Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults
ConditionOcular Hyperemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlcon Research
About this trial
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.
Eligibility criteria
Qualifiers
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 greater than 1 on a 5-point scale in both eyes prior to randomization on Day 1 (Visit 2).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
- Vehicle
Treatment groups
230 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov