A Phase 2 interventional study of LO2A and Placebo in Conjunctivochalasis, sponsored by Ocuwize LTD. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-27.
Sponsored by Ocuwize LTD · Phase 2, Interventional, and Treatment
A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Evaluate the Efficacy and Safety of LO2A Eye Drops in Patients with Moderate to Severe Conjunctivochalasis
Phase 2a, randomized, placebo-controlled, pilot study in up to 21 adult patients with moderate to severe CCh. Eligible patients will be randomly assigned in a 2:1 (active:placebo) ratio to one of two treatment groups, LO2A or placebo.
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).
Ocuwize LTD is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Moderate to severe conjunctivochalasis defined by:
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 who have used any of the following medications or treatments:
Sodium Hyaluronate
Drug: LO2A
Placebo
Drug: Placebo
The change from baseline in lissamine green conjunctival staining (LGCS) score
Time frame: baseline and 3 months
The change in the lid-parallel conjunctival fold (LIPCOF) grade score at 1 and 3 months compared to baseline
Time frame: baseline, 1 month and 3 months
The change from baseline in LGCS score
Time frame: baseline and 1 month
The change in tear-film break up time (TFBUT) compared to baseline at 1 and 3 months
Time frame: baseline, 1 month and 3 months]
The change in ocular surface disease index (OSDI) questionnaire score compared to baseline at 1 and 3 months
Time frame: baseline, 1 month and 3 months
Plan to share: Undecided — Final Data report will be publish when the study will be finalized
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Ocuwize LTD