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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)
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).
Details
| Lead sponsor | Aciex Therapeutics, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 512 |
| Start date | 2014-05 |
| Completion | 2014-10 |
Conditions
- Atopic Disease (Including Allergic Conjunctivitis)
Interventions
- Drug: AC-170 0.24%
- AC-170 0%
Primary outcomes
- Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) — 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) — 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) — 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.
Countries
United States