UNR844 for Presbyopia

Phase-Based Estimates
1
Effectiveness
2
Safety
Novartis Investigative Site, Suita-city, Japan
Presbyopia
UNR844 - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Presbyopia

Study Summary

This study is evaluating whether a drug called UNR844 can improve vision in people with presbyopia.

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Treatment Effectiveness

Study Objectives

This trial is evaluating whether UNR844 will improve 1 primary outcome and 3 secondary outcomes in patients with Presbyopia. Measurement will happen over the course of Month 3.

Month 3
Characterize dose response of UNR844 as measured by change from baseline in monocular DCNVA at Month 3
Characterize dose-response of UNR844 for change from baseline in binocular Distance-corrected Near Visual Acuity (DCNVA) at Month 3
Evaluate the efficacy of improving DCNVA in presbyopic participants, as measured by proportion of participants gaining at least 0.3 logMAR DCNVA at Month 3
Month 12
Assess the duration of effect using change in DCNVA after Month 3 with various dose concentrations of UNR844

Trial Safety

Trial Design

5 Treatment Groups

Placebo Ophthalmic Solution
UNR844 Medium 1
Placebo group

This trial requires 235 total participants across 5 different treatment groups

This trial involves 5 different treatments. UNR844 is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

UNR844 Medium 1
Drug
UNR844 Medium 1 ophthalmic solution; one drop twice-a-day for three months
UNR844 Low
Drug
UNR844 Low ophthalmic solution; one drop twice-a-day for three months
UNR844 High
Drug
UNR844 High ophthalmic solution; one drop twice-a-day for three months
UNR844 Medium 2
Drug
UNR844 Medium 2 ophthalmic solution; one drop twice-a-day for three months
Placebo Ophthalmic Solution
Drug
placebo ophthalmic solution; one drop twice-a-day for three months

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11 and month 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly month 4, month 5, month 6, month 7, month 8, month 9, month 10, month 11 and month 12 for reporting.

Closest Location

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Need a certain level of near correction
Written informed consent must be obtained before any assessment is performed
Impaired near vision in each eye and when using both eyes, without any near correction

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 is presbyopia?

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When age-related ocular changes are taken into account, visual acuity can be retained to a great extent, even when near work is prescribed to the eye. A better understanding of the visual demands of tasks requiring near vision will assist the optometrist in planning rehabilitation.

Unverified Answer

What are the signs of presbyopia?

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The signs of presbyopia are present in more than half of the patients. The patients with higher age, greater myopia, higher near point of focus, and less near point of convergence present the signs of presbyopia earlier. There is also a strong association between signs of presbyopia and a decline in visual acuity over 4 years.

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What causes presbyopia?

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Presbyopia is an inherited condition associated with a genetic predisposition to developing presbyopia in adulthood, but there is no definite, conclusive explanation for the condition. For the individual to have presbyopia, three or more of the four major groups of risk factors need to be present: no refractive correction during childhood, high myopia at the time of refraction, high myopia in later life, and hyperopia in later life. In particular, the presence of familial disease at the time of diagnosis is crucial.

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Can presbyopia be cured?

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The treatment of presbyopia often leads to successful management of its symptoms and the ability for patients to achieve their goals in terms of their activities of daily living. However, patients often become frustrated by presbyopia.

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What are common treatments for presbyopia?

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Low level laser therapy has recently been used as a treatment for presbyopia. The majority of research that has been done so far is small and underpowered. However, this is the most popular treatment, and may be worth considering. Eye drops have not been found to be useful or safe for the treatment of presbyopia. There is a need for a larger amount of high quality research to determine if eye drops are useful as a treatment.

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How many people get presbyopia a year in the United States?

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At least 3 million Americans have presbyopia by the age of 80 years. The age of onset is increasing and there are more women in their fourth decade of life.

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How serious can presbyopia be?

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Serious cases of hyperopia in individuals aged 60 years and better can result in chronic corneal scars. Further studies into ocular injuries resulting from hyperopia are needed.

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Who should consider clinical trials for presbyopia?

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Current data suggest that presbyopic patients who are well managed and comfortable with their symptoms are likely to respond well to the pharmacologic treatment with bifocals if they are not satisfied with their current spectacle prescription.

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Does presbyopia run in families?

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The study highlights the importance of taking into account a familial component as part of an exhaustive analysis of a candidate gene-disease association study to fully explore the genetics of the phenotype and to avoid spurious results.

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Is unr844 typically used in combination with any other treatments?

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There has been a shift in the use of Unr844 in combination with other therapies. A growing number of clinical trials and publications are demonstrating improved outcomes as a result of the addition of Unr844 to currently used treatment interventions.

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What is the latest research for presbyopia?

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The latest research suggests that the effects of a combination of orthokeratology and a reading aid on reading performance may be comparable to, or even better than, a single intervention such as reading glasses. However, this conclusion is based on a small number of studies and a wide range of outcome measures. There is little evidence to justify the general application of orthokeratology for presbyopia even though it has been popular in the US and the UK. It is prudent to consider whether orthokeratology is cost effective when there is a lack of evidence on the effectiveness of orthokeratology.

Unverified Answer

What are the common side effects of unr844?

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Unr844 eye drops are well tolerated. The most common side effects are conjunctival hyperemia and tear film abnormalities such as tear film instability or superficial punctate keratopathy.

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