Age-Related Macular DegenerationPhase 1NCT02076919
First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration
A Phase 1 study testing LHA510 Ophthalmic Suspension in people with Age-Related Macular Degeneration, run by Alcon Research.
Trial summary
The purpose of this first-in-human study is to assess the local ocular and systemic safety and tolerability of LHA510 eye drops when administered at various concentrations and dosing frequencies. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- LHA510 Ophthalmic Suspension
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jun 2014
- Phase
- Phase 1
- 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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- Vital signs within the following ranges:
- oral body temperature between 35.0-37.5 °C
- systolic blood pressure, 90-150 mm Hg
- diastolic blood pressure, 50-90 mm Hg
- pulse rate, 40 - 100 bpm.
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- Weigh at least 50 kg.
- Able to communicate well with the investigator.
- Able to understand and comply with the requirements of the study.
- Additional eligibility criteria for Part 2 (AMD subjects):
- Evidence of AMD in one or both eyes.
- Age 55-90.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any currently active ocular condition that requires use of topical eye drops.
- Use of contact lens over the course of the study.
- Abnormal corneal examination results at screening or eligibility.
- History of any ocular surgery within the past 6 months prior to study participation.
- Use of other investigational drugs within 30 days of enrollment.
- History of hypersensitivity or allergy to any of the study drugs (including fluorescein) or to drugs of similar chemical classes.
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- History of clinically significant ECG abnormalities, or any ECG abnormality at screening or eligibility.
- Known history or current clinically significant arrhythmias.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years.
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential.
- Use of any prohibited medication as specified in the protocol.
- Donation or loss of 400 ml or more of blood within eight (8) weeks prior to initial dosing.
- Low hemoglobin levels at screening or eligibility as specified in the protocol.
- Significant illness as specified in the protocol.
- History of drug or alcohol abuse within the 12 months prior to dosing.
- Additional exclusion criteria for Part 1 (healthy subjects):
- Abnormal thickness of the central retinal subfield on OCT at screening.
- History of any chronic eye disease other than refractive error, incipient cataract, strabismic amblyopia, or anisometropic amblyopia.
- Additional exclusion criteria for Part 2 (AMD subjects):
- Any of the following treatments to the study eye within 28 days prior to dosing: ranibizumab (Lucentis®), aflibercept (Eylea®), bevacizumab (Avastin®), pegaptanib (Macugen®), or any other VEGF inhibitor.
- Patients who have required and received regular monthly injections of these drugs in the months preceding the study.
About this study
Official title: A Randomized, Double-Masked, Vehicle-Controlled, First-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Topically Delivered LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration
The purpose of this first-in-human study is to assess the local ocular and systemic safety and tolerability of LHA510 eye drops when administered at various concentrations and dosing frequencies.
Read the detailed description
This first-in-human study was conducted in two parts. Part 1 was a single ascending dose (SAD) design to assess the local ocular and systemic safety and tolerability of a single topical eye drop of LHA510 administered at various concentrations. Four separate cohorts of unique elderly subjects (55 to 80 years) were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a 3:1 ratio as a single dose. A disposition evaluation was performed 7 days later. Part 2 was a multiple ascending dose (MAD) design to assess the local ocular and systemic safety and tolerability of LHA510 administered at various concentrations and dosing frequencies. Six separate cohorts of unique AMD subjects were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a 3:1 ratio for 7 days. A disposition evaluation was performed 14 days after the first dose of study drug. A review of all available safety data was conducted by the Sponsor and the PI(s) prior to dose escalation (cohort progression). The same concentrations levels were used in Part 1 and Part 2 and are ordered as Lowest, Next Lowest, Next Highest, and Highest.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- LHA510 Ophthalmic Suspension, LHA510 Vehicle
- Keywords
- LHA510, First in human, Safety, Tolerability, Pharmacokinetics, Elderly, Age-Related Macular Degeneration, AMD, Ocular, Eye drop
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHA510 Ophthalmic SuspensionDrug
Ophthalmic suspension in 4 concentration levels topically administered in Part 1 and Part 2
LHA510 VehicleDrug
Inactive ingredients used for masking purposes
| Study group | Role | What they receive |
|---|---|---|
| LHA510 Part 1 | Experimental | LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1 Receives: Drug: LHA510 Ophthalmic Suspension |
| LHA510 Vehicle Part 1 | Placebo comparator | Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1 Receives: Drug: LHA510 Vehicle |
| LHA510 Part 2 | Experimental | LHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2 Receives: Drug: LHA510 Ophthalmic Suspension |
| LHA510 Vehicle Part 2 | Placebo comparator | Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2 Receives: Drug: LHA510 Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1
A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: From time of consent until 30 days after stopping the trial/study drug
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2
A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: From time of consent until 30 days after stopping the trial/study drug
Number of Subjects Experiencing a Non-serious Adverse Event, Part I
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Measured: From time of consent until 30 days after stopping the trial/study drug
Number of Subjects Experiencing a Non-serious Adverse Event, Part 2
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Measured: From time of consent until 30 days after stopping the trial/study drug
Secondary outcomes (10)
The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method.Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
Measured: Up to Day 15
The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
Measured: Up to Day 15
The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [Mass x Time/Volume] (AUClast), Part 2
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
Measured: Up to Day 15
The Terminal Elimination Half-life [Time] (T1/2), Part 2
Plasma concentrations were quantitated using a high performance liquid chromatography/tandem mass spectometry method. Timepoints of assessment for Arms 1-4 were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose; and Day 15: 0h. Timepoints of assessment for LHA Highest BID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h and 12h post-dose; and Day 15: 0h. Timepoints of assessment for LHA510 Highest TID were Days 1 and 7: 0h (pre-dose), 0.25h, 0.5h, 1h, 2h, 4h, 0h (pre-2nd dose), 0.5h, 2h, 0h (pre-3rd dose), 0.25h, 0.5h, 1h, 2h, 4h, 12h post-dose; and Day 15: 0h.
Measured: Up to Day 15
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1
Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Measured: Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1
Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Measured: Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1
Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Measured: Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2
Diastolic blood pressure (pressure in the arteries when the heart rests between beats) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Measured: Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2
Systolic blood pressure (pressure when the heart is contracting) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Measured: Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2
Mean arterial blood pressure (average pressure in the arteries during one cardiac cycle) was measured using an automated validated device, with an appropriately sized cuff, and assessed in the sitting position after the subject had rested for at least 3 minutes, and again (when required) after 3 minutes in the standing position.
Measured: Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014
- Study completionJun 2014
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 Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Maietta, BSc, Study director, Alcon Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076919
- Sponsor's protocol ID
- C-13-007
- Status last verified
- Mar 2016
- First submitted
- 28 Feb 2014
- Last updated
- 1 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Vehicle-Controlled, First-in-Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of Topically Delivered LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02076919
- Acronym / sponsor ID
- C-13-007
- Conditions
- Age-Related Macular Degeneration
- Keywords
- LHA510, First in human, Safety, Tolerability, Pharmacokinetics, Elderly, Age-Related Macular Degeneration, AMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Posted 4 Sep 2015
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 first-in-human study is to assess the local ocular and systemic safety and tolerability of LHA510 eye drops when administered at various concentrations and dosing frequencies.
Detailed description
This first-in-human study was conducted in two parts. Part 1 was a single ascending dose (SAD) design to assess the local ocular and systemic safety and tolerability of a single topical eye drop of LHA510 administered at various concentrations. Four separate cohorts of unique elderly subjects (55 to 80 years) were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a 3:1 ratio as a single dose. A disposition evaluation was performed 7 days later. Part 2 was a multiple ascending dose (MAD) design to assess the local ocular and systemic safety and tolerability of LHA510 administered at various concentrations and dosing frequencies. Six separate cohorts of unique AMD subjects were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a 3:1 ratio for 7 days. A disposition evaluation was performed 14 days after the first dose of study drug. A review of all available safety data was conducted by the Sponsor and the PI(s) prior to dose escalation (cohort progression). The same concentrations levels were used in Part 1 and Part 2 and are ordered as Lowest, Next Lowest, Next Highest, and Highest.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LHA510 Part 1 | Experimental | Drug: LHA510 Ophthalmic SuspensionLHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1 |
| LHA510 Vehicle Part 1 | Placebo comparator | Drug: LHA510 VehicleInactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1 |
| LHA510 Part 2 | Experimental | Drug: LHA510 Ophthalmic SuspensionLHA510 Ophthalmic Suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2 |
| LHA510 Vehicle Part 2 | Placebo comparator | Drug: LHA510 VehicleInactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2 |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Provide written informed consent.
- Vital signs within the following ranges:
- Weigh at least 50 kg.
- Able to communicate well with the investigator.
- Able to understand and comply with the requirements of the study.
Key exclusion criteria (22 listed)
- Any currently active ocular condition that requires use of topical eye drops.
- Use of contact lens over the course of the study.
- Abnormal corneal examination results at screening or eligibility.
- History of any ocular surgery within the past 6 months prior to study participation.
- Use of other investigational drugs within 30 days of enrollment.
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 |
|---|---|---|
| LHA510 Ophthalmic SuspensionOphthalmic suspension in 4 concentration levels topically administered in Part 1 and Part 2 | Drug | LHA510 Part 1, LHA510 Part 2 |
| LHA510 VehicleInactive ingredients used for masking purposes | Drug | LHA510 Vehicle Part 1, LHA510 Vehicle Part 2 |
Primary outcome
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1
Time frame: From time of consent until 30 days after stopping the trial/study drug
A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 2
Time frame: From time of consent until 30 days after stopping the trial/study drug
A serious adverse event (SAE) was defined as any event which is fatal or life-threatening, which requires or prolongs hospitalization, which is significantly or permanently disabling or incapacitating, which constitutes a congenital anomaly or a birth defect, or which is medically significant, may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Subjects Experiencing a Non-serious Adverse Event, Part I
Time frame: From time of consent until 30 days after stopping the trial/study drug
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
Number of Subjects Experiencing a Non-serious Adverse Event, Part 2
Time frame: From time of consent until 30 days after stopping the trial/study drug
An adverse event (AE) was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. An AE, therefore, could be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment.
10 secondary outcomes
The Observed Maximum Plasma (or Serum or Blood) Concentration Following Drug Administration [Mass / Volume] (Cmax), Part 2
Time frame: Up to Day 15
The Time to Reach the Maximum Concentration After Drug Administration [Time] (Tmax), Part 2
Time frame: Up to Day 15
The Area Under the Plasma (or Serum or Blood) Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [Mass x Time/Volume] (AUClast), Part 2
Time frame: Up to Day 15
The Terminal Elimination Half-life [Time] (T1/2), Part 2
Time frame: Up to Day 15
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 1
Time frame: Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 1
Time frame: Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Change From Baseline in Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 1
Time frame: Day 1: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Change From Baseline in Diastolic Blood Pressure at Each Post Dose Timepoint, Part 2
Time frame: Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Change From Baseline in Systolic Blood Pressure at Each Post Dose Timepoint, Part 2
Time frame: Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Change From Mean Arterial Blood Pressure at Each Post Dose Timepoint, Part 2
Time frame: Day 1 and 7: 0.25h, 0.5h, 1h, 2h, 4h, 6h, 8h, 12h and 24h post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2016.
- 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.
Robert Maietta, BSc study director
Alcon Research
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LHA510 Ophthalmic Suspension in people with Age-Related Macular Degeneration, run by Alcon Research.
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 13 inclusion and 22 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 1 Apr 2016. 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?
Yes. Results are posted in the registry (first posted 4 Sep 2015). 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?
Number of Subjects With a Serious Adverse Event That, in the Opinion of the Investigator, is Related to the Study Drug, Part 1 (time frame: From time of consent until 30 days after stopping the trial/study drug). 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 1 Apr 2016.