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

NCT02003547 | Completed Phase 1

• 2 other identifiers: AMA0076-M-1012013-002334-21
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma; Ocular Hypertension; Eye Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Safety and Tolerability

  7 days

Study Arms (4)

AMA0076 Formulation A

EXPERIMENTAL

Topical Ocular Drop BID X 1 wk

Drug: AMA0076

AMA0076 Formulation B

EXPERIMENTAL

Topical Ocular Drop BID X 1wk

Drug: AMA0076

AMA0076 Formulation C

EXPERIMENTAL

Topical Ocular Drop BID X 1 wk

Drug: AMA0076

Placebo

PLACEBO COMPARATOR

Topical Ocular Drop BID X 1 wk

Drug: Placebo

Interventions

AMA0076 DRUG

AMA0076 Formulation A; AMA0076 Formulation B; AMA0076 Formulation C

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amakem, NV: lead

Study Sites (1)

Unknown Facility

Ruddington, Nottingham, NG11 6GS, United Kingdom

Location

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Eye Diseases

Study Officials

• Stuart Mair, MD

  Quotient Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 2, 2014

Record last verified: 2014-05

Locations

GB (1)