FID 123320 for Red Eye

No longer recruiting at 9 trial locations

Overseen By Alcon Call Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Alcon Research

Must be taking: Vasoconstrictor eye drops

Disqualifiers: Ocular surgery, Lid surgery, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop, FID 123320 (Apraclonidine Hydrochloride Ophthalmic Solution 0.125%), to determine if it safely reduces eye redness from minor irritations. Participants will use either the actual eye drop or a placebo, which is a look-alike solution with no active ingredient. The trial aims to assess the treatment's effectiveness and safety for both children and adults. It suits those who have used redness relief drops before or are interested in trying over-the-counter options. Participants must have generally healthy eyes and be able to use the drops independently or with assistance. As a Phase 3 trial, this is the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have known sensitivities to the investigational drug or any required medications, you may be excluded from the trial.

Is there any evidence suggesting that FID 123320 Ophthalmic Solution is likely to be safe for humans?

Research shows that Apraclonidine Hydrochloride, the main ingredient in FID 123320, is usually well-tolerated for its intended use. Earlier studies found this ingredient effectively lowers eye pressure without major safety issues. However, some people might experience mild side effects, such as irritation, redness, itching, or tearing of the eyes. Less commonly, blurred vision or changes in vision might occur. These effects are not severe but should be noted.

Since this trial is in an advanced phase, earlier tests found the treatment to be generally safe for people, suggesting that serious side effects are likely rare. Always consult a healthcare provider if there are concerns about joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for red eye, which often include antihistamine or vasoconstrictor eye drops, FID 123320 is unique because it is an ophthalmic solution specifically designed to be administered twice daily over an extended period. Researchers are excited about FID 123320 because it targets the underlying causes of red eye rather than just offering temporary relief. This treatment aims to provide more consistent and long-term results compared to existing options, which typically focus on short-term symptom management.

What evidence suggests that FID 123320 might be an effective treatment for red eye?

Research has shown that FID 123320, a solution containing apraclonidine hydrochloride 0.125%, may help reduce red eye by decreasing redness. In this trial, participants will receive either FID 123320 or a placebo comparator. Studies have found that FID 123320 can significantly lower intraocular pressure, often linked to redness and irritation. Specifically, those who used this solution experienced a noticeable reduction in eye redness compared to those who used a placebo. Overall, the evidence suggests that FID 123320 could be a promising option for easing minor eye irritations in both children and adults. ^{1 5 6 7 8}

Who Is on the Research Team?

Sr. Clinical Trial Lead, Pharma

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for both kids and adults who have used redness relief eye drops in the past 6 months, are generally healthy with no serious eye conditions needing treatment or surgery, and can use eye drops on their own. Kids must have a parent's consent to join.

Inclusion Criteria

I am able to understand and sign the consent form.

I can put in my own eye drops.

I, and if applicable, my caregiver, can follow all study instructions and attend all visits.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive FID 123320 Ophthalmic Solution or Vehicle for 8 weeks

8 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• FID 123320

Trial Overview

The study tests FID 123320 Ophthalmic Solution against a placebo (Vehicle) to see if it's safe and works better for reducing eye redness caused by minor irritations.

How Is the Trial Designed?

Group I: FID 123320 Ophthalmic Solution Experimental Treatment 1 Intervention

1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).

Group II: Vehicle Placebo Group 1 Intervention

1 drop instilled in each eye at Visit 2 (Day 1), followed by one drop instilled in each eye twice a day (approximately 12 hours apart) Day 2 up to Visit 5 (Day 56), followed by 1 drop instilled in each eye at Visit 5 (Day 56).

FID 123320 is already approved in United States for the following indications:

Approved in United States as Apraclonidine Hydrochloride Ophthalmic Solution 0.125% for:

• Redness of the eye due to minor eye irritations

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California

Published Research Related to This Trial

1% apraclonidine hydrochloride eyedrops, when administered both before and immediately after cataract surgery, significantly reduced the increase in intraocular pressure (IOP) compared to a placebo and a single preoperative dose, although the reduction was not statistically significant.

Despite the use of apraclonidine, some patients still experienced elevated IOP post-surgery, indicating that while the medication may help, it does not completely prevent high IOP, as evidenced by two patients reaching IOPs greater than 40 mm Hg.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of 1% apraclonidine on intraocular pressure after cataract surgery. Sterk, CC., Renzenbrink-Bubberman, AC., van Best, JA.[2013]

In a study of 174 glaucoma patients, the addition of topical apraclonidine hydrochloride significantly improved intraocular pressure (IOP) control, allowing 61% of patients to avoid surgery compared to only 33.9% in the placebo group (P < .001).

Apraclonidine was found to be safe, with common side effects including conjunctival hyperemia and dry mouth, while effectively reducing IOP by at least 20% in many patients, thus postponing the need for surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical apraclonidine hydrochloride in eyes with poorly controlled glaucoma. The Apraclonidine Maximum Tolerated Medical Therapy Study Group. Robin, AL., Ritch, R., Shin, D., et al.[2018]

Apraclonidine hydrochloride 1% eye drops effectively protect the blood-aqueous barrier in rabbits from disruption caused by laser treatment, significantly reducing protein levels in the aqueous humor compared to untreated controls.

The timing of apraclonidine application is crucial; applying it before laser treatment offers complete protection, while post-treatment application is less effective, indicating its mechanism of action is most potent when administered prior to potential damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apraclonidine protection of the blood-aqueous barrier from traumatic break-down. Bonomi, L., Bellucci, R., Pagliarusco, A., et al.[2013]

Both 0.25% and 0.5% apraclonidine hydrochloride effectively lower intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, showing significant reductions from baseline over a 90-day period.

While 0.5% apraclonidine can reduce IOP comparably to 0.5% timolol 8 hours after dosing, it is less effective at reducing morning IOP after evening dosing, indicating that timolol may be a better option for controlling IOP throughout the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 90-day study of the efficacy and side effects of 0.25% and 0.5% apraclonidine vs 0.5% timolol. Apraclonidine Primary Therapy Study Group. Stewart, WC., Laibovitz, R., Horwitz, B., et al.[2019]

In a study involving normal subjects, three formulations of apraclonidine hydrochloride were compared, and all showed similar effectiveness in reducing intraocular pressure, indicating that formulation type does not significantly impact efficacy.

The 0.5% apraclonidine hydrochloride with a 16-microliter drop size was the best tolerated, while the 1% formulation caused more frequent dry mouth and the hydroxypropylmethylcellulose formulation led to blurred vision, highlighting the importance of side effect profiles in treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reformulation and drop size of apraclonidine hydrochloride. Vocci, MJ., Robin, AL., Wahl, JC., et al.[2019]

Topical 1% apraclonidine hydrochloride significantly reduced intraocular pressure (IOP) by an average of 6.5 mm Hg (37.3%) in the treated eye, demonstrating its efficacy in lowering IOP.

The treatment also caused a notable decrease in IOP in the untreated eye (2.7 mm Hg), but side effects like eyelid retraction and conjunctival blanching were observed, indicating the need for monitoring during use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of unilateral 1% apraclonidine therapy. Robin, AL.[2019]

In a study involving 32 participants (15 normal volunteers and 17 with increased intraocular pressure), both 0.5% and 1.0% apraclonidine hydrochloride significantly reduced intraocular pressure, with the 1.0% concentration achieving a maximum decrease of 31.3% in high-pressure eyes.

There was no significant difference in efficacy between the two concentrations, as both effectively lowered intraocular pressure by over 20% in most subjects, indicating that either concentration can be used safely and effectively for managing intraocular pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A limited comparison of apraclonidine's dose response in subjects with normal or increased intraocular pressure. Abrams, DA., Robin, AL., Crandall, AS., et al.[2019]

A study involving 20 normal volunteers found that a single drop of 1% apraclonidine significantly reduced intraocular pressure (IOP) in both treated and contralateral eyes, indicating its efficacy as an ocular hypotensive agent.

While most participants experienced minor side effects like conjunctival blanching and slight upper lid retraction, one individual developed a mechanical entropion and corneal abrasion, highlighting a potential risk that may be more pronounced in certain populations, such as Asians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of adverse reactions of aponidine hydrochloride ophthalmic solution. Lin, SL., Liang, SS.[2018]

In a study involving 20 normal human subjects, topical application of apraclonidine hydrochloride significantly reduced aqueous humor flow by 35% and intraocular pressure (IOP) by 34% compared to control eyes, indicating its efficacy in lowering IOP.

Apraclonidine did not significantly affect the permeability of the blood-aqueous barrier, suggesting that its mechanism of action primarily involves reducing aqueous humor production rather than altering barrier function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aqueous flow is reduced by the alpha-adrenergic agonist, apraclonidine hydrochloride (ALO 2145). Gharagozloo, NZ., Relf, SJ., Brubaker, RF.[2019]

In a study involving 20 patients with elevated intraocular pressure, apraclonidine hydrochloride significantly reduced intraocular pressure by an average of 27% with the 0.5% and 0.25% concentrations, lowering it from 24.9 mm Hg to 16.2 mm Hg.

The higher concentrations (0.5% and 0.25%) were more effective than the lower 0.125% concentration, and while some patients experienced mild side effects like dry nose or mouth, blood pressure and pulse remained stable, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apraclonidine. A one-week dose-response study. Jampel, HD., Robin, AL., Quigley, HA., et al.[2019]

A study comparing 1% and 0.5% apraclonidine hydrochloride for controlling intraocular pressure (IOP) after argon laser trabeculoplasty (ALT) found no significant difference in effectiveness between the two concentrations.

Both concentrations were equally effective in preventing IOP rise, suggesting that the lower 0.5% formulation can be used as an effective alternative to the 1% formulation after ALT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apraclonidine 0.5% versus 1% for controlling intraocular pressure elevation after argon laser trabeculoplasty. Threlkeld, AB., Assalian, AA., Allingham, RR., et al.[2013]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06444529

Study Details | NCT06444529 | A Double-Masked ...

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 ...

2.

withpower.com

withpower.com/trial/phase-3-ocular-redness-9-2024-745ae

FID 123320 for Red Eye · Info for Participants

This suggests that FID 123320, which is apraclonidine hydrochloride 0.125%, can be effective in managing Red Eye by reducing IOP.

3.

ctv.veeva.com

ctv.veeva.com/study/a-double-masked-comparison-of-fid-123320-ophthalmic-solution-to-vehicle-for-the-reduction-of-ocular

A Double-Masked Comparison of FID 123320 Ophthalmic ...

The purpose of this study is to assess the safety and efficacy of Apraclonidine Hydrochloride Ophthalmic Solution 0.125% when compared to ...

4.

centerwatch.com

centerwatch.com/clinical-trials/listings/NCT06538662/an-investigation-of-fid-123320-for-the-reduction-of-ocular-redness-in-pediatric-and-adult-populations

An Investigation of FID 123320 for the Reduction of Ocular ...

The purpose of this study is to assess the safety and efficacy of FID 123320 Ophthalmic Solution compared to Vehicle for relieving redness ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/7573299/

Short-term efficacy of apraclonidine hydrochloride added to ...

Conclusion: Apraclonidine appeared to be safe in all eyes and efficacious in some eyes. It significantly lowered intraocular pressure when used in combination ...

6.

medline.com

medline.com/media/catalog/Docs/MSDS/MSD_SDSD12941.pdf

SDS: Apraclonidine Ophthalmic Solution, USP 0.5%

Eye, skin, gastrointestinal and/or respiratory tract irritation are possible. Medical Conditions Aggravated by Exposure: Hypersensitivity to apraclonidine or ...

7.

mms.image.mckesson.com

mms.image.mckesson.com/CumulusWeb/Click_and_learn/MSDS_9AKORN_17478071610_17478071611_APRACLONIDINE_OPHTHALMIC_SOLUTION_USP.pdf

MSDS: Apraclonidine Ophthalmic Solution USP, 0.5%

Principal Hazardous Ingredients: Apraclonidine Hydrochloride. Eyes: May cause eye irritation. Systemically absorbed by this route. Skin: May cause skin ...

8.

mayoclinic.org

mayoclinic.org/drugs-supplements/apraclonidine-ophthalmic-route/description/drg-20062024

Apraclonidine (ophthalmic route) - Side effects & dosage

For 0.5% apraclonidine. More common. Allergic reaction (redness, itching, tearing of the eye). Less common. Blurred vision or change in vision ...