A Multi-Center, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution

N

NicOx

Status and phase

Completed
Phase 3

Conditions

Healthy Subjects

Treatments

Drug: AC-170 0.24%
Drug: AC-170 Vehicle

Study type

Interventional

Funder types

Industry

Identifiers

NCT02756624
15-100-0010

Details and patient eligibility

About

This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution

Full description

Central Cornea Endothelial Cell Counts will be done on a subset of approximately 150 subjects to complete 100 subjects as part of the safety measures.

Enrollment

516 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
  • be pregnant, nursing, or planning a pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

516 participants in 2 patient groups, including a placebo group

AC-170 0.24%
Experimental group
Description:
1 drop in each eye 3 times daily for up to 6 weeks
Treatment:
Drug: AC-170 0.24%
AC-170 Vehicle
Placebo Comparator group
Description:
1 drop in each eye 3 times daily for up to 6 weeks
Treatment:
Drug: AC-170 Vehicle

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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