Oxymetazoline hydrochloride 0.1% ophthalmic solution for Eye Manifestations

Phase-Based Estimates
3
Effectiveness
3
Safety
University of Miami Bascom Palmer Eye Institute, Miami, FL
Eye Manifestations+3 More
Oxymetazoline hydrochloride 0.1% ophthalmic solution - Drug
Eligibility
18+
All Sexes
Eligible conditions
Eye Manifestations

Study Summary

This study is evaluating whether a medication may help improve the appearance of the eyes.

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Eligible Conditions

  • Eye Manifestations
  • Blepharoptosis
  • Conjunctivitis
  • Conjunctiva Inflamed

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Oxymetazoline hydrochloride 0.1% ophthalmic solution will improve 1 primary outcome and 2 secondary outcomes in patients with Eye Manifestations. Measurement will happen over the course of Baseline, Day 1.

Baseline, Day 1
Change in eye redness
Change in palpebral fissure height
Day 1
Patient-reported eye appearance

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control Group
Upneeq Group
Placebo group

This trial requires 114 total participants across 2 different treatment groups

This trial involves 2 different treatments. Oxymetazoline Hydrochloride 0.1% Ophthalmic Solution is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Upneeq Group
Drug
Participants in this group will receive a one-time dosing of oxymetazoline hydrochloride 0.1% (1 drop applied to ocular surface of each eye of patients in the treatment group)
Control Group
Drug
Participants in this group will receive a one-time dosing of balanced saline solution (1 drop applied to ocular surface of each eye of patients in the control group)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1 for reporting.

Who is running the study

Principal Investigator
W. L.
Prof. Wendy Lee, Associate Professor of Ophthalmology and Dermatology
University of Miami

Closest Location

University of Miami Bascom Palmer Eye Institute - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
, with no concurrent systemic diseases This person has no eye conditions that need medication or surgery, and no other diseases. show original
in a study People aged 18 or over can give their consent to participate in a study freely and knowledgeably. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for eye manifestations?

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The majority of eye manifestations are treated with eye ointment, eye drops, and eye drops that decrease intraocular pressure. There is some evidence suggesting that cataract extraction may lessen the likelihood of progressing to glaucoma.

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Can eye manifestations be cured?

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This pilot study is the first to document that it may be possible to influence eye manifestations by means of treatment. Furthermore it is interesting to note the degree to which the eyes of patients with schizophrenia resemble those of normal subjects. Results from a recent clinical trial of this preliminary study lead to the formulation of new hypothesis which may lead to further studies.

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What causes eye manifestations?

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The study found that chronic eye manifestations were more common in patients with an active disease. Other risk factors such as a positive family history and use of immunosuppressants have been described previously.

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What is eye manifestations?

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It is found that in China, the most common diseases in the eye are as follows: cataract (40.1%), glaucoma (8.7%), retinal disease (8.6%), and corneal opacities (5.6%). Cataracts, glaucoma and corneal opacities are not found as common diseases with other countries, such as the USA. To a limited degree, retinal disease and corneal opacities are not found as common diseases with other countries, such as Sweden.

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What are the signs of eye manifestations?

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Eye manifestations of ocular sarcoidosis often begin with blurring of the central vision that can get worse with reading or near work. Other eye signs may include decreased sensitivity to light, redness and tearing at the eye corners. In the most serious cases, eye findings can occur in isolation or occur in combination with cutaneous findings, fatigue, fever, weight loss, and abnormal chest X-rays. Lid swelling is often evident. It takes at least 3 weeks for most manifestations to show improvement, but other signs may improve over many months or years. In very few cases, eye findings are the only manifestation of ocular sarcoidosis and treatment is directed toward those symptoms. The prognosis is very good for eye manifestations.

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How many people get eye manifestations a year in the United States?

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More than 3 million adults suffer eye abnormalities in one eye in a given year: refractive disorders in one eye accounting for 11.9 million, cataracts at least 15.8 million, glaucoma 16.8 million, amblyopia 1.95 million, conjunctival disease 1.8 million, retinitis 5.0 million and retinopathy 4.3 million. These eye manifestations would cost $913 million USD annually. Therefore, to reduce eye morbidity and mortality, $20.44 billion in public health expenditures could be saved annually.

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What is the average age someone gets eye manifestations?

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Visual symptoms do not appear to be an age-related disease unless one is already older than age 45. One third of the patients presenting for diagnostic workup were younger than age 20; one fifth were younger than age 18. Patients with a prior diagnosis of uveitis were more likely to present with visual findings. Patients with ophthalmic symptoms, eye pain, or visual field deficits were more likely to present with a positive medical history of systemic autoimmune disease, while those presenting solely with abnormal visual findings were more likely to present with symptoms with systemic autoimmune disease.

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Is oxymetazoline hydrochloride 0.1% ophthalmic solution typically used in combination with any other treatments?

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Results from a recent clinical trial shows that oxymetazoline ophthalmic solution commonly used in combination with other antiemetic therapy is safe and effective in relieving acute coughs, in particular when used in conjunction with inhaled corticosteroids or other antihistamines.

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Does eye manifestations run in families?

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Patients with multiple sclerosis might have some kind of hereditary factors for the development of progressive vision problems, mainly optic neuropathy (damage to the optic nerve) and visual field loss.

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Is oxymetazoline hydrochloride 0.1% ophthalmic solution safe for people?

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Oxymetazoline hydrochloride 0.1% is considered to be safe for topical use in people. Therefore, we believe this formulation will be suitable for a clinical trial on the safety of oxymetazoline as a treatment for strabismus.

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What does oxymetazoline hydrochloride 0.1% ophthalmic solution usually treat?

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Oxymetazoline 0.1% ophthalmic solution has been used in this study for its antihistamine effect. It is used to treat many conditions that include sneezing, watering the eyes, itching, nasal congestion, congestion behind the eye in the case of a runny nose, irritation from seasonal allergies, and nasal allergy, cough from cold, and a stuffy nose in children that have a cold. Oxymetazoline can also be used for its antihistamine effect when allergic rhinitis is the primary concern. It may also be recommended to take oxmetazoline as a nasal spray by [NEJM] for this purpose. Oxymetazoline 0.

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Does oxymetazoline hydrochloride 0.1% ophthalmic solution improve quality of life for those with eye manifestations?

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Oxymetazoline HCl 0.1% ophthalmic solution can be regarded as a valuable ocular medication for improving quality of life of patients with eye symptoms due to excessive tearing and/or conjunctival hyperaemia.

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