Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients With Moderate to Severe Conjunctivochalasis
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|ClinicalTrials.gov Identifier: NCT02804191|
Recruitment Status : Unknown
Verified September 2017 by Ocuwize LTD.
Recruitment status was: Recruiting
First Posted : June 17, 2016
Last Update Posted : September 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Conjunctivochalasis||Drug: LO2A Drug: Saline||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
eye drop solution.
Placebo Comparator: Placebo-Controlled
- The change from baseline in lissamine green conjunctival staining (LGCS) score. [ Time Frame: 3 Months ]
- The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline [ Time Frame: 3 Months ]
- The change from baseline in LGCS score [ Time Frame: 1 month ]
- The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months [ Time Frame: 3 Months ]
- The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months [ Time Frame: 3 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804191
|Contact: Adam Foley-Comer, MD||054 749 1753 ext +email@example.com|
|Contact: Sergeu Socae, M.D firstname.lastname@example.org|
|Contact: Meital email@example.com|
|Contact: Avi Solomon, M.D firstname.lastname@example.org|
|Ichilov Tel Aviv hospital||Recruiting|
|Tel Aviv, Israel|
|Contact: David Varssano, M.D 972-5242663000 'email@example.com'|
|Contact: Keren Elia Ogalbo 972-36974165|
|Study Director:||Or Eisenberg, CPA||Ocuwize Pharma|