A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 Ophthalmic Solution
Overview
- Phase
- Phase 3
- Intervention
- AC-170 0.24%
- Conditions
- Healthy Subjects
- Sponsor
- Nicox Ophthalmics, Inc.
- Enrollment
- 516
- Locations
- 1
- Primary Endpoint
- Number of Treatment Related Adverse Events
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is study is evaluating the safety and tolerability of AC-170 Ophthalmic Solution
Detailed 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.
Investigators
Eligibility Criteria
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
Arms & Interventions
AC-170 0.24%
1 drop in each eye 3 times daily for up to 6 weeks
Intervention: AC-170 0.24%
AC-170 Vehicle
1 drop in each eye 3 times daily for up to 6 weeks
Intervention: AC-170 Vehicle
Outcomes
Primary Outcomes
Number of Treatment Related Adverse Events
Time Frame: up to 12 weeks
Adverse events will be measured through study completion
Tolerability of AC 170 0.24% at Visit 1 (Day 1)
Time Frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.
Tolerability of AC 170 0.24% at Visit 3 (Day 22)
Time Frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.
Tolerability of AC 170 0.24% at Visit 2 (Day 8)
Time Frame: Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation
Tolerability was assessed upon instillation of study medication, at 1 minute and 2 minutes post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.