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
This trial does not accept healthy volunteersQualifiers
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).
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
Design model
Parallel
Treatments tested in this trial
Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
DrugInvestigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation
Vehicle
DrugInactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative FreeExperimental treatment 1 intervention
Group B: VehiclePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 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.
Time frame
Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1)2
Change from baseline in investigator-assessed ocular redness at 840 minutes (14 hours) post-instillation on Day 2 (Visit 3)
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.
Time frame
Baseline (Day 1 pretreatment); 840 minutes (14 hours) post-instillation (Day 2)Secondary outcomes
1
Change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1 (Visit 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).
Time frame
Baseline (Day 1 pretreatment); 1 minute post-instillation (Day 1)2
Change from baseline in investigator-assessed ocular redness at 960 minutes (16 hours) post-instillation on Day 2 (Visit 3)
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).
Time frame
Baseline (Day 1 pretreatment); 960 minutes (16 hours) post-instillation (Day 2)Sponsors and contacts
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Source ClinicalTrials.gov
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