An Investigation of FID 123472 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness in Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free, Vehicle.
- Who it may be relevant to
- Registry conditions: Ocular Hyperemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter, Randomized, Vehicle-Controlled Evaluation of the Efficacy and Safety of FID 123472 Ophthalmic Solution for the Reduction of Ocular Redness in Adult Subjects
Overview
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
- Drug Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free formulation - Drug Vehicle
Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free formulation
Primary outcome measures
- Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 [Time frame: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)]
- Change from baseline in investigator-assessed ocular redness at 600 minutes post-instillation on Day 1 [Time frame: Baseline (Day 1 pretreatment); 600 minutes post-instillation (Day 1)]
Secondary outcome measures (3)
- Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 [Time frame: Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)]
- Change from baseline in investigator-assessed ocular redness at 720 minutes post-instillation on Day 1 [Time frame: Baseline (Day 1 pretreatment); 720 minutes post-instillation (Day 1)]
- Change from baseline in investigator-assessed ocular redness at 30 seconds post-instillation on Day 1 [Time frame: Baseline (Day 1 pretreatment); 30 seconds post-instillation (Day 1)]
Eligibility criteria
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 greater than 1 unit on a 5-point scale in both eyes prior to randomization.
- Other protocol-defined inclusion criteria may apply.
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 exclusion criteria may apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Contact Alcon Call Center for Trial Locations — Fort Worth
Identifiers
NCT: NCT07578363 · DEW261-C003