Trial Outcomes & Findings for Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye (NCT NCT00987727)
NCT ID: NCT00987727
Last Updated: 2011-09-21
Results Overview
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).
COMPLETED
PHASE4
82 participants
Baseline, Day 35
2011-09-21
Participant Flow
Participant milestones
| Measure |
Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
|
Sodium Hyaluronate 0.18% (VISMED® Multi)
sodium hyaluronate 0.18% (VISMED® Multi)
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
41
|
|
Overall Study
COMPLETED
|
36
|
34
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
Baseline characteristics by cohort
| Measure |
Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)
n=41 Participants
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
|
Sodium Hyaluronate 0.18% (VISMED® Multi)
n=41 Participants
sodium hyaluronate 0.18% (VISMED® Multi)
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<65 years
|
22 participants
n=39 Participants
|
29 participants
n=41 Participants
|
51 participants
n=35 Participants
|
|
Age, Customized
>=65 years
|
19 participants
n=39 Participants
|
12 participants
n=41 Participants
|
31 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=39 Participants
|
38 Participants
n=41 Participants
|
74 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline, Day 35Population: 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.
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).
Outcome measures
| Measure |
Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)
n=37 Participants
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
|
Sodium Hyaluronate 0.18% (VISMED® Multi)
n=29 Participants
sodium hyaluronate 0.18% (VISMED® Multi)
|
|---|---|---|
|
Change From Baseline in Global Ocular Staining Score at Day 35
Baseline
|
5.4 Number on a scale (score)
Standard Deviation 1.59
|
5.9 Number on a scale (score)
Standard Deviation 1.47
|
|
Change From Baseline in Global Ocular Staining Score at Day 35
Day 35
|
-1.8 Number on a scale (score)
Standard Deviation 1.95
|
-1.8 Number on a scale (score)
Standard Deviation 2.30
|
SECONDARY outcome
Timeframe: Baseline, Day 35Population: 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.
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.
Outcome measures
| Measure |
Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)
n=37 Participants
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
|
Sodium Hyaluronate 0.18% (VISMED® Multi)
n=27 Participants
sodium hyaluronate 0.18% (VISMED® Multi)
|
|---|---|---|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35
Baseline
|
49.05 Number on a scale (score)
Standard Deviation 17.060
|
51.98 Number on a scale (score)
Standard Deviation 18.164
|
|
Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35
Day 35
|
-13.58 Number on a scale (score)
Standard Deviation 19.047
|
-13.66 Number on a scale (score)
Standard Deviation 16.542
|
Adverse Events
Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)
Sodium Hyaluronate 0.18% (VISMED® Multi)
Serious adverse events
| Measure |
Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)
n=41 participants at risk
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
|
Sodium Hyaluronate 0.18% (VISMED® Multi)
n=38 participants at risk
sodium hyaluronate 0.18% (VISMED® Multi)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
2.4%
1/41
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).
|
0.00%
0/38
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).
|
|
Nervous system disorders
Amyotrophic Lateral Sclerosis
|
0.00%
0/41
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).
|
2.6%
1/38
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).
|
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 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
- Publication restrictions are in place
Restriction type: OTHER