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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis
Full description
Phase 2, randomized, placebo-controlled, parallel group, study in up to 62 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 1:1 ratio to one of two treatment groups, LO2A or placebo, stratified by LIPCOF grade at baseline.
This study with 4 visits, will consist of a screening period of up to 2 weeks and a 3-month treatment period (topical, OU, QID application of eye drops).
Enrollment
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Inclusion criteria
Male or female of any race and ≥ 18 years of age.
Willing and able to provide voluntary written informed consent.
Moderate to severe conjunctivochalasis defined by:
Willing and able to adhere to the study visit schedule and other protocol requirements.
Exclusion criteria
Subject has concurrent, uncontrolled medical condition, or psychiatric illness which could place him/her at unacceptable risk, including, but not limited to:
Subjects with pterygium.
Subjects with active, allergic keratoconjunctivitis, or conjunctivitis of infectious origin.
Subjects with blepharitis requiring treatment.
Subjects with a history of surgery affecting the eye surface, as well as eye injuries within 3 months of screening.
Subjects currently using any topical ophthalmic treatment (including medications for glaucoma) or over-the-counter (OTC) solutions, artificial tears, gels or scrubs, and cannot discontinue these medications for the duration of the trial.
Subjects who have used any of the following medications or treatments:
Known hypersensitivity to sodium hyaluronate or any LO2A excipients (glycerol and Carbomer 981).
Active abuse of alcohol or drugs.
Any condition, which in the opinion of the Investigator, would place the patient at an unacceptable risk if participating in the study protocol.
Participation in a clinical trial of an investigational (unapproved) drug or device within 1 month prior to screening or scheduled to receive another investigational drug or device during this study
Primary purpose
Allocation
Interventional model
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62 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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