FID 123320 for Red Eye

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

283 Participants Needed

Trial Summary

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.

What data supports the idea that FID 123320 for Red Eye is an effective drug?

The available research shows that apraclonidine hydrochloride, including the 0.125% concentration, is effective in lowering intraocular pressure (IOP), which is a key factor in treating conditions like Red Eye. In one study, all concentrations of apraclonidine significantly lowered IOP, with the 0.5% and 0.25% concentrations reducing IOP by an average of 27%. Although the 0.125% concentration was less effective than higher concentrations, it still contributed to lowering IOP. This suggests that FID 123320, which is apraclonidine hydrochloride 0.125%, can be effective in managing Red Eye by reducing IOP. ^{1 2 3 4 5}

What safety data exists for Apraclonidine Hydrochloride Ophthalmic Solution 0.125%?

The safety data for Apraclonidine Hydrochloride, including the 0.125% concentration, indicates that it significantly lowers intraocular pressure (IOP) with minimal pupillary effects and no changes in blood pressure or pulse. Some subjects reported transient dry nose or dry mouth, which may be dose-dependent. Conjunctival blanching and mydriasis were common, and upper lid retraction was frequently noted. In one case, mechanical entropion and corneal abrasion occurred. Overall, the treatment is effective in reducing IOP and protecting the blood-aqueous barrier, with some minor and rare adverse effects. ^{1 2 6 7 8}

Is the drug Apraclonidine Hydrochloride Ophthalmic Solution 0.125% a promising treatment for Red Eye?

Apraclonidine Hydrochloride is promising because it effectively lowers eye pressure, which can help with conditions like Red Eye. It has been shown to reduce eye pressure significantly in studies, making it a potential treatment option. ^{1 7 9 10 11}

What is the purpose of this trial?

The purpose of this study is to assess the safety and efficacy of FID 123320 Ophthalmic Solution compared to Vehicle for relieving redness of the eye due to minor eye irritations in pediatric and adult populations.

Research Team

Sr. Clinical Trial Lead, Pharma

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of 1% apraclonidine on intraocular pressure after cataract surgery. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Apraclonidine. A one-week dose-response study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Apraclonidine 0.5% versus 1% for controlling intraocular pressure elevation after argon laser trabeculoplasty. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Topical apraclonidine hydrochloride in eyes with poorly controlled glaucoma. The Apraclonidine Maximum Tolerated Medical Therapy Study Group. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

A limited comparison of apraclonidine's dose response in subjects with normal or increased intraocular pressure. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of adverse reactions of aponidine hydrochloride ophthalmic solution. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Aqueous flow is reduced by the alpha-adrenergic agonist, apraclonidine hydrochloride (ALO 2145). [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Apraclonidine protection of the blood-aqueous barrier from traumatic break-down. [2013]

9. United States 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. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Reformulation and drop size of apraclonidine hydrochloride. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

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