Formulation Comparison in Normal Volunteers

Normal Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01250197
• Other study ID #: AR-12286-CS101
• Status: Completed
• Phase: Phase 1
• First received: November 29, 2010
• Last updated: December 20, 2010
• Start date: November 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2010
• Source: Aerie Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Not desired.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Normal volunteers

Exclusion Criteria:

• Active ophthalmic or systemic disease

Study Design

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

Related Conditions & MeSH terms

• Normal Volunteers

Intervention

Drug:
• AR-12286
Ophthalmic Solution

Locations

Country	Name	City	State
United States	Celerion	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Aerie Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular safety	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.	3 weeks	Yes