Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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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

Conditions
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Conjunctivochalasis

Intervention / Treatment
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* Drug: LO2A
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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: LIPCOF score ≥ 2; and Lissamine green conjunctival staining score ≥ 5 according to National Eye Institute/Industry Workshop report. 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: Subject has been diagnosed or treated for another malignancy within 3 years of screening, except in situ malignancy, or low-risk prostate, skin or cervix cancer after curative therapy. A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications. 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: LASIK or PRK surgery within 12 months of Visit 1. Use of contact lenses within 7 days of Visit 1. Punctal plug insertion within 30 days of Visit 1. Use of topical or systemic cyclosporine within 30 days of Visit 1. Use of medications known to cause ocular drying (e.g. antihistamines, sleep aids, etc.), unless at a stable dose, within 30 days of Visit 1. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LO2A<br>Sodium Hyaluronate | Drug: LO2A<br>* eye drop solution.<br>|
| Placebo Comparator: Placebo-Controlled<br>Saline. | Drug: Saline<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in lissamine green conjunctival staining (LGCS) score. |  | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline |  | 3 Months | 
| The change from baseline in LGCS score |  | 1 month | 
| The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months |  | 3 Months | 
| The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months |  | 3 Months |