Trials
Search / Trial NCT06444529

A Double-Masked Comparison of FID 123320 Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness

Launched by ALCON RESEARCH · May 31, 2024

Trial Information

Current as of February 18, 2025

Completed

Keywords

Eye Redness Irritated Eyes

ClinConnect Summary

This clinical trial is studying a new eye drop solution called FID 123320, which contains Apraclonidine Hydrochloride, to see how well it reduces redness in the eyes caused by minor irritations. The trial aims to compare this solution to a placebo (a treatment that looks the same but has no active ingredients) to find out which one works better. It is taking place in the United States and is currently looking for participants aged between 65 and 74 years old, regardless of gender.

To participate, individuals need to be able to provide informed consent and follow study instructions, including attending all visits. They should have experienced eye redness recently and be able to use eye drops on their own. Women who can become pregnant must agree to take pregnancy tests and use birth control during the study. Participants can expect to have their eye health assessed and may be asked to use the study eye drops over a certain period. It's important to note that some people may not qualify if they have certain medical conditions, have had recent eye surgeries, or are taking specific medications.

Gender

ALL

Eligibility criteria

  • Key Inclusion Criteria:
  • Capable of giving signed informed consent;
  • Willing and able to follow all instructions and attend all study visits;
  • Able to self-administer eye drops- in the opinion of the investigator;
  • History of redness relief drop use within the last 6 months, or a desire to use over-the-counter (OTC) eye drops for redness relief;
  • Females capable of becoming pregnant: Agree to urine pregnancy tests and the use of medically acceptable forms of birth control throughout the study;
  • Ocular health within normal limits, including best-corrected visual acuity (BCVA) of 20/40 or better in each eye as measured using a Snellen chart;
  • Ocular redness at baseline as specified in the protocol;
  • Other protocol-specified inclusion criteria may apply.
  • Key Exclusion Criteria:
  • Known contraindications or sensitivities to the use of any of the investigational drug(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;
  • Ocular conditions that, in the opinion of the investigator, could affect the subject's safety or study parameters (i.e., could affect ocular redness, intraocular pressure, or eyelid position);
  • Disallowed medications or devices as specified in the protocol;
  • Planned surgery (ocular or systemic) during the study period or within 30 days after the study period;
  • Other protocol-defined exclusion criteria may apply.

Trial Officials

Principal Clinical Trial Lead, Pharma

Study Director

Alcon Research, LLC

About Alcon Research

Alcon Research is a leading global company dedicated to advancing eye care through innovative research and development. As a subsidiary of Novartis, Alcon focuses on the development of cutting-edge products and therapies for vision correction and eye health, including surgical, pharmaceutical, and consumer eye care solutions. With a commitment to enhancing the quality of life for patients worldwide, Alcon Research conducts rigorous clinical trials to evaluate the safety and efficacy of its products, ensuring that they meet the highest standards of care. Through collaboration with healthcare professionals and institutions, Alcon remains at the forefront of ophthalmic advancements, driving progress in the field of vision science.

Locations

Fort Worth, Texas, United States

Cranberry Township, Pennsylvania, United States

Glendale, California, United States

Lynchburg, Virginia, United States

Garner, North Carolina, United States

Falls Church, Virginia, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0