A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety of AC-170 0.24% Ophthalmic Solution Used Twice Daily in Healthy Adult Subjects and in Pediatric Subjects With a History or Family History of Atopic Disease (Including Allergic Conjunctivitis)
Overview
- Phase
- Phase 3
- Intervention
- AC-170 0%
- Conditions
- Atopic Disease (Including Allergic Conjunctivitis)
- Sponsor
- Aciex Therapeutics, Inc.
- Enrollment
- 512
- Locations
- 1
- Primary Endpoint
- Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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).
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
Arms & Interventions
AC-170 0%
Intervention: AC-170 0%
Outcomes
Primary Outcomes
Tolerability of AC 170 0.24% Compared to Its Vehicle 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 30 seconds and 1 minute 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% Compared to Its Vehicle 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 30 seconds and 1 minute 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% Compared to Its Vehicle 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 30 seconds and 1 minute post study medication instillation. Drop comfort was assessed using a 0-to 10 scale where 0=very comfortable and 10=very uncomfortable.
Secondary Outcomes
- Safety of AC 170 0.024% Compared to Its Vehicle(Up to 12 Weeks)