A Phase 4 interventional study of carboxymethylcellulose 0.5% +glycerin 0.9% and sodium hyaluronate 0.18% in Dry Eye Syndromes, sponsored by Allergan. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-31.
Sponsored by Allergan · Phase 4, Interventional, and Treatment
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.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 71 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
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Exclusion Criteria:
carboxymethylcellulose 0.5%, glycerin 0.9%
Drug: carboxymethylcellulose 0.5% +glycerin 0.9%
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.
Also known as: Optive™ Sensitive
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.
Also known as: Vismed®
Change From Baseline in Ocular Surface Disease Index (OSDI) at 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.
Time frame: Baseline, Week 2
Change From Baseline in Tear Breakup Time (TBUT) at 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.
Time frame: Baseline, Week 2
Change From Baseline in Corneal Staining at 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.
Time frame: Baseline, Week 2
Change From Baseline in Conjunctival Staining (Temporal) at 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.
Time frame: Baseline, Week 2
Change From Baseline in Conjunctival Staining (Nasal) at 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.
Time frame: Baseline, Week 2
| Milestone | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Sodium Hyaluronate 0.18% |
|---|---|---|
| Started | 33 | 37 |
| Completed | 33 | 37 |
| Not completed | 0 | 0 |
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.
| Scores on a Scale | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Sodium Hyaluronate 0.18% |
|---|---|---|
| Baseline | 56.06 ± 13.43 | 54.292 ± 13.100 |
| Week 2 | -27.048 ± 17.87 | -28.303 ± 21.821 |
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.
| Seconds | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Sodium Hyaluronate 0.18% |
|---|---|---|
| Baseline | 6.501 ± 1.73 | 5.914 ± 1.646 |
| Week 2 | 2.919 ± 2.388 | 2.538 ± 2.923 |
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.
| Scores on a Scale | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Sodium Hyaluronate 0.18% |
|---|---|---|
| Baseline | 1.818 ± 0.779 | 1.608 ± 0.936 |
| Week 2 | -1.288 ± 0.718 | -1.23 ± 1.090 |
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.
| Scores on a Scale | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Sodium Hyaluronate 0.18% |
|---|---|---|
| Baseline | 1.818 ± 0.950 | 1.919 ± 1.010 |
| Week 2 | -1.152 ± 0.972 | -1.216 ± 1.084 |
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.
| Scores on a Scale | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Sodium Hyaluronate 0.18% |
|---|---|---|
| Baseline | 1.758 ± 0.902 | 2.000 ± 0.913 |
| Week 2 | -1.061 ± 0.899 | -1.459 ± 1.043 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carboxymethylcellulose 0.5%, Glycerin 0.9% | — | 0/33 (0%) | 0/33 (0%) |
| Sodium Hyaluronate 0.18% | — | 0/37 (0%) | 0/37 (0%) |
| Age Continuous(years) | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Sodium Hyaluronate 0.18% | Total |
|---|---|---|---|
| Mean | 54.386 (20.277 to 87.485) | 48.787 (18.942 to 84.482) | 51.5865 (18.942 to 87.485) |
| Sex: Female, Male(Participants) | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Sodium Hyaluronate 0.18% | Total |
|---|---|---|---|
| Female | 23 | 28 | 51 |
| Male | 10 | 9 | 19 |
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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