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(3S,6S,9S,12R,15S,18S,21S,24S,30S,33S,34R)-30-Ethyl-34-[(E,2R)-Hex-4-En-2-Yl]-4,7,10,12,15,19,25,28-Octamethyl-33-(Methylamino)-6,9,18,24-Tetrakis(2-Methylpropyl)-3,21-Di(Propan-2-Yl)-1-Oxa-4,7,10,13,16,19,22,25,28,31-Decazacyclotetratriacontane-2,5,8,11,14,17,20,23,26,29,32-Undecone Hydrochloride

This article discusses a clinical trial investigating the use of Isocyclosporin A eye drops for treating Atopic Keratoconjunctivitis (AKC). The study aims to evaluate the safety and effectiveness of two different dosages of Isocyclosporin A eye drop solution compared to a placebo (vehicle) in adult patients with AKC. The trial is designed to assess improvements in symptoms such as ocular itching, tearing, and discomfort, as well as signs like conjunctival hyperemia and corneal health. This research could potentially lead to new treatment options for individuals suffering from this challenging eye condition.

Table of Contents

What is Isocyclosporin A?

Isocyclosporin A is a new medication being developed as an eye drop solution for the treatment of atopic keratoconjunctivitis (AKC). Its full chemical name is (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S,34R)-30-ethyl-34-[(E,2R)-hex-4-en-2-yl]-4,7,10,12,15,19,25,28-octamethyl-33-(methylamino)-6,9,18,24-tetrakis(2-methylpropyl)-3,21-di(propan-2-yl)-1-oxa-4,7,10,13,16,19,22,25,28,31-decazacyclotetratriacontane-2,5,8,11,14,17,20,23,26,29,32-undecone hydrochloride. It’s also known by the simpler name “Isocyclosporin A hydrochloride”.[1]

What is Atopic Keratoconjunctivitis?

Atopic keratoconjunctivitis (AKC) is a chronic, severe allergic eye condition that affects the surface of the eye and the eyelids. It’s characterized by intense itching, redness, tearing, and discomfort. In severe cases, it can lead to vision problems. AKC is often associated with other allergic conditions like atopic dermatitis (eczema).[1]

How Isocyclosporin A Works

Isocyclosporin A is believed to work by reducing inflammation in the eye. It’s a type of medication known as a calcineurin inhibitor, which can help suppress the overactive immune response that causes the symptoms of AKC. By applying it directly to the eye as drops, the medication can target the affected area with minimal effects on the rest of the body.[1]

Clinical Trial Overview

A clinical trial is currently underway to evaluate the safety and effectiveness of Isocyclosporin A eye drops for treating AKC. This is a Phase II study, which means it’s designed to test the drug’s effectiveness and find the right dosage. The trial will last 4 weeks, with a 2-week follow-up period.[1]

The study is comparing two different dosages of Isocyclosporin A to a placebo (vehicle):

  1. Isocyclosporin A twice a day (morning and afternoon) with vehicle twice a day (noon and evening)
  2. Isocyclosporin A four times a day
  3. Vehicle (placebo) four times a day

Participants are randomly assigned to one of these three groups, and neither the patients nor the doctors know which treatment each person is receiving. This helps ensure that the results are not biased.[1]

Potential Benefits

The main goal of the study is to see if Isocyclosporin A can improve eye itching in people with AKC. The researchers are also looking at other potential benefits, including:

  • Reduction in other symptoms like tearing, discomfort, mucous discharge, and sensitivity to light
  • Improvement in signs of eye inflammation
  • Better quality of life for patients with AKC
  • Improved redness of the eye
  • Healthier surface of the eye (cornea)[1]

Safety and Side Effects

An important part of this study is to evaluate the safety of Isocyclosporin A eye drops. The researchers will be monitoring for any side effects or adverse reactions throughout the trial. They will also be checking if the drops are comfortable to use and if they affect vision or the health of the cells in the eye.[1]

Who Can Participate in the Trial?

The trial is open to adults (18 years and older) who have been diagnosed with AKC in both eyes. Participants need to have significant eye itching and at least one other sign of AKC, such as inflammation of the inner eyelid or cornea. However, there are several conditions that would prevent someone from participating, including:

  • Active eye infections
  • Certain other eye conditions or recent eye surgeries
  • Pregnancy or breastfeeding
  • Use of certain medications that could interfere with the study results[1]

Conclusion

Isocyclosporin A eye drops represent a promising new treatment for atopic keratoconjunctivitis, a challenging and chronic eye condition. The ongoing clinical trial will help determine if this medication is safe and effective for people with AKC. If successful, it could provide a new option for managing this difficult-to-treat condition and improve the quality of life for those affected by AKC.[1]

Aspect Details
Study Type Phase II, multicenter, randomized, double-masked, vehicle-controlled trial
Duration 4 weeks of treatment + 2 weeks of follow-up
Participants Adult patients (≥18 years) with Atopic Keratoconjunctivitis (AKC)
Treatment Groups 1. Isocyclosporin A twice daily + vehicle twice daily
2. Isocyclosporin A four times daily
3. Vehicle four times daily (placebo)
Primary Outcome Change in ocular itching score (Visual Analogue Scale) from baseline to Week 4
Secondary Outcomes Changes in other symptoms, signs of eye inflammation, quality of life, safety assessments
Key Inclusion Criteria AKC diagnosis, specific symptom severity, stable vision
Key Exclusion Criteria Active eye infections, recent eye surgeries, certain systemic conditions

FAQ

  • What is Atopic Keratoconjunctivitis (AKC)? Atopic Keratoconjunctivitis (AKC) is a chronic, allergic eye condition that affects the conjunctiva (the clear membrane covering the white part of the eye) and the cornea (the clear front part of the eye). It is characterized by symptoms such as severe itching, tearing, discomfort, and redness of the eyes.
  • What is Isocyclosporin A? Isocyclosporin A is an investigational eye drop solution being studied for the treatment of Atopic Keratoconjunctivitis. It is a type of medication that may help reduce inflammation and alleviate symptoms associated with AKC.
  • How is the study designed? The study is a 4-week, Phase II, multicenter, randomized, double-masked, vehicle-controlled trial. Participants are randomly assigned to one of three groups: Isocyclosporin A twice daily, Isocyclosporin A four times daily, or a placebo (vehicle) four times daily. The study is followed by a 2-week follow-up period.
  • What are the main outcomes being measured in this trial? The primary outcome is the change in ocular itching score from the beginning to the end of the 4-week treatment period. Secondary outcomes include changes in other symptoms (tearing, discomfort, mucous discharge, photophobia), signs of eye inflammation, quality of life, and safety assessments.
  • Who can participate in this clinical trial? The study includes adult patients (18 years or older) diagnosed with Atopic Keratoconjunctivitis in both eyes, with specific symptom severity criteria. Participants must meet several inclusion criteria and not have any conditions listed in the exclusion criteria, such as active eye infections or recent eye surgeries.

Ongoing Clinical Trials on (3S,6S,9S,12R,15S,18S,21S,24S,30S,33S,34R)-30-Ethyl-34-[(E,2R)-Hex-4-En-2-Yl]-4,7,10,12,15,19,25,28-Octamethyl-33-(Methylamino)-6,9,18,24-Tetrakis(2-Methylpropyl)-3,21-Di(Propan-2-Yl)-1-Oxa-4,7,10,13,16,19,22,25,28,31-Decazacyclotetratriacontane-2,5,8,11,14,17,20,23,26,29,32-Undecone Hydrochloride

  • A study testing DFL24498 eye drop solution to improve eye itching in adults with atopic keratoconjunctivitis

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  • Study on the Safety and Effectiveness of Isocyclosporin A Eye Drops for Adults with Atopic Keratoconjunctivitis

    Not recruiting

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    Investigated diseases:
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Glossary

  • Atopic Keratoconjunctivitis (AKC): A chronic, allergic eye condition affecting the conjunctiva and cornea, characterized by severe itching, tearing, discomfort, and redness of the eyes.
  • Isocyclosporin A: An investigational eye drop solution being studied for the treatment of Atopic Keratoconjunctivitis, which may help reduce inflammation and alleviate symptoms.
  • Vehicle: In clinical trials, a placebo or inactive substance used as a comparison to the active treatment.
  • Conjunctiva: The clear membrane that covers the white part of the eye and the inner surface of the eyelid.
  • Cornea: The clear, dome-shaped front part of the eye that covers the iris and pupil.
  • Bulbar Conjunctival Hyperemia: Redness of the white part of the eye due to increased blood flow in the small blood vessels.
  • Punctate Keratitis: Small dots or spots of damage on the surface of the cornea, often visible with special eye staining techniques.
  • Blepharitis: Inflammation of the eyelids, often causing redness, swelling, and irritation.
  • Visual Analogue Scale (VAS): A measurement tool used to assess subjective characteristics or attitudes that cannot be directly measured, often represented as a line with two endpoint descriptors.
  • Quality of Life (QoL): A measure of an individual's overall well-being and ability to function in daily life, often assessed through standardized questionnaires in clinical trials.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-isocyclosporin-a-eye-drops-for-adults-with-atopic-keratoconjunctivitis/