Phase
Condition
N/ATreatment
CSB-001 Ophthalmic Solution 0.1%
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Centrally or paracentrally located scar approximately ≤5 mm and ≥2 mm in thegreatest diameter and with a portion of the scar within approximately 3.5 mm of theoptical center of the cornea assessed at Screening and confirmed at Baseline, andsubject reports ability to detect any effect of scar on any element of vision.
Eye with a recent corneal insult approximately ≤30 days and ≥7 days from theScreening Visit.
Corneal insult includes but is not limited to mechanical / chemical / thermalinjury, bacterial keratitis, PRK, and contact lens related ulcer.
Eye with observed rate of epithelialization that in the investigator's opinion doesnot demonstrate clinical characteristics of a slow healing (persistent defect)cornea.
Subjects must have the ability and willingness to comply with study procedures.
Exclusion
Exclusion Criteria:
Corneal scar that encompasses more than approximately 50% of the depth of theremaining stroma as guided by ASOCT image at the Screening Visit.
Maximum scar diameter greater than approximately 5 mm without prior approval by theSponsor based on Screening Visit images.
No portion of the scar is within the approximate 3.5 mm of the optical center of thecornea based on Screening Visit images.
Any active ocular infection in the opinion of the investigator (bacterial, viral,fungal, or protozoal) at the Screening or Day 1 Visits. Subjects with an activebacterial infection at the Screening or Day 1 Visit in the opinion of theinvestigator may be rescheduled to reassess the status of the infection and continuein the study if infection is deemed not active.
Ocular surgery planned during the study treatment period.
Presence or history of any ocular or systemic disorder, condition or procedure thatmight hinder the efficacy of the study treatment or its evaluation, could possiblyinterfere with the interpretation of study results, or could be judged by theinvestigator to be incompatible with the study visit schedule or conduct.
Note: Other inclusion/exclusion criteria apply.
Study Design
Connect with a study center
Loma Linda University Eye Institute
Loma Linda, California 92354
United StatesActive - Recruiting
Midwest Cornea Associates, LLC
Carmel, Indiana 46290
United StatesActive - Recruiting
Francis Price Jr, MD
Indianapolis, Indiana 46260
United StatesActive - Recruiting
Minnesota Eye Consultants
Minnetonka, Minnesota 55305
United StatesActive - Recruiting
Legacy Devers Eye Institute
Portland, Oregon 97210
United StatesActive - Recruiting
Stuart A. Terry, MD PA
San Antonio, Texas 78212
United StatesActive - Recruiting
Virginia Eye Consultants
Norfolk, Virginia 23502
United StatesActive - Recruiting
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