What is the mechanism of action of this treatment?

Common treatments for Dry Eye Syndrome include anti-inflammatory agents and tear production stimulants. Anti-inflammatory treatments, such as cyclosporine and corticosteroids, reduce ocular surface inflammation, thereby improving tear production and tear film stability. Tear production stimulants, like secretagogues, enhance natural tear production by stimulating the lacrimal glands. These treatments are essential for alleviating symptoms and preventing further ocular surface damage, thereby maintaining eye health and comfort for Dry Eye Syndrome patients.

What side effects are associated with this type of intervention?

Common treatments for Dry Eye Syndrome include anti-inflammatory medications like cyclosporine and corticosteroids, as well as tear production stimulants such as pilocarpine and cevimeline. Cyclosporine can cause burning sensations, eye redness, and potential worsening of labial gland histopathology over time. Corticosteroids like loteprednol and fluorometholone may lead to increased intraocular pressure, cataract formation, and risk of infection with prolonged use. Tear production stimulants, including pilocarpine and cevimeline, can cause sweating, nausea, and increased urinary frequency. These side effects should be discussed with a healthcare provider to determine the most appropriate treatment plan.

What prior FDA approvals exist?

Several treatments for Dry Eye Syndrome have received FDA approval, focusing on anti-inflammatory properties or tear production stimulation. Cyclosporine ophthalmic emulsion (Restasis) is an anti-inflammatory that increases tear production and has shown sustained benefits in long-term use. Another approved treatment is lifitegrast (Xiidra), which also targets inflammation to improve symptoms. Additionally, varenicline nasal spray, a cholinergic agonist, has been approved for increasing tear production. These treatments highlight the FDA's focus on both anti-inflammatory mechanisms and tear production stimulation for managing Dry Eye Syndrome.

What other types of research exist?

Promising novel alternatives to IC265 for Dry Eye Syndrome patients in 2024 include DE-089C, a long-acting diquafosol ophthalmic solution, and MIM-D3, a tyrosine kinase TrkA receptor agonist. DE-089C has demonstrated significant improvements in corneal staining scores and patient adherence due to less frequent dosing. MIM-D3 has shown efficacy in reducing corneal staining and ocular discomfort. Both treatments have been evaluated for safety and efficacy in clinical trials.

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IC265 Eye Drops for Dry Eye Syndrome

Phase 2

Waitlist Available

Research Sponsored by Iacta Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 15, 43 and 85 and mean change from day 1 to day 85

Summary

This trial is testing a new treatment called IC265 for people who have dry eye disease. The goal is to see if IC265 can help keep their eyes moist and reduce irritation. Researchers will check its safety and effectiveness.

Who is the study for?

Adults with dry eye disease who have used or wanted to use eye drops for symptoms within the last 6 months. They must have certain scores on tests measuring tear production and eye redness, and a history of dry eyes for at least 6 months. People can't join if they've had recent eye surgery, wear contact lenses, or have other significant eye conditions.

What is being tested?

The trial is testing IC265 Ophthalmic Solution against a placebo solution to see if it's safe and effective in treating signs and symptoms of dry eye syndrome in adults.

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions associated with ophthalmic solutions such as irritation, discomfort, redness, or blurred vision.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 15, 43 and 85 and mean change from day 1 to day 85

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 15, 43 and 85 and mean change from day 1 to day 85

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 15, 43 and 85 and mean change from day 1 to day 85 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Conjunctival Redness

Fluorescein staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score

Lissamine green staining in the following regions: central, superior, inferior, temporal, nasal, corneal sum, conjunctival sum, and total eye score

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IC265 Ophthalmic Solution 1%Experimental Treatment1 Intervention

1 drop will be instilled in each eye twice daily.

Group II: Placebo Ophthalmic Solution (Vehicle)Placebo Group1 Intervention

1 drop will be instilled in each eye twice daily.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Dry Eye Syndrome include anti-inflammatory agents and tear production stimulants. Anti-inflammatory treatments, such as cyclosporine and corticosteroids, reduce ocular surface inflammation, thereby improving tear production and tear film stability. Tear production stimulants, like secretagogues, enhance natural tear production by stimulating the lacrimal glands. These treatments are essential for alleviating symptoms and preventing further ocular surface damage, thereby maintaining eye health and comfort for Dry Eye Syndrome patients.

Advances in the treatment of ocular dryness associated with Sjögren׳s syndrome.Preservation of tear film integrity and inhibition of corneal injury by dexamethasone in a rabbit model of lacrimal gland inflammation-induced dry eye.