Trial Outcomes & Findings for Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension (NCT NCT00947661)
NCT ID: NCT00947661
Last Updated: 2021-03-09
Results Overview
95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
578 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-03-09
Participant Flow
Participant milestones
| Measure |
SPARC0912
SPARC0912 administered once daily for 12 weeks
|
Reference0912
Reference0912 administered once daily for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
289
|
289
|
|
Overall Study
COMPLETED
|
276
|
274
|
|
Overall Study
NOT COMPLETED
|
13
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
SPARC0912
n=289 Participants
SPARC0912 administered once daily for 12 weeks
|
Reference0912
n=289 Participants
Reference0912 administered once daily for 12 weeks
|
Total
n=578 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 9.59 • n=5 Participants
|
63.8 years
STANDARD_DEVIATION 11.08 • n=7 Participants
|
63.4 years
STANDARD_DEVIATION 10.36 • n=5 Participants
|
|
Sex: Female, Male
Female
|
186 Participants
n=5 Participants
|
188 Participants
n=7 Participants
|
374 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent to treat population without LOCF
95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12)
Outcome measures
| Measure |
SPARC0912
n=275 Participants
The change from baseline in intraocular pressure was calculated. A positive change from baseline suggested a reduction from baseline in intraocular pressure. Change from baseline was analyzed using an analysis of covariance methodology, a two-sided 95% CI for the difference between treatment groups in estimated mean change from baseline (i.e., LS means derived from the ANCOVA model) was computed for each time point at each visit (a total of 12 time points at 4 visits i.e. 3 time points at each visit).
|
Reference0912
n=276 Participants
|
|---|---|---|
|
Change in Intraocular Pressure From Baseline to Week 12
|
6.12 mm Hg
Standard Error 0.23
|
6.91 mm Hg
Standard Error 0.23
|
Adverse Events
SPARC0912
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Reference0912
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SPARC0912
n=289 participants at risk
SPARC's formulation administered once daily for 12 weeks
|
Reference0912
n=289 participants at risk
Reference formulation administered once daily for 12 weeks
|
|---|---|---|
|
Eye disorders
Macular edema
|
0.00%
0/289
|
0.35%
1/289 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/289
|
0.35%
1/289 • Number of events 1
|
|
General disorders
Colitis
|
0.00%
0/289
|
0.35%
1/289 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/289
|
0.35%
1/289 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/289
|
0.35%
1/289 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.35%
1/289 • Number of events 1
|
0.00%
0/289
|
|
General disorders
Chest pain
|
0.35%
1/289 • Number of events 1
|
0.00%
0/289
|
|
Investigations
Elevated blood pressure
|
0.35%
1/289 • Number of events 1
|
0.00%
0/289
|
Other adverse events
| Measure |
SPARC0912
n=289 participants at risk
SPARC's formulation administered once daily for 12 weeks
|
Reference0912
n=289 participants at risk
Reference formulation administered once daily for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
abdominal pain, colitis
|
0.00%
0/289
|
0.69%
2/289
|
|
General disorders
Chest pain
|
0.35%
1/289
|
0.00%
0/289
|
|
Investigations
Blood pressure increased
|
0.35%
1/289
|
0.00%
0/289
|
|
Musculoskeletal and connective tissue disorders
Back pain, Rotator cuff syndrome
|
0.35%
1/289
|
0.35%
1/289
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/289
|
0.35%
1/289
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER