Ocular HypertensionPhase 1NCT00443924
Study of INS115644 Ophthalmic Solution in Subjects With Ocular Hypertension or Glaucoma
A Phase 1 study testing INS115644 Ophthalmic Solution in people with Ocular Hypertension and Open Angle Glaucoma, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic Solution. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ocular Hypertension, Open Angle Glaucoma
- What is being tested?
- INS115644 Ophthalmic Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Apr 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 75 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
- Have normal endothelial cell counts and morphology
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 INS115644 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma
The purpose of this trial is to evaluate the safety and tolerability of INS115644 Ophthalmic Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic Solution.
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Being tested
- INS115644 Ophthalmic Solution, Placebo
- Keywords
- Bilateral ocular hypertension or early primary open angle glaucoma
- Medical subject headings
- Ocular Hypertension, Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INS115644 Ophthalmic SolutionDrug
One drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days
PlaceboDrug
One drop of placebo in each eye every 12 hours for three days
INS115644 Ophthalmic SolutionDrug
One drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
INS115644 Ophthalmic SolutionDrug
One drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
INS115644 Ophthalmic SolutionDrug
One drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Arm 1 Receives: Drug: Placebo |
| 2 | Experimental | Arm 2 Receives: Drug: INS115644 Ophthalmic Solution |
| 3 | Experimental | Arm 3 Receives: Drug: INS115644 Ophthalmic Solution |
| 4 | Experimental | Arm 4 Receives: Drug: INS115644 Ophthalmic Solution |
| 5 | Experimental | Arm 5 Receives: Drug: INS115644 Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Measured: 28 days
Changes in intraocular pressure
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2007 (estimated)
- Study startMar 2007
- 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 Ocular HypertensionStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00443924
- Sponsor's protocol ID
- P08645
- Other IDs
- 032-101
- Status last verified
- Jan 2015
- First submitted
- 5 Mar 2007
- Last updated
- 21 Jan 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 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 INS115644 Ophthalmic Solution in Subjects With Bilateral Ocular Hypertension or Early Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00443924
- Acronym / sponsor ID
- P08645
- Conditions
- Ocular Hypertension, Open Angle Glaucoma
- Keywords
- Bilateral ocular hypertension or early primary open angle glaucoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 7 Mar 2007 (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 trial is to evaluate the safety and tolerability of INS115644 Ophthalmic Solution in subjects with bilateral ocular hypertension or early primary open angle glaucoma and to investigate the intraocular pressure lowering effects of INS115644 Ophthalmic Solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: PlaceboArm 1 |
| 2 | Experimental | Drug: INS115644 Ophthalmic SolutionArm 2 |
| 3 | Experimental | Drug: INS115644 Ophthalmic SolutionArm 3 |
| 4 | Experimental | Drug: INS115644 Ophthalmic SolutionArm 4 |
| 5 | Experimental | Drug: INS115644 Ophthalmic SolutionArm 5 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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
- Have normal endothelial cell counts and morphology
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 |
|---|---|---|
| INS115644 Ophthalmic SolutionOne drop of Concentration #1 in one eye and one drop of placebo in contralateral eye every 12 hours for three days | Drug | 2 |
| PlaceboOne drop of placebo in each eye every 12 hours for three days | Drug | 1 |
| INS115644 Ophthalmic SolutionOne drop of Concentration #2 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days | Drug | 3 |
| INS115644 Ophthalmic SolutionOne drop of Concentration #3 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days | Drug | 4 |
| INS115644 Ophthalmic SolutionOne drop of Concentration #4 in one eye and one drop of placebo in the contralateral eye every twelve hours for three days | Drug | 5 |
Primary outcome
Safety and tolerability
Time frame: 28 days
Changes in intraocular pressure
Time frame: 28 days
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 21 Jan 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INS115644 Ophthalmic Solution in people with Ocular Hypertension and Open Angle 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 3 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 21 Jan 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?
Safety and tolerability (time frame: 28 days). The study lists 2 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 21 Jan 2015.