Formulation Comparison in Normal Volunteers

A Double-masked, Crossover Study Assessing the Ocular and Systemic Safety and Systemic Absorption of Two Formulations of 0.5% AR-12286 Ophthalmic Solution in Normal Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01250197

Enrollment

Registered

2010-11-30

Start date

2010-11-30

Completion date

2010-12-31

Last updated

2010-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal Volunteers

Keywords

Normal Volunteers

Brief summary

This is a double-masked, single-center, crossover study in which normal volunteers will be randomized to receive one of two formulations of 0.5% AR-12286 Ophthalmic Solution for 8 days. Subjects will undergo a minimum 7-day washout, and then receive the alternate treatment for 8 days.

Detailed description

Not desired.

Interventions

DRUGAR-12286

Ophthalmic Solution

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Normal volunteers

Exclusion criteria

* Active ophthalmic or systemic disease

Design outcomes

Primary

Measure	Time frame	Description
Ocular safety	3 weeks	The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject symptom queries.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026