide 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   --/--   --/-- 
Hide 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)
Hide 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%) 
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
Layout table for Results Point of Contact information
Name/Title: Vice President Medical Affairs
Organization: Allergan, Inc
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
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