A Comparison of the Safety and Comfort of AC-170

Aciex Therapeutics

Status and phase: Completed; Phase 1

Conditions: Normal Ocular Health

Treatments: Drug: AC-170 0.24% (Formulation 2); Drug: AC-170 0.24% (Formulation 1); Drug: AC-170 0.17%; Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II

Study type: Interventional

Funder types: Industry

Identifiers

NCT01495338

11-100-0013

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and comfort of AC-170 compared to a placebo.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able and willing to avoid the use of ocular medications or topical ocular preparations within protocol specific time period.

Exclusion criteria

• Known contraindications or sensitivities to the study medication or its components.
• Any ocular condition that, in the opinion of the investigator, could affect the subjects safety or trial parameters.
• Use of disallowed medications during the period indicated prior to the study enrollment or during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups, including a placebo group

AC-170 0.17%

Experimental group

Treatment:

Drug: AC-170 0.17%

AC-170 0.24% (Formulation 1)

Experimental group

Treatment:

Drug: AC-170 0.24% (Formulation 1)

AC-170 0.24% (Formulation 2)

Experimental group

Treatment:

Drug: AC-170 0.24% (Formulation 2)

Olopatadine hydrochloride 0.2%/Tears Naturale II

Placebo Comparator group

Treatment:

Drug: Olopatadine hydrochloride 0.2%/Tears Naturale II