MedDataX Logo

Formulation Comparison in Normal Volunteers

NCT ID: NCT01250197

Last Updated: 2010-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Not desired.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Normal Volunteers

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Normal Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Formulation A

AR-12286 Ophthalmic Solution Formulation A

Group Type EXPERIMENTAL

AR-12286

Intervention Type DRUG

Ophthalmic Solution

Formulation B

AR-12286 Ophthalmic Solution Formulation B

Group Type EXPERIMENTAL

AR-12286

Intervention Type DRUG

Ophthalmic Solution

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AR-12286

Ophthalmic Solution

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Normal volunteers

Exclusion Criteria

* Active ophthalmic or systemic disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aerie Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aerie

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tom van Haarlem, MD

Role: STUDY_DIRECTOR

Aerie Pharmaceuticals, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Celerion

Phoenix, Arizona, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AR-12286-CS101

Identifier Type: -

Identifier Source: org_study_id