An Investigation of FID 123472 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness in Adults

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
Alcon Research
Study ID
NCT07578363
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 formulation
  • Vehicle — DRUG
    Inactive ingredients of FID 123472 applied topically to the eye as an ophthalmic solution in a unit dose preservative free 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 caused by minor eye irritations.

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
178 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, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office.
  • Placebo Comparator: Vehicle
    One drop in each eye on Day 1, followed by one drop in each eye twice daily (approximately 12 hours apart, but not less than 11.5 hours apart) beginning the day following Day 1 up until the day prior to Day 56. On the day of Day 56, subjects will receive the last dose in-office.

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Contact Alcon Call Center for Trial LocationsFort WorthTexas76134-

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