A Multi-Center Study Evaluating the Safety of AC-170 0.24%

Aciex Therapeutics

Status and phase: Completed; Phase 3

Conditions: Atopic Disease (Including Allergic Conjunctivitis)

Treatments: Drug: AC-170 0%; Drug: Drug: AC-170 0.24%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02132169

14-100-0006

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of AC-170 0.24% used twice daily in Healthy Adult Subjects and in Pediatric subjects with a history or family history of atopic disease (including allergic conjunctivitis).

Enrollment: 512 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• at least 2 years of age
• be able to self-administer eye drops or have a parent/legal guardian available for this purpose
• if less than 18 years old have a history or family history of atopic disease (including allergic conjunctivitis)
• have ocular health within normal limits

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 trial parameters
• use of disallowed medication during the period indicated prior to the enrollment or during the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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512 participants in 2 patient groups, including a placebo group

AC-170 0.24%

Experimental group

Treatment:

Drug: Drug: AC-170 0.24%

AC-170 0%

Placebo Comparator group

Treatment:

Drug: AC-170 0%