Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis
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|ClinicalTrials.gov Identifier: NCT03845374|
Recruitment Status : Completed
First Posted : February 19, 2019
Last Update Posted : November 30, 2021
This study is a prospective, randomized, open-label, two arms, clinical study aim to evaluate the efficacy and safety of treatment with Hyper-CL™ lens + Antibiotics compared with treatment with Antibiotics only, in subjects with Bacterial keratitis.
The design of the Hyper-CL™ lens increases contact time of the antibiotics on the cornea enabling increased bioavailability of the active drug.
|Condition or disease||Intervention/treatment||Phase|
|Bacterial Keratitis||Device: Hyper-CL™ lens||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
40 patients will be randomized to one of the following 2 groups:
|Masking:||None (Open Label)|
|Official Title:||Prospective, Randomized Multi-Center Study of Using the Hyper-CL™ Lens in Subjects Suffering From Bacterial Keratitis|
|Actual Study Start Date :||March 13, 2019|
|Actual Primary Completion Date :||December 22, 2020|
|Actual Study Completion Date :||January 11, 2021|
Experimental: Conventional Antibiotics+ Hyper-CL™ lens
Conventional treatment with topical Antibiotics+ Hyper-CL™ lens
Device: Hyper-CL™ lens
Use of the Hyper-CL™
No Intervention: Conventional Antibiotics
Conventional treatment with topical Antibiotics
- Change in Bacterial Keratitis severity score [ Time Frame: From date of randomization up to 14 days ]Will be measured by Bacterial keratitis severity score (0-5). A low score is considered an improvement, a high score is considered worsening.
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): NCT03845374
|Rambam Medical Center|
|Haifa, Israel, 3109601|
|Sheba Medical Center|
|Ramat Gan, Israel, 52621|