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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.