Back to resultsA Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
Primary Purpose
Glaucoma, Ocular Hypertension, Eye Disease
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AMA0076
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
AMA0076 Formulation A
AMA0076 Formulation B
AMA0076 Formulation C
Placebo
Arm Description
Topical Ocular Drop BID X 1 wk
Topical Ocular Drop BID X 1wk
Topical Ocular Drop BID X 1 wk
Topical Ocular Drop BID X 1 wk
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02003547
Brief Title
A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
Official Title
A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amakem, NV
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Ocular Hypertension, Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMA0076 Formulation A
Arm Type
Experimental
Arm Description
Topical Ocular Drop BID X 1 wk
Arm Title
AMA0076 Formulation B
Arm Type
Experimental
Arm Description
Topical Ocular Drop BID X 1wk
Arm Title
AMA0076 Formulation C
Arm Type
Experimental
Arm Description
Topical Ocular Drop BID X 1 wk
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Topical Ocular Drop BID X 1 wk
Intervention Type
Drug
Intervention Name(s)
AMA0076
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Safety and Tolerability
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Mair, MD
Organizational Affiliation
Quotient Clinical
Official's Role
Principal Investigator
Facility Information:
City
Ruddington
State/Province
Nottingham
ZIP/Postal Code
NG11 6GS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
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