Trial Outcomes & Findings for Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms (NCT NCT00938704)
NCT ID: NCT00938704
Last Updated: 2011-10-31
Results Overview
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.
COMPLETED
PHASE4
71 participants
Baseline, Week 2
2011-10-31
Participant Flow
Participant milestones
| Measure |
Carboxymethylcellulose 0.5%, Glycerin 0.9%
carboxymethylcellulose 0.5%, glycerin 0.9%
|
Sodium Hyaluronate 0.18%
sodium hyaluronate 0.18%
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
37
|
|
Overall Study
COMPLETED
|
33
|
37
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
Baseline characteristics by cohort
| Measure |
Carboxymethylcellulose 0.5%, Glycerin 0.9%
n=33 Participants
carboxymethylcellulose 0.5%, glycerin 0.9%
|
Sodium Hyaluronate 0.18%
n=37 Participants
sodium hyaluronate 0.18%
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
54.386 years
n=5 Participants
|
48.787 years
n=7 Participants
|
51.5865 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2Population: Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).
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.
Outcome measures
| Measure |
Carboxymethylcellulose 0.5%, Glycerin 0.9%
n=33 Participants
carboxymethylcellulose 0.5%, glycerin 0.9%
|
Sodium Hyaluronate 0.18%
n=37 Participants
sodium hyaluronate 0.18%
|
|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2
Baseline
|
56.06 Scores on a Scale
Standard Deviation 13.43
|
54.292 Scores on a Scale
Standard Deviation 13.100
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2
Week 2
|
-27.048 Scores on a Scale
Standard Deviation 17.87
|
-28.303 Scores on a Scale
Standard Deviation 21.821
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).
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.
Outcome measures
| Measure |
Carboxymethylcellulose 0.5%, Glycerin 0.9%
n=33 Participants
carboxymethylcellulose 0.5%, glycerin 0.9%
|
Sodium Hyaluronate 0.18%
n=37 Participants
sodium hyaluronate 0.18%
|
|---|---|---|
|
Change From Baseline in Tear Breakup Time (TBUT) at Week 2
Baseline
|
6.501 Seconds
Standard Deviation 1.73
|
5.914 Seconds
Standard Deviation 1.646
|
|
Change From Baseline in Tear Breakup Time (TBUT) at Week 2
Week 2
|
2.919 Seconds
Standard Deviation 2.388
|
2.538 Seconds
Standard Deviation 2.923
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).
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.
Outcome measures
| Measure |
Carboxymethylcellulose 0.5%, Glycerin 0.9%
n=33 Participants
carboxymethylcellulose 0.5%, glycerin 0.9%
|
Sodium Hyaluronate 0.18%
n=37 Participants
sodium hyaluronate 0.18%
|
|---|---|---|
|
Change From Baseline in Corneal Staining at Week 2
Baseline
|
1.818 Scores on a Scale
Standard Deviation 0.779
|
1.608 Scores on a Scale
Standard Deviation 0.936
|
|
Change From Baseline in Corneal Staining at Week 2
Week 2
|
-1.288 Scores on a Scale
Standard Deviation 0.718
|
-1.23 Scores on a Scale
Standard Deviation 1.090
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).
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.
Outcome measures
| Measure |
Carboxymethylcellulose 0.5%, Glycerin 0.9%
n=33 Participants
carboxymethylcellulose 0.5%, glycerin 0.9%
|
Sodium Hyaluronate 0.18%
n=37 Participants
sodium hyaluronate 0.18%
|
|---|---|---|
|
Change From Baseline in Conjunctival Staining (Temporal) at Week 2
Week 2
|
-1.152 Scores on a Scale
Standard Deviation 0.972
|
-1.216 Scores on a Scale
Standard Deviation 1.084
|
|
Change From Baseline in Conjunctival Staining (Temporal) at Week 2
Baseline
|
1.818 Scores on a Scale
Standard Deviation 0.950
|
1.919 Scores on a Scale
Standard Deviation 1.010
|
SECONDARY outcome
Timeframe: Baseline, Week 2Population: Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized).
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.
Outcome measures
| Measure |
Carboxymethylcellulose 0.5%, Glycerin 0.9%
n=33 Participants
carboxymethylcellulose 0.5%, glycerin 0.9%
|
Sodium Hyaluronate 0.18%
n=37 Participants
sodium hyaluronate 0.18%
|
|---|---|---|
|
Change From Baseline in Conjunctival Staining (Nasal) at Week 2
Baseline
|
1.758 Scores on a Scale
Standard Deviation 0.902
|
2.000 Scores on a Scale
Standard Deviation 0.913
|
|
Change From Baseline in Conjunctival Staining (Nasal) at Week 2
Week 2
|
-1.061 Scores on a Scale
Standard Deviation 0.899
|
-1.459 Scores on a Scale
Standard Deviation 1.043
|
Adverse Events
Carboxymethylcellulose 0.5%, Glycerin 0.9%
Sodium Hyaluronate 0.18%
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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 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.
- Publication restrictions are in place
Restriction type: OTHER