GlaucomaPhase 1NCT00767793
A Placebo-Controlled Study of INS117548 Ophthalmic Solution in Subjects With Glaucoma (P08650)
A Phase 1 study testing INS117548 in people with Glaucoma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- INS117548
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to May 2009
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma
- Have best corrected visual acuity in both eyes of at least +0.5 or better
Who cannot join
- Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma
- Have a history of any type of intraocular surgery, except for cataract surgery
- Have had cataract surgery within three months
About this study
Official title: A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS117548 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma
The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.
- Conditions
- Glaucoma
- Being tested
- Placebo, INS117548
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
One drop in each eye every 12 hours for seven days
INS117548Drug
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
INS117548Drug
One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
INS117548Drug
One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Placebo comparator | One drop in each eye every 12 hours for seven days Receives: Drug: Placebo |
| Arm 2 | Experimental | One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days Receives: Drug: INS117548 |
| Arm 3 | Experimental | One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days Receives: Drug: INS117548 |
| Arm 4 | Experimental | One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days Receives: Drug: INS117548 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: 15
Rate of discontinuation
Measured: 15
Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters
Measured: 15
Compliance
Measured: 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionMay 2009
- Study completionMay 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 Merck Sharp & Dohme LLCThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reza Haque, MD, PhD, Study director, Medical Monitor, Inspire
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767793
- Sponsor's protocol ID
- P08650
- Other IDs
- 037-101
- Status last verified
- Oct 2015
- First submitted
- 2 Oct 2008
- Last updated
- 2 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Ascending Dose Study of INS117548 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00767793
- Acronym / sponsor ID
- P08650
- Conditions
- Glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Oct 2008 (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.
The purpose of this study is to evaluate the safety and tolerability of INS117548 ophthalmic solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Placebo comparator | Drug: PlaceboOne drop in each eye every 12 hours for seven days |
| Arm 2 | Experimental | Drug: INS117548One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
| Arm 3 | Experimental | Drug: INS117548One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
| Arm 4 | Experimental | Drug: INS117548One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma
- Have best corrected visual acuity in both eyes of at least +0.5 or better
Key exclusion criteria (3 listed)
- Are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma
- Have a history of any type of intraocular surgery, except for cataract surgery
- Have had cataract surgery within three 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 |
|---|---|---|
| PlaceboOne drop in each eye every 12 hours for seven days | Drug | Arm 1 |
| INS117548One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days | Drug | Arm 2 |
| INS117548One drop of Concentration #2 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days | Drug | Arm 3 |
| INS117548One drop of Concentration #3 in one eye and one drop of placebo in contralateral eye every 12 hours for seven days | Drug | Arm 4 |
Primary outcome
Incidence of adverse events
Time frame: 15
Rate of discontinuation
Time frame: 15
Changes in: >Ophthalmic exam parameters >Corneal thickness >Intraocular pressure >Visual Acuity >Physical exam, vital signs and laboratory parameters
Time frame: 15
Compliance
Time frame: 15
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 2 Oct 2015.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
Reza Haque, MD, PhD study director
Medical Monitor, Inspire
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INS117548 in people with Glaucoma, run by Merck Sharp & Dohme LLC.
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 2 inclusion and 3 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 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 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.
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?
Incidence of adverse events (time frame: 15). The study lists 4 primary outcomes in all. 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 2 Oct 2015.