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 caused by minor eye irritations.
Detailed description
Eligible subjects will be expected to attend a total of 6 in-office study visits over a period of approximately 10 weeks. Subjects will receive a single dose of study treatment in each eye (either Apraclonidine 0.125% UDPF or Vehicle) on Day 1, after which subjects will be instructed to self-administer one drop in each eye twice daily at home for a total of approximately 8 weeks (Days 2-55), with the last dose administered on Day 56 in office. Subjects will then return for the final study visit on Day 63, following a 1-week treatment discontinuation. Eye redness will be assessed before and after instillation at prespecified timepoints.
Interventions
Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free formulation
DRUGVehicle
Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free 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 ocular redness score of 0.5 unit or higher in at least one eye at Visit 1 and greater than 1 unit on a 5-point scale in both eyes prior to randomization at Visit 2. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Known contraindications or sensitivity to the use of any of the study treatment(s) or their components, or any other medication required by the protocol. * Ocular surgical interventions 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 parameters. * Use of prohibited medications, devices, or treatments as specified in the 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 | 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 600 minutes post-instillation on Day 1 | Baseline (Day 1 pretreatment); 600 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 | 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 720 minutes post-instillation on Day 1 | Baseline (Day 1 pretreatment); 720 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). |
| Change from baseline in investigator-assessed ocular redness at 30 seconds post-instillation on Day 1 | Baseline (Day 1 pretreatment); 30 seconds 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). |
| Number of subjects who achieve prespecified improvements from baseline in investigator-assessed ocular redness score in both eyes at 30 seconds post-instillation on Day 1 | Baseline (Day 1 pretreatment); 30 seconds 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). The 30-second score will be compared to the baseline score. The number of subjects with improvements as prespecified in the protocol will be reported. |
Countries
United States
Contacts
CONTACTAlcon Call Center
STUDY_DIRECTORClinical Trial Lead, Pharma
Alcon Research, LLC
Outcome results
None listed