Open Angle GlaucomaPhase 3NCT00947661
Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
A Phase 3 study testing SPARC0912 and Reference0912 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
A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. 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?
- SPARC0912 and Reference0912
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 578 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to May 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.
- Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG).
- Unmedicated IOP ≥ 22 mmHg in one or both eyes.
- Given informed consent.
- Women of child bearing potential practicing an acceptable method of birth control with a negative urine pregnancy test.
Who cannot join
- Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
- Intraocular conventional surgery or laser surgery within the past six months.
- Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months.
- Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy.
- Ocular trauma within the past 3 months.
- Progressive retinal or optic nerve disease apart from glaucoma.
Show all 14Show fewer
- Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye.
- Any abnormality preventing stable applanation tonometry.
- Use of contact lens for the duration of the study.
- Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber.
- Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications is not judged safe.
- Clinically significant systemic disease which might interfere with the study.
- History of non-compliance to medical regimens or unwilling to comply with the study protocol.
- Participation in another clinical study within the last thirty (30) days.
Trial locations and contacts
1 site in 1 country.
About this study
A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. Patients with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- SPARC0912, Reference0912
- Keywords
- glaucoma latanoprost
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC0912Drug
Eye drops, once daily, 12 weeks
Reference0912Drug
Eye drops, once daily, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| SPARC0912 | Experimental | Test drug Receives: Drug: SPARC0912 |
| Reference0912 | Experimental | Reference drug Receives: Drug: Reference0912 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure From Baseline to Week 12
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startJul 2010
- Primary completionMay 2012
- Study completionMay 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 578 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
- NCT00947661
- Sponsor's protocol ID
- CLR_09_12
- Status last verified
- Mar 2021
- First submitted
- 23 Jul 2009
- Last updated
- 9 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
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
- Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT00947661
- Acronym / sponsor ID
- CLR_09_12
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Keywords
- glaucoma latanoprost
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 578 participants (actual)
- Lead sponsor
- Sun Pharma Advanced Research Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 28 Jul 2009 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. Patients with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPARC0912 | Experimental | Drug: SPARC0912Test drug |
| Reference0912 | Experimental | Drug: Reference0912Reference drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged ≥ 18 years.
- Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG).
- Unmedicated IOP ≥ 22 mmHg in one or both eyes.
- Given informed consent.
- Women of child bearing potential practicing an acceptable method of birth control with a negative urine pregnancy test.
Key exclusion criteria (14 listed)
- Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
- Intraocular conventional surgery or laser surgery within the past six months.
- Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months.
- Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy.
- Ocular trauma within the past 3 months.
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 |
|---|---|---|
| SPARC0912Eye drops, once daily, 12 weeks | Drug | SPARC0912 |
| Reference0912Eye drops, once daily, 12 weeks | Drug | Reference0912 |
Primary outcome
Change in Intraocular Pressure From Baseline to Week 12
Time frame: 12 weeks
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)
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.
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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 SPARC0912 and Reference0912 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 5 inclusion and 14 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 30 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?
Change in Intraocular Pressure From Baseline to Week 12 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.