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Latanoprost for Glaucoma and Ocular Hypertension
Study Summary
This trial is testing a novel contact lens drug delivery system with latanoprost to lower eye pressure. It will assess safety, tolerability, comfort & feasibility of the new method compared to eye drops.
- Ocular Hypertension
- Glaucoma
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 4 trial • 379 Patients • NCT02017327Trial Design
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- You have had a complicated cataract surgery with loss of vitreous.You have had swelling in the back of your eye or inflammation of the middle layer of your eye in the past.The thickness of the cornea in the study eye is too thin (less than 500 μm) or too thick (more than 600 μm).You have had a bad reaction to latanoprost before.You can't wear a contact lens that fits like the one provided for the week-long trial period.You have an eye infection at the time of screening.You are taking oral carbonic anhydrase inhibitors.Your dosage of oral steroid is not consistent.You are currently using topical steroids.You have had surgery for eye pressure control.You have certain eye conditions like high eye pressure or specific types of glaucoma. If you have mild to moderate glaucoma, it's defined by a specific test result.You have a condition where the cornea in your eye is swollen or not working properly.You have been using latanoprost for less than 4 weeks before the screening.Your vision in the eye that's not being studied is very poor, at least 20/400 on the eye chart.You have taken certain types of medications that weaken the immune system within the last six months or plan to take them during the study.You have signs of fluid buildup in your eye's macula as seen on a special eye scan.You have an eye condition that would make it difficult to wear a contact lens, according to the doctor.You have used certain types of eye drops in the last month, or have been using latanoprost and it has not been stable for at least 4 weeks before the screening.You have new blood vessels growing in the back of your eye.You have a condition called rubeosis iridis in your eye.You have had a herpes infection in your eye or nearby area in the past.You have a problem with your eye that makes it difficult for the doctors to see and take pictures of it.You have had surgery to correct your vision.You are using latanoprost eye drops in one of your eyes, and it is effectively controlling the pressure inside your eye.
- Group 1: Topical Latanoprost
- Group 2: Latanoprost contact lens
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Who is the target demographic for this research endeavor?
"To partake in this trial, patients must have glaucoma and be between 18 - 85 years of age. A total of 31 people will be accepted for the study."
Is the age restriction for this research trial limited to individuals under 60 years old?
"To be eligible for participation in this trial, individuals must fall between 18 and 85 years of age. There are 75 studies available to younger participants while 837 trials exist for those aged 65 and upwards."
Can Latanoprost contact lenses cause any health risks to individuals?
"The safety of Latanoprost contact lens was evaluated to be a 1, since it is currently in Phase 1 and only has limited evidence supporting its efficacy and security."
Is there an opportunity to enroll in this clinical trial at present?
"Affirmative, according to clinicaltrials.gov's records this medical study is actively seeking out participants. It was originally posted on April 3rd 2023 and has since been updated on 4/4/2023. A total of 31 patients need to be recruited for the single location hosting it."
How many individuals are being recruited for this experiment?
"Correct. The records on clinicaltrials.gov show that this medical trial, which was initialized in April 3rd of 2023, is still recruiting patients. This research initiative needs to collect data from 31 participants at a single site."
What medical conditions is Latanoprost contact lens typically utilized to treat?
"Latanoprost contact lenses are primarily prescribed for the management of open angle glaucoma. They may also be used to alleviate symptoms related to raised intraocular pressure, ineffective responses to other treatments, and chronic angle-closure glaucoma with prior laser iridoplasty or peripheral iridotomy."
Is this the inaugural examination of its kind?
"Latanoprost contact lens has been on the medical radar since 2013, when it was first trialed by Synphora AB. This marked the start of its journey to Phase 2 drug approval in 2019 and this same year saw 11 active studies launch across 8 nations with 19 cities involved."
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