Open Angle GlaucomaPhase 3NCT00945958
Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing SPARC0913 in people with Open Angle Glaucoma and Ocular Hypertension, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- SPARC0913
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Jun 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged ≥18 years
- Willing to participate and giving written informed consent
- Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation
- Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma
Who cannot join
- History of allergic hypersensitivity or poor tolerance to latanoprost
- History of Substance abuse or addiction (alcohol drugs) in the past 3 years
- History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication
- Any abnormality preventing IOP measurement
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- SPARC0913
- Keywords
- Glaucoma, Ocular hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC0913Drug
One drop of SPARC0913 in affected eye once daily for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| SPARC0913 | Experimental | Not described Receives: Drug: SPARC0913 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With AEs
Subjects with treatment emergent adverse events
Measured: 24 weeks
Secondary outcomes (1)
Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)
From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startNov 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharma Advanced Research Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945958
- Sponsor's protocol ID
- CLR_09_13
- Status last verified
- May 2016
- First submitted
- 23 Jul 2009
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shen Lee B, Malhotra R, Sall K, Mitchell B, Peace J. Open-Label Extension Study Comparing Latanoprost 0.005% Without vs With Benzalkonium Chloride in Open-Angle Glaucoma or Ocular Hypertension. Clin Ophthalmol. 2022 Jul 19;16:2285-2293. doi: 10.2147/OPTH.S367756. eCollection 2022.
PubMed 35898518
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00945958
- Acronym / sponsor ID
- CLR_09_13
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Ocular hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Posted 5 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPARC0913 | Experimental | Drug: SPARC0913 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged ≥18 years
- Willing to participate and giving written informed consent
- Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation
- Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma
Key exclusion criteria (4 listed)
- History of allergic hypersensitivity or poor tolerance to latanoprost
- History of Substance abuse or addiction (alcohol drugs) in the past 3 years
- History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication
- Any abnormality preventing IOP measurement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPARC0913One drop of SPARC0913 in affected eye once daily for 24 weeks | Drug | SPARC0913 |
Primary outcome
Number of Subjects With AEs
Time frame: 24 weeks
Subjects with treatment emergent adverse events
1 secondary outcome
Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35898518Shen Lee B, Malhotra R, Sall K, Mitchell B, Peace J. Open-Label Extension Study Comparing Latanoprost 0.005% Without vs With Benzalkonium Chloride in Open-Angle Glaucoma or Ocular Hypertension. Clin Ophthalmol. 2022 Jul 19;16:2285-2293. doi: 10.2147/OPTH.S367756. eCollection 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SPARC0913 in people with Open Angle Glaucoma and Ocular Hypertension, run by Sun Pharma Advanced Research Company Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects With AEs (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00945958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021.