GlaucomaPhase 1/2NCT00846989
Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular Hypertension
A Phase 1/2 study testing RKI983A and Latanoprost in people with Glaucoma and Ocular Hypertension, run by Novartis Pharmaceuticals at 29 sites in United States.
Trial summary
This purpose of this study is to access the efficacy, tolerability and safety of RKI983 (0.05% and 0.10%) ophthalmic solution bid versus once daily latanoprost 0.005%, in patients with POAG or ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- RKI983A and Latanoprost
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 29 sitesUnited States
- Study dates
- Jan 2009to Apr 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females must be post-menopausal or surgically sterile, or must use concomitantly two acceptable forms of effective contraception
- Clinical diagnosis of POAG or OH
- For study eyes not previously treated with anti-glaucoma medications
- IOP must be ≥ 22 mm Hg at least at two assessment time-points at Screening, and
- IOP must be ≥ 22 mm Hg at least at two assessment time-points at Baseline, and
- IOP must be ≥ 20 mm Hg and ≤ 36 mm Hg at all Screening and Baseline assessment time-points.
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- Or for study eyes previously treated with anti-glaucoma medications
- IOP must be ≥ 14 mm Hg and ≤ 24 mm Hg at least at two assessment time-points at Screening.
- IOP must be ≥ 22 mm Hg at least at two assessment time-points at Baseline (after wash-out)
- IOP must be ≥ 20 mm Hg and ≤ 36 mm Hg at all Baseline assessment time-points
Who cannot join
- History of or current clinically significant ocular conditions in either eye that would contraindicate the use of an investigational drug or latanoprost (e.g. active intraocular inflammation), or that might affect interpretation of the results of the study.
- History or presence of clinically significant medical problems that contraindicate the use of an investigational drug or latanoprost, including but not limited to:
- Uncontrolled hypertension with systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg measured at more than one blood pressure reading at Screening or Baseline;
- myocardial infarction within the 3 months period prior to randomization;
- active severe viral infections such as active encephalitis, meningitis, hepatitis, herpes simplex, or herpes zoster (minor viral upper respiratory infections such as colds do not require exclusion.)
- Presence of moderate or severe (grade 2 or 3) conjunctival hyperemia in the study eye at Baseline Visit.
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- Argon laser trabeculoplasty or any prior IOP lowering surgery in the study eye.
- Ocular surgery in the study eye within 3 months prior to the Screening Visit.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Novartis Investigative Site
Artesia, California, 90701
Novartis Investigative Site
Atlanta, Georgia, 30342
Novartis Investigative Site
Bethpage, New York, 11714
Novartis Investigative Site
Bossier City, Louisiana, 71111
Novartis Investigative Site
Cambridge, Massachusetts, 02142
Novartis Investigative Site
Charlotte, North Carolina, 28204
Novartis Investigative Site
Charlotte, North Carolina, 28210
Novartis Investigative Site
Danbury, Connecticut, 06810
Novartis Investigative Site
El Paso, Texas, 79904
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Inglewood, California, 90301
Novartis Investigative Site
Kaneohe, Hawaii, 96744
Novartis Investigative Site
La Jolla, California, 92037
Novartis Investigative Site
Las Vegas, Nevada, 89148
Novartis Investigative Site
Louisville, Kentucky, 40217
Novartis Investigative Site
Lynbrook, New York, 11563
Novartis Investigative Site
Memphis, Tennessee, 38119
Novartis Investigative Site
Morrow, Georgia, 30260
Novartis Investigative Site
Mt. Pleasant, South Carolina, 29464
Novartis Investigative Site
Omaha, Nebraska, 68131
Novartis Investigative Site
Poway, California, 92064
Novartis Investigative Site
Rochester, New York, 14618
Novartis Investigative Site
Roswell, Georgia, 30076
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
Spokane, Washington, 99202
Novartis Investigative Site
Springfield, Missouri, 65804
Novartis Investigative Site
Stockton, California, 95207
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Tulsa, Oklahoma, 74104
About this study
Official title: A 4-week Multi-center, Single-masked, Randomized, Latanoprost-controlled, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of RKI983 (0.05% and 0.10%) Ophthalmic Solution Given Twice a Day Versus Once Daily Latanoprost 0.005%, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
This purpose of this study is to access the efficacy, tolerability and safety of RKI983 (0.05% and 0.10%) ophthalmic solution bid versus once daily latanoprost 0.005%, in patients with POAG or ocular hypertension.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- RKI983A, Latanoprost
- Keywords
- glaucoma,, primary open-angle glaucoma (POAG),, ocular hypertension (OH),, intraocular pressure (IOP)
- Medical subject headings
- Glaucoma, Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RKI983ADrug
RKI983 0.05 % twice daily
RKI983ADrug
RKI983 0.1 % twice daily
LatanoprostDrug
Latanoprost 0.005 % once a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RKI983A |
| 2 | Experimental | Not described Receives: Drug: RKI983A |
| 3 | Active comparator | Not described Receives: Drug: Latanoprost |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction of the daily average intraocular pressure (IOP) .
Measured: from Baseline to Day 29
Secondary outcomes (3)
Mean IOP reduction at each assessment time-point
Measured: from Baseline to Day 8, 15, 22 and 29
Mean reduction of the daily average IOP
Measured: from Baseline to Days 8, 15 and 22
Frequency of adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846989
- Sponsor's protocol ID
- CRKI983A2201
- Status last verified
- Feb 2013
- First submitted
- 18 Feb 2009
- Last updated
- 19 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 4-week Multi-center, Single-masked, Randomized, Latanoprost-controlled, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of RKI983 (0.05% and 0.10%) Ophthalmic Solution Given Twice a Day Versus Once Daily Latanoprost 0.005%, in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
- ClinicalTrials.gov ID
- NCT00846989
- Acronym / sponsor ID
- CRKI983A2201
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- glaucoma,, primary open-angle glaucoma (POAG),, ocular hypertension (OH),, intraocular pressure (IOP)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This purpose of this study is to access the efficacy, tolerability and safety of RKI983 (0.05% and 0.10%) ophthalmic solution bid versus once daily latanoprost 0.005%, in patients with POAG or ocular hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RKI983A |
| 2 | Experimental | Drug: RKI983A |
| 3 | Active comparator | Drug: Latanoprost |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Females must be post-menopausal or surgically sterile, or must use concomitantly two acceptable forms of effective contraception
- Clinical diagnosis of POAG or OH
- For study eyes not previously treated with anti-glaucoma medications
- Or for study eyes previously treated with anti-glaucoma medications
Key exclusion criteria (9 listed)
- History of or current clinically significant ocular conditions in either eye that would contraindicate the use of an investigational drug or latanoprost (e.g. active intraocular inflammation), or that might affect interpretation of the results of the study.
- History or presence of clinically significant medical problems that contraindicate the use of an investigational drug or latanoprost, including but not limited to:
- Presence of moderate or severe (grade 2 or 3) conjunctival hyperemia in the study eye at Baseline Visit.
- Argon laser trabeculoplasty or any prior IOP lowering surgery in the study eye.
- Ocular surgery in the study eye within 3 months prior to the Screening Visit.
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 |
|---|---|---|
| RKI983ARKI983 0.05 % twice daily | Drug | 1 |
| RKI983ARKI983 0.1 % twice daily | Drug | 2 |
| LatanoprostLatanoprost 0.005 % once a day | Drug | 3 |
Primary outcome
Mean reduction of the daily average intraocular pressure (IOP) .
Time frame: from Baseline to Day 29
3 secondary outcomes
Mean IOP reduction at each assessment time-point
Time frame: from Baseline to Day 8, 15, 22 and 29
Mean reduction of the daily average IOP
Time frame: from Baseline to Days 8, 15 and 22
Frequency of adverse events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Results for CRKI983A2201 can be found on the Novartis Clinical Trial Results website.Link provided by the sponsor.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RKI983A and Latanoprost in people with Glaucoma and Ocular Hypertension, run by Novartis Pharmaceuticals at 29 sites 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 10 inclusion and 9 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 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean reduction of the daily average intraocular pressure (IOP) . (time frame: from Baseline to Day 29). 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 19 Dec 2020.