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

Ocular Redness Clinical Trial

Official title:

A Double-Masked Comparison of Apraclonidine Hydrochloride Ophthalmic Solution to Vehicle for the Reduction of Ocular Redness

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444529
• Other study ID #: DEW422-C001
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 2024
• Est. completion date: February 2025

Study information

• Verified date: May 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to Vehicle, in relieving redness of the eye due to minor eye irritations. This study will be conducted in the United States.

Description:

The study will consist of six (6) scheduled visits: Screening and/or Baseline Visit (Day -7 to -1), Eligibility Confirmation/Randomization/1st Treatment Visit (Day 1), Week 2 Follow-Up Visit (Day 14), Week 4 Follow-Up Visit (Day 28), Week 8 Follow-Up/Treatment Discontinuation Visit (Day 56) and Exit Visit (Day 63). The expected individual duration of participation in the study is approximately 10 weeks with approximately 56 days of exposure to the investigational product.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Erythema
• Ocular Redness

Intervention

Drug:
• Apraclonidine Hydrochloride Ophthalmic Solution
Investigational ophthalmic solution applied topically to the eye with a dropper bottle
• Vehicle
Vehicle (inactive ingredients) applied topically to the eye with a dropper bottle

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in investigator-assessed ocular redness at 15 minutes post-instillation on Day 1	Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 10 hours post-instillation endpoint.	Day 1: Pretreatment; 15 minutes post-treatment
Primary	Mean change from baseline in investigator-assessed ocular redness at 10 hours (600 minutes) post-instillation on Day 1	Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe). This endpoint is co-primary with the 15 minutes post-instillation endpoint.	Day 1: Pretreatment; 10 hours (600 minutes) post-treatment
Secondary	Mean change from baseline in investigator-assessed ocular redness at 1 minute post-instillation on Day 1	Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).	Day 1: Pretreatment; 1 minute post-treatment
Secondary	Mean change from baseline in investigator-assessed ocular redness at 8 hours (480 minutes) post-instillation on Day 1	Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).	Day 1: Pretreatment; 8 hours (480 minutes) post-treatment
Secondary	Mean change from baseline in investigator-assessed ocular redness at 12 hours (720 minutes) post-instillation on Day 1	Ocular redness will be assessed by the investigator using a scale from 0 to 4 in half-unit increments (0=none; 4=extremely severe).	Day 1: Pretreatment; 12 hours (720 minutes) post-treatment