Ocular Redness
Conditions
Keywords
Eye redness, Irritated eyes
Brief summary
The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle, in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.
Detailed description
The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.
Interventions
DRUGApraclonidine Hydrochloride Ophthalmic Solution
Investigational ophthalmic solution applied topically to the eye with a dropper bottle
DRUGVehicle
Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle
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; * Willing and able to follow all instructions and attend all study visits; * Able to self-administer eye drops- in the opinion of the investigator; * History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief; * Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study; * Ocular health within normal limits, including best-corrected visual acuity (BCVA) of 20/40 or better in each eye as measured using a Snellen chart; * Ocular redness at baseline as specified in the protocol; * Other protocol-specified inclusion criteria may apply. Key
Exclusion criteria
* Known contraindications or sensitivities to the use of any of the investigational drug(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; * Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters (i.e., could affect ocular redness, intraocular pressure, or eyelid position); * Disallowed medications or devices as specified in the protocol; * Planned surgery (ocular or systemic) during the study period or within 30 days after the study period; * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 | Day 1: Pretreatment; 15 minutes post-treatment | Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 10 hours post-instillation endpoint. |
| Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1 | Day 1: Pretreatment; 10 hours (600 minutes) post-treatment | Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 15 minutes post-instillation endpoint. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 | Day 1: Pretreatment; 1 minute post-treatment | Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). |
| Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1 | Day 1: Pretreatment; 8 hours (480 minutes) post-treatment | Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). |
| Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1 | Day 1: Pretreatment; 12 hours (720 minutes) post-treatment | Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). |
Countries
United States
Outcome results
None listed