Ocular Hyperemia
Conditions
Keywords
Ocular Redness
Brief summary
The purpose of this study is to evaluate the efficacy and safety of an investigational ophthalmic solution in adults with ocular redness due to minor eye irritations.
Detailed description
Eligible subjects will be expected to attend a total of 3 in-office study visits over a period of approximately 1 week. Subjects will receive a single dose of the study treatment in each eye on Day 1 (Visit 2). Eye redness will be assessed before and after instillations at prespecified timepoints.
Interventions
Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation
DRUGVehicle
Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Capable of giving signed informed consent and comply with the requirements listed in the Informed Consent Form. * Willing and able to follow all instructions and attend all study visits. * History of redness relief eyedrop use within the last 6 months, or an interest in using over-the-counter redness relief drops, or would benefit from the use of redness relief drops in the investigator's opinion. * Baseline investigator-assessed ocular redness score of 0.5 or higher in at least one eye at Visit 1 when applicable and a score of greater than 1.0 in both eyes on a 5-point scale prior to randomization on Day 1 (Visit 2). * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Known contraindications or sensitivity to the use of any of the investigational product(s) or their components, or any other medication required by the protocol. * Ocular surgical intervention within 6 months prior to Visit 1 or during the study. * Any ocular condition that, in the opinion of the investigator, may compromise the subject's safety or study specific parameters. * Use of any of the prohibited medications or devices as specified in the study protocol. * Out-of-range vital signs (blood pressure and/or pulse rate) as defined in the study protocol. * Abnormal intraocular pressure. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) | Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1) | Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint. |
| Change from baseline in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on Day 2 (Visit 3) | Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2) | Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). This is a co-primary endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 2) | Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1) | Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). |
| Change from baseline in investigator-assessed ocular redness at 960 minutes (16 hours) post-instillation on Day 2 (Visit 3) | Baseline (Day 1 pretreatment); 960 minutes (16 hours) post-instillation (Day 2) | Ocular redness will be assessed by the investigator and recorded per the Ora Calibra® Ocular Hyperemia Scale, which ranges from 0 to 4 in half-point increments (0.0 = none; 1.0 = mild redness; 2.0 = moderate redness; 3.0 = severe redness; and 4.0 = extremely severe redness). Change from baseline, calculated as post-instillation minus baseline score, can range between -4 and +2.5. Positive values indicate increased ocular redness (worsening), zero indicates no change, and negative values indicate improvement (decrease in severity). |
Countries
United States
Contacts
CONTACTAlcon Call Center
STUDY_DIRECTORClinical Trial Lead, Pharma
Alcon Research, LLC
Outcome results
None listed