Efficacy and Safety of FID 123472 Ophthalmic Solution for Ocular Redness in Adults

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Alcon Research
Study ID
NCT07531043
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Ocular Hyperemia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free — DRUG
    Investigational ophthalmic solution applied topically to the eye in a unit dose preservative free (UDPF) formulation
  • Vehicle — DRUG
    Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free (UDPF) formulation

Study Details

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.

Key Dates

Start date
Oct 31, 2026
Status verified
Jun 2026
Primary completion
Feb 28, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
230 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apraclonidine Ophthalmic Solution, 0.125% Unit Dose Preservative Free
    One drop in each eye on Day 1 (single dose)
  • Placebo Comparator: Vehicle
    One drop in each eye on Day 1 (single dose)

Primary Outcome Measure

Change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1 (Visit 2) [ Time Frame: Baseline (Day 1 pretreatment); 15 minutes post-instillation (Day 1) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Contact Alcon Call Center for Trial LocationsFort WorthTexas76134-

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