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NCT00945958
Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
Phase 3 trial testing SPARC0913 in Open Angle Glaucoma in 161 participants. Completed in 1 June 2012.
1 June 2012
Quick facts
| Lead sponsor | Sun Pharma Advanced Research Company Limited |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 161 |
| Start date | 1 November 2010 |
| Primary completion | 1 June 2012 |
| Estimated completion | 1 June 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SPARC0913 — full drug profile →
Conditions studied
- Open Angle Glaucoma — all drugs for Open Angle Glaucoma →
- Ocular Hypertension — all drugs for Ocular Hypertension →
Sponsor
Sun Pharma Advanced Research Company Limited — full company profile →
Who can join
18 and older, any sex, with Open Angle Glaucoma or Ocular Hypertension. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Number of Subjects With AEs
Time frame: 24 weeks
Subjects with treatment emergent adverse events
Sponsor's own description
The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Open-Label Extension Study Comparing Latanoprost 0.005% Without vs With Benzalkonium Chloride in Open-Angle Glaucoma or Ocular Hypertension.
Shen Lee B, Malhotra R, Sall K, Mitchell B, et al · · 2022 · cited 3× · PMID 35898518 · DOI 10.2147/opth.s367756
Verify or expand the search:
- PubMed search for NCT00945958
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Open Angle Glaucoma
Currently open trials in the same condition.
- NCT07228221 — Standalone iStent Infinite and iDose TR for Management of Moderate to Severe Open Angle Glaucoma · Phase 4 · recruiting
- NCT06883123 — Efficacy of Simbrinza and Rocklatan vs Cosopt and Latanoprost · Phase 4 · recruiting
- NCT06666855 — A Phase III Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension in China · Phase 3 · active not recruiting
- NCT06246136 — Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery · NA · recruiting
- NCT06061718 — Travoprost Intraocular Implant in Conjunction With Cataract Surgery · Phase 3 · active not recruiting
Other Sun Pharma Advanced Research Company Limited trials
Trials by the same sponsor.
- NCT04942054 — A Study in Patients With Advanced Breast Cancer · Phase 1 · terminated
- NCT04332549 — To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Rec · Phase 1 · withdrawn
- NCT04242953 — Study to Determine Safety, Tolerability and Pharmacokinetics, of SCO-120 in Healthy Male and Post-menopausal Female Subj · Phase 1 · completed
- NCT03655236 — PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase · Phase 2 · terminated
- NCT02597465 — A Randomized, Open-Label, Comparative, Parallel-Group, Multicenter Study of SPARC1507 · Phase 3 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00945958 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sun Pharma Advanced Research Company Limited
- Last refreshed: 6 March 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00945958.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing