Trial Outcomes & Findings for Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension (NCT NCT00945958)

NCT ID: NCT00945958

Last Updated: 2021-03-09

Results Overview

Subjects with treatment emergent adverse events

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 161 participants
• Primary outcome timeframe: 24 weeks
• Results posted on: 2021-03-09

Participant Flow

This study was an extension study of previous study conducted by SPARC (CLR_09_12). This was open-label, single group assignment long-term safety study. A total of 161 subjects were enrolled in this study. From the start of the study through Week 24 (Visit 7), safety endpoints (TEAEs and change introocular pressure) were evaluated

Subjects received their first dose of the study drug at Visit 1 (Baseline Visit). A total of 149 subjects completed Study Visit 7 (End-of-Evaluations), which met FDA's recommendation of providing safety data for at least 100 subjects for at least 6 months.

Participant milestones

Measure	SPARC0913
Overall Study STARTED	161
Overall Study COMPLETED	149
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension

Baseline characteristics by cohort

Measure	SPARC0913 n=161 Participants Inhaled dose of SPARC0913. Each single dose was administered as 1, 2, 4 and 8 puffs from the inhaler.
Age, Continuous	62.5 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks

Subjects with treatment emergent adverse events

Outcome measures

Measure	SPARC n=161 Participants The number and percentage of subjects reporting a TEAE were tabulated by system organ classification and preferred terms.
Number of Subjects With AEs	140 participants

SECONDARY outcome

Timeframe: 24 weeks

Population: From the start of the study through Week 24 (Visit 7, End of Evaluations), the change in IOP is evaluated

From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured

Outcome measures

Measure	SPARC n=161 Participants The number and percentage of subjects reporting a TEAE were tabulated by system organ classification and preferred terms.
Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)	2.83 mm Hg Standard Deviation 4.20

Adverse Events

SPARC0913

Serious events: 5 serious events

Other events: 140 other events

Deaths: 0 deaths

Serious adverse events

Measure	SPARC0913 n=161 participants at risk From the start of the study through Week 24 (Visit 7, End of Evaluations) adverse events were evaluated
Vascular disorders Peripheral vascular disease	0.62% 1/161 • Number of events 1 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Nervous system disorders Acute tension headache	0.62% 1/161 • Number of events 1 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Infections and infestations Epididymitis orchitis	0.62% 1/161 • Number of events 1 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Nervous system disorders Carotid stenosis	0.62% 1/161 • Number of events 1 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Nervous system disorders Syncopal episode	0.62% 1/161 • Number of events 1 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.

Other adverse events

Measure	SPARC0913 n=161 participants at risk From the start of the study through Week 24 (Visit 7, End of Evaluations) adverse events were evaluated
Infections and infestations Influenza, Sinusitis, Conjunctivitis viral, Tooth infection	7.5% 12/161 • Number of events 15 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Nervous system disorders Dizziness,Visual field defect	3.7% 6/161 • Number of events 7 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Musculoskeletal and connective tissue disorders Osteoporosis	1.9% 3/161 • Number of events 3 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Gastrointestinal disorders Nausea	0.00% 0/161 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
General disorders Edema peripheral	1.2% 2/161 • Number of events 2 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Skin and subcutaneous tissue disorders Madarosis	0.62% 1/161 • Number of events 2 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Vascular disorders Hypertension	0.62% 1/161 • Number of events 1 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Metabolism and nutrition disorders Any PT	1.2% 2/161 • Number of events 5 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Psychiatric disorders any PT	0.62% 1/161 • Number of events 1 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.
Eye disorders Eye pain, ocular hyperemia, growh of eyelashes	87.0% 140/161 • Number of events 319 • 24 weeks Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects.

Additional Information

Dr Shravanti Bhowmik

SPARC

Email: shravanti.bhowmik@sparcmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER