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A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression leading to optic nerve damage. An increase indicates worsening. Only one eye contributed to the analysis. LLOQ is defined as 0. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information.
Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : November 24, Last Update Posted : July 2, View this study on Beta.
Study Description. The purpose of this study is to evaluate the efficacy of LME compared to vehicle in the reduction of ocular symptoms and to evaluate the safety and tolerability of LME, when administered topically for up to 42 days, in subjects with severe dry eye disease.
Detailed Description:. This study is organized into 2 phases. Following a 2-week identification phase, eligible subjects with severe dry eye disease DED will be randomized into the treatment phase and will be dispensed study treatment for 10 weeks. FDA Resources. Arms and Interventions. Outcome Measures. Visual Acuity VA with the subject's best spectacles or other visual corrective devices was measured using an ETDRS visual acuity chart at 3 meters 10 feet and reported in letters read correctly.
IOP fluid pressure inside the eye was assessed using Goldmann applanation tonometry or Tonopen and measured in millimeters of mercury mmHg. The dilated fundus examination was performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve. Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method.
Samples were collected and assessed for anti-LME antibodies. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Inclusion Criteria: Must sign written informed consent. Unwilling to abstain from topical ocular non-prescription medications during the course of the study, including concomitant use of artificial tears, gels, lubricants, re-wetting drops, allergy drops, etc.
Use of nasal, inhaled, systemic including injections , or topical corticosteroids within 30 days of Visit 1. Women of child-bearing potential unwilling to use effective contraception methods as defined in the protocol. Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Sponsor Alcon, a Novartis Company Industry. Overall Status Completed. Ages Eligible for Study:. Responsible Party:. Studies a U. FDA-regulated Drug Product:. Keywords provided by Alcon, a Novartis Company. Time Frame Baseline Day 43 , Day 71 Outcome Measure Data Analysis Population Description This analysis population includes all randomized subjects with at least a post-baseline primary endpoint assessment excluding all subjects who met the critical deviation criteria Per-Protocol Set.
Number Analyzed is the number of subjects with data at visit. Dry Eye. Of the enrolled, subjects entered the vehicle run-in period and entered the randomized treatment period. This analysis population includes all randomized subjects with at least a post-baseline primary endpoint assessment excluding all subjects who met the critical deviation criteria Per-Protocol Set.
This analysis population includes all subjects that received any study drug Safety Analysis Set. This analysis population includes all subjects with available pharmacokinetics data Pharmacokinetics Analysis Set. This analysis population includes all subjects with available immunogenicity data Immunogenicity Analysis Set.
Adverse events AEs were collected from time of informed consent for the duration of a subject's participation in the study up to 85 days.
An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. Reports of AEs were obtained through solicited and spontaneous comments from the subjects and through observations by the Investigator as outlined in the study protocol. All subjects exposed to LME Vehicle prior to the initiation of randomized study treatment.
All subjects exposed to LME ophthalmic solution during randomized study treatment.
WebJun 17, · Alcon, the global leader in eye care, is delighted that the British Contact Lens Association has awarded members of our Research and Development team . Web Complements Alcon generated research Is aligned with the Alcon product scientific/development strategy, and Will enhance understanding of the risk/benefit profile of a product or could help to address an unmet medical need. Resources The Investigator must have the right infrastructure in place with capability to complete the study. WebJan 4, · The compound, named LME , is based on a proprietary single-chain antibody fragment technology specifically designed for topical delivery. Efficacy and .