FID 123320 for Red Eye
Palo Alto (17 mi)Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Alcon Research
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
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.
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.346711
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.145811
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.2391011
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
My vision is 20/40 or better with correction in both eyes.
My eyes are healthy and don't need treatment or surgery.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: FID 123320 Ophthalmic SolutionExperimental Treatment1 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: VehiclePlacebo Group1 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
Find a clinic near you
Research locations nearbySelect from list below to view details:
Canyon City EyecareAzusa, CA
Eye Research FoundationNewport Beach, CA
Vision InstituteColorado Springs, CO
CORE, Inc.Shelby, NC
More Trial Locations
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Who is running the clinical trial?
Alcon ResearchLead Sponsor
References
Reformulation and drop size of apraclonidine hydrochloride. [2019]We performed a prospective, double-masked, placebo-controlled, six-period, cross-over study in which normal subjects were randomly assigned to treatment and compared three different formulations of apraclonidine hydrochloride (the present commercially available formulation, and formulations with hydroxypropylmethylcellulose or lysolecithin). We also evaluated the efficacy of a 16-microliters and 30-microliters drop size. The magnitude and duration of decrease in intraocular pressure was comparable for all formulations. Most subjects tolerated all formulations well with only a few reporting any side effects. The best-tolerated formulation was 0.5% apraclonidine hydrochloride delivered with a 16-microliters drop size. Dry mouth developed frequently with the commercially available 1% apraclonidine solution. Blurred vision complicated the use of the formulation containing hydroxypropylmethylcellulose. Both dry mouth (P less than .05) and blurred vision (P = .004) were statistically significant side effects.
A limited comparison of apraclonidine's dose response in subjects with normal or increased intraocular pressure. [2019]We performed a multicentered, placebo-controlled, randomized, crossover study comparing the efficacy of 0.5% and 1.0% apraclonidine hydrochloride in 15 normal volunteers and 17 subjects with increased intraocular pressure. Apraclonidine 1% produced a maximum 30.4% +/- 14.0% (4.7 +/- 2.4 mm Hg) decrease in mean intraocular pressure in normal eyes and a 31.3% +/- 16.5% (7.6 +/- 4.2 mm Hg) decrease in eyes with increased pressure. Apraclonidine 0.5% produced a maximum 25.8% +/- 9.7% (4.0 +/- 1.7 mm Hg) decrease in mean intraocular pressure in normal eyes and a 27.4% +/- 16.0% (6.8 +/- 4.5 mm Hg) decrease in eyes with increased pressure. There was no statistically significant difference in mean percent intraocular pressure lowering effect between the 0.5% and 1.0% apraclonidine concentrations. Most subjects treated with apraclonidine had a greater than or equal to 20% reduction in intraocular pressure from baseline. Twelve hours after instillation of apraclonidine, nine of the normal volunteers had an intraocular pressure of 10 mm Hg or less. Apraclonidine produced the same percent intraocular pressure decrease regardless of the initial level of intraocular pressure.
Apraclonidine. A one-week dose-response study. [2019]We performed a double-masked, cross-over, dose-response study of apraclonidine hydrochloride (formerly known as ALO 2145) in 20 patients with elevated intraocular pressure (IOP). We administered three concentrations of apraclonidine (0.125%, 0.25%, 0.5%) and vehicle alone bilaterally every 12 hours for one week. Patients were examined 2, 5, and 8 hours after the initial dose, and then on day 2 and day 8. We studied IOP, pupillary diameter, interpalpebral fissure width, blood pressure, and pulse. There was a two-week washout period after each one-week session. All concentrations of apraclonidine significantly lowered IOP. The 0.5% and 0.25% concentrations had equal maximal effects, lowering IOP in each patient by an average of 27% relative to vehicle alone. This corresponded to a mean decrease in IOP of 8.7 mm Hg, from a baseline of 24.9 mm Hg to 16.2 mm Hg. The 0.5% and 0.25% concentrations were significantly more effective than the 0.125% concentration at two and eight hours. Mean interpalpebral fissure width increased in a dose-dependent fashion; the pupillary effect was minimal. Blood pressure and pulse were unchanged. Thirty percent of subjects reported transient dry nose or dry mouth. These symptoms may be dose-dependent.
Aqueous flow is reduced by the alpha-adrenergic agonist, apraclonidine hydrochloride (ALO 2145). [2019]Apraclonidine hydrochloride (ALO 2145), a clonidine derivative that does not cross the blood-brain barrier, was applied topically to one eye of each of 20 normal human subjects. The rate of aqueous humor flow and the permeability of the blood-aqueous barrier were measured by fluorophotometry. Four hours after administration, the flow rate in the apraclonidine-treated eyes was 35% lower than that measured in the control eyes. Three hours after instillation, the intraocular pressure (IOP) was 34% lower in the apraclonidine-treated eyes when compared with control eyes. Both these differences were statistically significant. The drug had little, if any, effect on blood-aqueous permeability.
Short-term effects of unilateral 1% apraclonidine therapy. [2019]A prospective, double-masked, randomized study evaluated the effects of unilateral therapy with topical 1% apraclonidine hydrochloride (aplonidine hydrochloride or ALO 2145) in 20 normal volunteers. No medications were applied to either eye during the control day. Following baseline measurements on the day of treatment, one drop of topical 1% apraclonidine hydrochloride was placed on one eye and a placebo (vehicle) was placed on the fellow eye. Intraocular pressure (IOP) measurements, pupil size, blood pressure, and pulse rate were assessed on both days at the baseline and 1, 3, 5, and 7 hours later. The 1% apraclonidine hydrochloride lowered the mean IOP (+/- SD) a maximum of 6.5 +/- 4.3 mm Hg (37.3% +/- 20.4%) from the baseline on the day of treatment. A statistically significant 2.7 +/- 3.4-mm Hg (14.9% +/- 19.0%) mean IOP decrease from the baseline was noted in the contralateral placebo-treated eye. No significant changes in the coefficient of outflow, blood pressure, or heart rate were noted. Eyelid retraction, conjunctival blanching, and mydriasis were frequently noted in eyes treated with 1% apraclonidine hydrochloride.
Apraclonidine protection of the blood-aqueous barrier from traumatic break-down. [2013]This study investigated the effects of apraclonidine hydrochloride 1% eye drops on blood-aqueous barrier in 108 pigmented rabbits. The effects of pretreatment with dapiprazole and yohimbine, and a comparison with clonidine 0.125% eye drops are also reported. The disruption of blood-aqueous barrier was obtained by argon laser burning of the iris. The degree of permeability of the barrier was deduced by the amount of proteins in aqueous humor 60 min after laser application. Intraocular pressure and pupil diameter were also studied. Protein content in aqueous humor was 0.72 +/- 0.26 g/l in control rabbits that did not receive any treatment; 5.98 +/- 4.23 g/l in rabbits instilled with placebo eye drops and treated by laser burning of iris; 0.43 +/- 0.25 g/l in rabbits that received apraclonidine eye drops prior to laser burning; 2.19 +/- 1.3 g/l in rabbits that received apraclonidine eye drops immediately after laser application; 0.35 +/- 0.08 g/l in rabbits that received apraclonidine 1% eye drops both before and after laser application. Rabbits treated with clonidine 0.125% had a protein content in aqueous humor of 5.45 +/- 2.08 g/l after laser application. Dapiprazole 0.5% eye drops prior to apraclonidine led to a protein content in aqueous humor of 1.93 +/- 2.13 g/l; yohimbine 0.3% eye drops prior to apraclonidine led to a protein content of 0.70 +/- 0.40 g/l. Protein content in aqueous humor was 0.93 +/- 0.36 g/l, 0.82 +/- 0.899 g/l and 1.68 +/- 1.39 g/l in rabbits treated with yohimbine 0.3, 0.6 and 1.2 mg/kg i.v. and then with apraclonidine 1% eye drops. In one group of rabbits, the penetration into the aqueous humor of Evans blue injected intravenously was also studied. Evans blue content in aqueous humor was 0.03 +/- 0.08 mg/100 ml in control rabbits; 0.92 +/- 0.53 mg/100 ml in placebo rabbits treated by laser; and 0.28 +/- 0.19 mg/100 ml in apraclonidine rabbits treated by laser. Apraclonidine eye drops led to a decrease in IOP and prevented IOP rise following argon laser application. Placebo treated rabbits had a 20% increase in IOP following laser application. Apraclonidine-treated eyes showed mydriasis and blanching of the conjunctiva. These effects were not affected by pretreatment with dapiprazole or yohimbine. In these experiments, the treatment with apraclonidine 1% eye drops completely protected the blood aqueous barrier from the disruption caused by laser burning of the iris. The protection was less effective when apraclonidine was applied after laser burnings.
Evaluation of adverse reactions of aponidine hydrochloride ophthalmic solution. [2018]We prospectively evaluated the adverse reactions of apraclonidine in 20 normal volunteers by instilling a single drop of 1% apraclonidine in their right eyes. Examinations, including blood pressure, pulse rate, conjunctiva and cornea, intraocular pressure (IOP), pupil diameter, basal tear secretion and margin reflex distance of both upper and lower eyelids, were performed prior to entry and at 1, 3, 5 and 7 hours after instillation. The ocular hypotensive effects were statistically significant for apraclonidine-treated eyes throughout the study and also statistically significant for contralateral eyes from three hours after topical administration of 1% apraclonidine. Decreases in systolic blood pressure were statistically, but not clinically, significant. No significant changes in diastolic blood pressure, pulse rate and basal tear secretion were noted. Conjunctival blanching and mydriasis were commonly found. Upper lid retraction was frequently noted. While the elevations of the upper lid margin in most subjects were not more than 2 mm and did not cause noticeable change in appearance, one subject suffered from mechanical entropion and marked corneal abrasion 3 hours after instillation of the medication. This may well be a particularly notable finding in Asian people.
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]To compare long-term intraocular pressure (IOP)-lowering efficacy of 0.25% and 0.5% apraclonidine hydrochloride with 0.5% timolol maleate.
Topical apraclonidine hydrochloride in eyes with poorly controlled glaucoma. The Apraclonidine Maximum Tolerated Medical Therapy Study Group. [2018]We determined whether the addition of topical apraclonidine hydrochloride to eyes receiving maximal medical therapy, with inadequate intraocular pressure (IOP) control, and scheduled to undergo surgery, could adequately lower IOP, postponing the need for surgical intervention.
Apraclonidine 0.5% versus 1% for controlling intraocular pressure elevation after argon laser trabeculoplasty. [2013]Topical apraclonidine hydrochloride 1% is effective for controlling the intraocular pressure (IOP) rise following argon laser trabeculoplasty (ALT). The 0.5% formulation has recently become available commercially. The objective of this study was to compare the efficacy of these two concentrations for controlling IOP after ALT.
The effect of 1% apraclonidine on intraocular pressure after cataract surgery. [2013]To measure the effect of 1% apraclonidine hydrochloride eyedrops on intraocular pressure (IOP) after cataract surgery. The effects of two different dosage regimens, once before surgery or once before and after surgery, were studied.