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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating a new treatment for Primary Open-Angle Glaucoma POAG using the Hexiris Microinvasive Scleral Trephine MIST system, a medical device designed to reduce intraocular pressure IOP in adults aged 40 years or older whose glaucoma is not controlled by topical medications. This multicenter, open-label, single-arm study focuses on safety and performance, treating only one eye per participant. The study includes an initial phase with five patients treated in an operating room and a subsequent phase with twenty patients treated in a clinic setting under a slit lamp. Participants will receive treatment with the Hexiris MIST device combined with a subconjunctival injection of mitomycin C. The first five treatments occur in the operating room, after which safety data will determine if the remaining patients are treated in the clinic. The procedure is performed under topical anesthesia using a sterile technique. Postoperative care involves topical antibiotics and steroids. Follow-up visits are scheduled at the day after treatment, then at 1 week, and 1, 2, 3, 6, 9, and 12 months. During follow-up, ophthalmologists will examine the treated eye and measure intraocular pressure along with other assessments such as bleb morphology, corneal thickness, and medication use. Researchers will monitor for safety events and device performance throughout the one-year study period. The primary outcome is the change in intraocular pressure from baseline to 6 months, with several secondary outcomes tracked up to 12 months post-treatment.

Age: 40Years +All GendersPhase Not Applicable
5 locations
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Actively Recruiting

This research aims to evaluate the effectiveness and safety of two artificial tear products, Tears Naturale Free and Tears Naturale II, in adults experiencing symptoms of dry eye disease. The study focuses on assessing symptom relief and the impact of these lubricating eye drops on everyday life for individuals with mild to moderate dry eye. Participants will use one to two drops of either Tears Naturale Free or Tears Naturale II in each eye as needed over a 30-day period. The study involves three scheduled visits an initial screening and baseline clinic visit on Day 1, a telephone follow-up around Day 15, and a final in-office visit on Day 30. Both products are commercially available artificial tears designed to supplement and stabilize the tear film, with one being preservative-free and the other containing a gentle preservative. During the study, participants will be closely monitored through these visits, including assessments of dry eye symptoms using the Impact of Dry Eye on Everyday Life - Symptom Bother Module IDEEL - SB score at baseline and Day 30. Researchers will track safety and effectiveness outcomes, ensuring participants adhere to the study protocol by discontinuing other artificial tear products. The total participation time is approximately 30 days.

Age: 18Years +All GendersPhase Not Applicable
6 locations
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Actively Recruiting

Researchers are evaluating the safety and effectiveness of intravitreal injections of ONL1204 in patients who have geographic atrophy GA associated with age-related macular degeneration AMD. GA linked to AMD is a leading cause of vision loss and legal blindness worldwide, affected by factors such as aging, smoking, obesity, diet, cardiac risk lifestyle, and genetics. ONL1204 is a new type of drug designed to protect retinal cells by inhibiting a pathway that causes cell death, previously showing promise in preclinical retinal disease models. The study includes several experimental groups receiving different doses and frequencies of ONL1204 injections into the eye, including 100 or 200 micrograms every 12 weeks or 200 micrograms every 24 weeks. There are also comparison groups receiving sham injections every 12 or 24 weeks and an active comparator group receiving monthly injections of avacincaptad pegol. These treatments are given by intravitreal injection over a 48-week treatment period. Participants will attend regular study visits for up to 48 weeks, during which researchers will monitor safety and effectiveness through visual acuity tests and imaging of the retina. The primary outcome is measured from enrollment to the end of treatment at 48 weeks. Safety assessments will also be conducted throughout the study. Participants must meet specific eye health criteria and will be closely monitored for any adverse effects or changes in their condition during the study.

Age: 55Years +All GendersPhase 2
57 locations