GlaucomaPhase 1NCT02003547
A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
A Phase 1 study testing AMA0076 in people with Glaucoma and Ocular Hypertension, run by Amakem, NV at 1 site in United Kingdom.
Trial summary
A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma, Ocular Hypertension, Eye Disease
- What is being tested?
- AMA0076
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Dec 2013
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy males and non-pregnant, non-lactating females, aged 35 to 65 years.
- Body mass index of ≤35kg/m2.
- IOP between 15 and 24 mmHg (inclusive) in both eyes at Screening Visits 1 and 2.
Who cannot join
- Women of child-bearing potential who have a positive pregnancy test.
- Any subject deemed by the investigator to have uncontrolled systemic hypertension
- Use of systemic, inhaled or ocular corticosteroid treatment within 90 days of screening or likely to require their use during the study period.
- Any screening laboratory abnormality that, in either the investigator's or the medical monitor's judgment, is considered to be clinically significant or a safety risk.
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study, or interfere with interpretation of the subject's study results.
- Participation in any other clinical study within 1 month of screening or during the study.
Show all 24Show fewer
- Receipt of another investigational drug within 90 days of dosing in this study
- Diagnosis of any form of glaucoma.
- IOP >24 mmHg in either eye at any screening visit.
- Use of any ocular drops (including lubricating drops/artificial tears) during screening period or need for ocular drops during duration of study participation.
- In the opinion of the investigator, clinically significant eye trauma within 6 months of screening.
- Any intraocular ophthalmic procedure within 6 months of screening.
- Any ocular inflammation within 90 days of screening or a history of recurrent uveitis in either eye.
- Subjects with any known ocular disease and who are under care of a hospital ophthalmologist.
- Any condition preventing valid applanation tonometry measurement.
- Unable to discontinue contact lens wear during the study
- Visual acuity (VA) worse than 20/80 in either eye
- Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption.
- Positive drugs of abuse test result.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects
A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects
Read the detailed description
Each subject will receive the following treatments:
- Period 1: Formulation A (n = 14) or placebo (n = 7) twice daily for 7 days
- Period 2: Formulation B (n = 14) or placebo (n = 7) twice daily for 7 days
- Period 3: Formulation C (n = 14) or placebo (n = 7) twice daily for 7 days
There will be a minimum washout of 7 days between each treatment period (last dose of previous period to first dose of subsequent period
- Conditions
- Glaucoma, Ocular Hypertension, Eye Disease
- Being tested
- AMA0076, Placebo
- Medical subject headings
- Glaucoma, Ocular Hypertension, Eye Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMA0076Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AMA0076 Formulation A | Experimental | Topical Ocular Drop BID X 1 wk Receives: Drug: AMA0076 |
| AMA0076 Formulation B | Experimental | Topical Ocular Drop BID X 1wk Receives: Drug: AMA0076 |
| AMA0076 Formulation C | Experimental | Topical Ocular Drop BID X 1 wk Receives: Drug: AMA0076 |
| Placebo | Placebo comparator | Topical Ocular Drop BID X 1 wk Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular Pressure
The primary endpoint is the comparison of Intraocular Pressure assessments taken at pre-treatment on Day -1 and on Day 7 for each diurnal time point (0, 2, 4 and 8 h post-anticipated dose [Day -1] or post-dose [Day 7]) for each treatment period between active treatment and placebo.
Measured: 7 days
Secondary outcomes (1)
Safety and Tolerability
The secondary endpoints are:
- Comparison of hyperaemia assessments in each eye using a photographic rating scale on Day -1 (0 and 8 h post-anticipated dose) and Day 7 (0, 2, 4 and 8 h post dose)
- Assessment of ocular surface photographic images of each eye on Day -1 and Day 7 (0 h).
- Safety laboratory assessments, vital signs, 12-lead electrocardiogram (ECG), recording of Adverse Events and ophthalmic examination findings including visual acuity.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2013
- Study completionDec 2013
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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amakem, NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Mair, MD, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003547
- Sponsor's protocol ID
- AMA0076-M-101
- Other IDs
- 2013-002334-21
- Status last verified
- May 2014
- First submitted
- 2 Dec 2013
- Last updated
- 2 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02003547
- Acronym / sponsor ID
- AMA0076-M-101
- Conditions
- Glaucoma, Ocular Hypertension, Eye Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Amakem, NVIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 Dec 2013 (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.
A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects
Detailed description
Each subject will receive the following treatments:
- Period 1: Formulation A (n = 14) or placebo (n = 7) twice daily for 7 days
- Period 2: Formulation B (n = 14) or placebo (n = 7) twice daily for 7 days
- Period 3: Formulation C (n = 14) or placebo (n = 7) twice daily for 7 days
There will be a minimum washout of 7 days between each treatment period (last dose of previous period to first dose of subsequent period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMA0076 Formulation A | Experimental | Drug: AMA0076Topical Ocular Drop BID X 1 wk |
| AMA0076 Formulation B | Experimental | Drug: AMA0076Topical Ocular Drop BID X 1wk |
| AMA0076 Formulation C | Experimental | Drug: AMA0076Topical Ocular Drop BID X 1 wk |
| Placebo | Placebo comparator | Drug: PlaceboTopical Ocular Drop BID X 1 wk |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy males and non-pregnant, non-lactating females, aged 35 to 65 years.
- Body mass index of ≤35kg/m2.
- IOP between 15 and 24 mmHg (inclusive) in both eyes at Screening Visits 1 and 2.
Key exclusion criteria (24 listed)
- Women of child-bearing potential who have a positive pregnancy test.
- Any subject deemed by the investigator to have uncontrolled systemic hypertension
- Use of systemic, inhaled or ocular corticosteroid treatment within 90 days of screening or likely to require their use during the study period.
- Any screening laboratory abnormality that, in either the investigator's or the medical monitor's judgment, is considered to be clinically significant or a safety risk.
- History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results of the subject's ability to participate in the study, or interfere with interpretation of the subject's study results.
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 |
|---|---|---|
| AMA0076 | Drug | AMA0076 Formulation A, AMA0076 Formulation B, AMA0076 Formulation C |
| Placebo | Drug | Placebo |
Primary outcome
Intraocular Pressure
Time frame: 7 days
The primary endpoint is the comparison of Intraocular Pressure assessments taken at pre-treatment on Day -1 and on Day 7 for each diurnal time point (0, 2, 4 and 8 h post-anticipated dose [Day -1] or post-dose [Day 7]) for each treatment period between active treatment and placebo.
1 secondary outcome
Safety and Tolerability
Time frame: 7 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 2 May 2014.
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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.
Stuart Mair, MD principal investigator
Quotient Clinical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMA0076 in people with Glaucoma and Ocular Hypertension, run by Amakem, NV at 1 site in United Kingdom.
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 24 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 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
Intraocular Pressure (time frame: 7 days). 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 May 2014.