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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003547
• Other study ID #: AMA0076-M-101
• Secondary ID: 2013-002334-21
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2013
• Last updated: May 1, 2014
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Amakem, NV
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Disease
• Eye Diseases
• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• AMA0076

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amakem, NV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days	No
Secondary	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.	7 days	Yes