A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects

Sponsor

Amakem, NV (Industry)

Overall Status

Completed

CT.gov ID

NCT02003547

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Ocular Hypertension Eye Disease	Drug: AMA0076 Drug: Placebo	Phase 1

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

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3 Ophthalmic Formulations of AMA0076 in Healthy Subjects

Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMA0076 Formulation A Topical Ocular Drop BID X 1 wk	Drug: AMA0076
Experimental: AMA0076 Formulation B Topical Ocular Drop BID X 1wk	Drug: AMA0076
Experimental: AMA0076 Formulation C Topical Ocular Drop BID X 1 wk	Drug: AMA0076
Placebo Comparator: Placebo Topical Ocular Drop BID X 1 wk	Drug: Placebo

Outcome Measures

Primary Outcome Measures

Intraocular Pressure [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.

Secondary Outcome Measures

Safety and Tolerability [7 days]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Ruddington	Nottingham	United Kingdom	NG11 6GS

Sponsors and Collaborators

Amakem, NV

Investigators

Principal Investigator: Stuart Mair, MD, Quotient Clinical

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Amakem, NV

ClinicalTrials.gov Identifier:

NCT02003547

Other Study ID Numbers:

AMA0076-M-101
2013-002334-21

First Posted:

Dec 6, 2013

Last Update Posted:

May 2, 2014

Last Verified:

May 1, 2014

Additional relevant MeSH terms:

Ocular Hypertension

Eye Diseases

Study Results

No Results Posted as of May 2, 2014