Atopic Disease (Including Allergic Conjunctivitis) Clinical Trial
Official title:
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)
| Verified date | September 2017 |
| Source | Aciex Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 512 |
| Est. completion date | October 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ora, Inc. | Andover | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Aciex Therapeutics, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 1 (Day 1) | 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. | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | |
| Primary | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 2 (Day 8) | 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. | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | |
| Primary | Tolerability of AC 170 0.24% Compared to Its Vehicle at Visit 3 (Day 22) | 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. | Upon instillation, 30 Seconds Post-Instillation, 1 minute Post-Instillation | |
| Secondary | Safety of AC 170 0.024% Compared to Its Vehicle | Safety measures (adverse events) of AC 170 0.024% compared to its vehicle were measured at Visit 1-4 and 5 (for subset of patients). | Up to 12 Weeks |