Treatment Trials

73 Clinical Trials for Various Conditions

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RECRUITING
Comparison of Conjunctival Antimicrobial Activity and Patient Comfort Between Topical Hypochlorous Acid (Avenova) and Betadine
Description

The purpose of this research study is to find out how Avenova (0.01 % hypochlorous acid) works compared to Betadine (Povidone iodide) for reducing bacteria and patient discomfort in the eyes.

COMPLETED
Can COVID-19 Persist in Intraocular Fluid?
Description

Several common viruses thrive and persist in intraocular fluid due to ocular immune privilege. Immune privilege is maintained by lack of lymphatic tissue, a strong blood ocular barrier, and regulation of the systemic immune response via immunosuppressive factors such as TGF-B and processes like anterior chamber associated immune deviation. Notable viruses that benefit from ocular immune sequestration include DNA viruses such as Herpes simplex virus, Varicella Zoster, Cytomegalovirus and RNA viruses like Ebola and Rubella.In light of the global 2019 Severe acute respiratory syndrome coronavirus-2 virus (SARS CoV-2 or commonly COVID-19) pandemic, there has been growing interest on COVID-19's long term effects on the ocular system. Ocular symptoms at the time of diagnosis and during illness have been reported previously. The most commonly reported are epiphora, chemosis, and conjunctivitis. Less common were findings of retinal hemorrhages and retinal ischemic changes. Recent literature has demonstrated its presence in ocular fluid such as tears and the aqueous humor, but whether this is sustained for an extended period of time has yet to be determined. Long term effects of covid on the neurological system are being identified - large vessel ischemic strokes, cerebral hemorrhages, cranial nerve palsies, and memory loss in young adults are being reported. The persistence of COVID 19 in the intraocular fluid several months after covid infection has not been studied previously.

COMPLETED
Safety and Efficacy of KPI-121 in Subjects With Postsurgical Inflammation
Description

The primary purpose of this study is to determine the efficacy and safety of KPI-121 ophthalmic suspension compared to placebo in subjects who have undergone cataract surgery. The efficacy and safety of two different concentrations and two different dosing regimens of KPI-121 are also being assessed.

COMPLETED
A Phase 2, Open-Label, Randomized, Parallel Group, Placebo-Controlled, Single-Center Study to Assess Anti-microbial Efficacy and Safety of DCN01 Compared to Unisol® Following Topical Periocular Administration in Healthy Volunteers
Description

This proof-of-concept study evaluates the clinical efficacy and safety of DCN01 in prepping of the periocular region.

UNKNOWN
Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading Dose
Description

The purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox.

COMPLETED
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte
Description

The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.

COMPLETED
Prevalence of SARS-CoV-2 in Conjunctival Swab Samples Among Patients With Conjunctivitis During the COVID-19 Pandemic
Description

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a newly identified, highly contagious RNA virus causing respiratory infectious disease, Coronavirus Disease 2019 (COVID-19). Conjunctivitis has been reported as a rare finding of the disease, and preliminary studies showed that the virus RNA could be detected in ocular secretions using polymerase chain reaction (PCR) assays when conjunctivitis present. This study aims to estimate the proportion of SARS-CoV-2 associated conjunctivitis among patients with suspected viral conjunctivitis presented to the ophthalmology clinics of Wilmer Eye Institute during the COVID-19 pandemic. The investigators also aim to identify whether SARS-CoV-2 associated conjunctivitis is an isolated finding or an early sign of COVID-19.

COMPLETED
The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo
Description

The purpose of this study is to determine if the addition of oral voriconazole to topical treatment regimens results in lower rates of perforation in severe fungal corneal ulcers.

COMPLETED
Mycotic Ulcer Treatment Trial I
Description

The purpose of this study is to determine if natamycin or voriconazole results in better visual outcomes in fungal corneal ulcers, especially visual acuity.

COMPLETED
Study of AzaSite Versus Vigamox Concentrations in the Conjunctiva and Aqueous Humor in Subjects Undergoing Routine Cataract Surgery
Description

The purpose of this study is to evaluate the drug concentrations in the conjunctiva and aqueous humor of AzaSite™ compared to Vigamox® in subjects undergoing routine cataract surgery

COMPLETED
Study of AzaSite Versus Vigamox in the Tears of Healthy Volunteers
Description

The purpose of this study is to evaluate the drug concentrations of AzaSite compared to Vigamox in tears of healthy volunteers

COMPLETED
Steroids for Corneal Ulcers Trial
Description

The purpose of this study is to determine whether adding topical steroids improves the outcomes of bacterial corneal ulcers, especially visual acuity.

RECRUITING
Efficacy of Fusidic Acid 1% in the Treatment of Bacterial Conjunctivitis
Description

The purpose of this clinical trial is to demonstrate the superiority of fusidic acid 1% over placebo in adults and children with confirmed bacterial conjunctivitis and to further establish the safety profile of fusidic acid 1% for topical ocular administration.

TERMINATED
Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis
Description

The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).

COMPLETED
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Vehicle for Bacterial Conjunctivitis (C-01-401-003)
Description

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 % AzaSite or Vehicle. Three visits will be required for this study.

COMPLETED
Evaluation of Clinical and Microbial Efficacy and Safety of AzaSite Compared to Tobramycin for Bacterial Conjunctivitis (C-01-401-004)
Description

The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to tobramycin for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye are eligible. Subjects will be randomly assigned to the AzaSite group or Tobramycin group. Three visits will be required for the study.

COMPLETED
Immune Responses to Antigens in Non-infectious Eye Inflammatory Diseases
Description

This study will collect blood samples from patients with non-infectious eye inflammatory diseases a spectrum of eye disorders that can produce sight-threatening vision loss. The blood will be analyzed for substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatments. Treatment is not offered under this protocol. Patients 6 years of age and older with an eye inflammatory disease, including non-infectious uveitis, ocular cicatricial pemphigoid, non-infectious scleritis, episcleritis, Stevens Johnson syndrome, Moorens ulcer, peripheral ulcerative keratitis and keratoconjunctivitis sicca, may be eligible for this study. Patients may or may not currently be participating in a treatment trial. Participants will have blood drawn through a needle in an arm vein. More samples may be collected if patients enrolled in another study are scheduled for additional visits. No more than 4 teaspoonfuls of blood will be collected at any one time.

Conditions
COMPLETED
Effect of Intensive Fly Control on Trachoma and Ocular Chlamydia Infection in Tanzania
Description

The purpose of this community-based randomized trial was to determine, in trachoma hyper-endemic communities of Tanzania, the added value of intensive spraying to control flies on the fly population and on trachoma and ocular chlamydia infection at 6 months and one year after mass antibiotic treatment.

Conditions
COMPLETED
Daclizumab to Treat Non-Infectious Sight-Threatening Uveitis
Description

This study will examine the safety and effectiveness of treating uveitis, an eye inflammation, with a monoclonal antibody called daclizumab. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. Daclizumab is designed to prevent a specific chemical interaction needed for immune cells called lymphocytes to produce inflammation. In an ongoing NIH study of 10 adults with uveitis, 8 patients were able to decrease corticosteroids and other immunosuppressive medicines they were taking while receiving daclizumab for months or even years. Seven patients continue to take the drug. Patients 18 years of age and older with active non-infectious intermediate or posterior uveitis in both eyes who require treatment for their disease may be eligible for this study. Candidates will be screened with the following tests and procedures: * Medical history and physical examination. * Eye examination to measure visual acuity and eye pressure, and examine the lens, retina, pupils and eye movements. * Blood tests to measure the number and types of blood cells. * Fluorescein angiography to check for abnormalities of eye blood vessels. A yellow dye injected into an arm vein travels to the blood vessels in the eyes. Pictures of the retina are taken with a special camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible abnormalities. Participants come to the NIH Clinical Center for treatment and follow-up visits. The first daclizumab treatment is given as a 90-minute infusion through a vein. A second IV infusion is given 7 days later. If the treatment has successfully reduced the eye inflammation after 2 weeks, then subsequent treatments are given through injections under the skin once a month for up to 1 year. Patients whose eye disease is not improved after 2 weeks stop the study treatments and receive alternative therapy. Follow-up visits are scheduled 7, 14, and 21 days after enrollment and at each treatment visit to evaluate the response to treatment and drug side effects. During these visits, patients repeat the exams done at screening. Extra blood samples are taken at certain visits to measure blood levels of daclizumab and to perform clinical laboratory and immunology tests. Fluorescein angiography is done at enrollment and after 1 year.

Conditions
COMPLETED
Daclizumab Injections to Treat Non-Infectious Sight-Threatening Uveitis
Description

This study will examine the safety and effectiveness of a monoclonal antibody called daclizumab in treating uveitis, an eye inflammation. Monoclonal antibodies are genetically engineered proteins made in large quantities and directed against a specific target in the body. Daclizumab is designed to prevent a specific chemical interaction needed for immune cells called lymphocytes to produce inflammation. In an ongoing NIH study of 10 adults with uveitis, 8 patients were able to decrease corticosteroids and other immunosuppressive medicines they were taking while receiving daclizumab for months or even years. The study will be conducted at three different sites, including the NIH Clinical Center. Patients 6 years of age and older with non-infectious uveitis of at least 3 months' duration who require treatment with immune suppressing medicines, such as prednisone, cyclophosphamide, cyclosporine, azathioprine, methotrexate, or others, may be eligible for this study. Candidates will be screened with a medical history and physical examination, blood tests, complete eye examination, and a questionnaire about the patient's vision and daily activities. Participants will come to the study center every 2 weeks for treatment and evaluation. Daclizumab treatments are given by injection under the skin, usually in the arm. Patients will receive a maximum of 28 treatments over a 1-year period. Treatment may be extended for a few months while other participants reach their 1-year mark. The first two induction treatments are at a higher dose (2 mg/kg of body weight) than the maintenance dose of 1 mg/kg. After the first daclizumab treatment, other uveitis medications will be tapered, one at a time. If the disease remains quiet, these drugs may eventually be stopped completely. For the first 6 months, all patients will receive daclizumab injections and evaluations every 2 weeks. After that, if other medications have been reduced and vision has remained stable, treatments and evaluations may be spread out to every 3 or 4 weeks. Over time, fewer tests may be required during the biweekly examinations if the patient is doing well, but nearly all the examinations done at screening will be repeated at 3-month intervals. If inflammation or vision loss occurs during drug tapering, appropriate treatment will be administered. If the vision loss is too great, the patient will be treated with steroids or other medicines and taken off the study. Additional, special tests done at selected study centers include the following: * Fluorescein angiography: This test is done to check for abnormalities of eye blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken with a special camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible abnormalities. * Pelvic ultrasound and urine test: These tests are done at enrollment and after 1 year to check the kidneys, lymph nodes, and pelvic area. * Blood tests: Additional blood tests are done at enrollment and every 3 to 6 months for laboratory and immunology study.

Conditions
COMPLETED
A Study of LX211 in Active Sight Threatening, Non-infectious Intermediate-, Anterior and Intermediate-, Posterior-, or Pan-Uveitis
Description

The objective of this study is to evaluate the safety and efficacy of LX211 as therapy in subjects with active non-infectious uveitis

COMPLETED
Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Non-Infectious Anterior Uveitis
Description

The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

COMPLETED
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Refractory Corneal Infection
Description

This study will evaluate the Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes with Corneal Infection. The treatment of UV-X system is to use the eyedrops of the riboflavin, also known as vitamin B2, and ultraviolet A (UVA) light. The eye drops are placed in affected eye and then affected cornea is exposed to UVA. UVA/riboflavin corneal collagen cross-linking was first used to treat patients in 1998 in Dresden, Germany. Data to date obtained mostly by physicians outside the United States has strongly suggested this treatment as an acceptable alternative, and many subjects have had a lasting effect (no progression) 3-5 years after their initial treatment.

Conditions
COMPLETED
Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment Uveitis
Description

The purpose of this study is to evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution EGP-437 using the EyeGate® II Drug Delivery System (EGDS) compared to prednisolone acetate ophthalmic suspension (1%) in patients with non-infectious anterior segment uveitis.

COMPLETED
Phase III Randomized Study of Oral Acyclovir in Infants With Herpes Simplex Virus Infection Limited to Skin, Eyes, and Mouth
Description

OBJECTIVES: I. Determine the efficacy of long term suppressive therapy with oral acyclovir in infants with herpes simplex virus infection limited to skin, eyes, and mouth. II. Determine the neurologic outcome in these patients when treated with this regimen. III. Evaluate the significance of a positive cerebrospinal fluid (CSF) polymerase chain reaction (PCR) result when all other CSF parameters remain normal in these patients. IV. Correlate the time to first positive CSF PCR result in the first 12 months of life with clinical neurological assessment in these patients when treated with this regimen. V. Determine whether the continuous administration of this drug suppresses recurrent skin lesions in these patients. VI. Determine the safety of this regimen in these patients.

Conditions
COMPLETED
Study of INV-102 Ophthalmic Solution in Adults With Acute Infectious Keratoconjunctivitis
Description

Phase 2, randomized study to assess topically administered eyedrops of INV-102 compared to vehicle during 1-week dosing in participants with Acute Infectious Keratoconjunctivitis (AIK). Participants will return for a follow up visit 1 week after end of treatment.

COMPLETED
A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis
Description

The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis .

ACTIVE_NOT_RECRUITING
Mindfulness Approach for Reducing Anxiety and Gloom in Ocular Inflammatory Diseases
Description

The proposed study is a block-randomized, controlled trial to evaluate the effects of a digital meditation and mindfulness practice on mental health in patients with non-infectious uveitis.

COMPLETED
The Efficacy Of SCH1 In The Treatment Of Acute Infectious Conjunctivitis
Description

The objective of this study is to evaluate the efficacy of Sasch1, a novel anti-infective eyedrop, in the treatment of acute infectious conjunctivitis.

RECRUITING
Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
Description

This is a multi-center randomized controlled evaluator-masked trial designed to compare metagenomic deep sequencing (MDS) versus standard of care testing for improvement of outcomes for intraocular infections. Patients with presumed intraocular infections who meet the eligibility criteria will be randomized to receive MDS testing results or not to receive MDS testing results. All patients will receive standard-of-care testing to guide management. Enrolled patients will be followed at week 2, week 3-6 (randomization visit), and at 4 weeks after the randomization visit. The proportions of patients who received the appropriate therapy and the proportions of patients with improved outcome will be compared between arms. Patient quality of life, MDS performance, and the provider certainly of belief will be collected.