GlaucomaPhase 1NCT00515424
Tolerability, Safety and Efficacy of RKI983 Eye Drops in Subjects With Primary Open Angle Glaucoma and Ocular Hypertension
A Phase 1 study testing RKI983 in people with Glaucoma and Ocular Hypertension, run by Novartis at 5 sites in United States.
Trial summary
This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with ocular hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- RKI983
- How many people
- 90 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2007to not given
- Phase
- Phase 1
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
- Adult, Older adult
Who may be able to join
- Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension
- Females must be post-menopausal or surgically sterile
Who cannot join
- Other types of glaucoma
- Eye pressure lowering surgeries
- A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Artesia, California
Study site
Charlotte, North Carolina
Study site
Durham, North Carolina
Study site
Houston, Texas
Study site
Rochester, New York
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Latanoprost-Controlled, Parallel Group Study to Assess the Tolerability, Safety and Efficacy of RKI983 Ophthalmic Solution Given Twice a Day Over One Week in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with ocular hypertension.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- RKI983
- Keywords
- Glaucoma, Ocular Hypertension, RKI983, Primary Open Angle Glaucoma and Ocular Hypertension
- 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.
RKI983Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment.
Secondary outcomes (1)
Change in ocular hypertension from Baseline to Day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startJul 2007
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Independent Central IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515424
- Sponsor's protocol ID
- CRKI983A2101
- Status last verified
- Dec 2007
- First submitted
- 9 Aug 2007
- Last updated
- 28 Dec 2007
- Results posted
- No