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Study of LL-BMT1 in Patients With Elevated Intraocular Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04747808
Recruitment Status : Completed
First Posted : February 10, 2021
Results First Posted : May 10, 2022
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
MediPrint Ophthalmics, Inc.

Study Description
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Brief Summary:
This is an open-label, Phase 2a clinical study of LL-BMT1 in patients with primary open-angle glaucoma and ocular hypertension. Study subjects will be treated for 7 days with a single dose of LL-BMT1.

Condition or disease Intervention/treatment Phase
Primary Open Angle Glaucoma Ocular Hypertension Drug: LL-BMT1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open-label, non-comparative
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2a Study of Safety, Tolerability, and Efficacy of Drug-Delivering Contact Lens LL-BMT1 in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Actual Study Start Date : January 8, 2021
Actual Primary Completion Date : February 16, 2021
Actual Study Completion Date : February 16, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: LL-BMT1
Group 4 extended-wear contact lens printed with bimatoprost
 Drug: LL-BMT1
Drug-printed contact lens in both eyes


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Event Rate [ Time Frame: Day 7 ]
    Number of subjects with adverse events


Secondary Outcome Measures :
  1. Intraocular Pressure Elevation [ Time Frame: Day 7 ]
    Number of subjects with IOP elevation >= 5 mm Hg in study eye

  2. IOP Changes [ Time Frame: Days 1 ]
    Mean change in IOP from baseline in study eye (mm Hg) on Day 1, 4 pm


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, at least 18 years of age at the Screening Visit
  • Diagnosed with primary open-angle glaucoma or ocular hypertension in both eyes
  • At least one eye (called the study eye) must have an untreated intraocular pressure between 22 mmHg and 34 mmHg (inclusive) as measured at 9 am during the Baseline Visit.
  • Best corrected visual acuity of Early Treatment Diabetic Retinopathy Study of 50 letters or better

Exclusion Criteria:

  • Glaucoma or optic neuropathy due to anything other than above noted reasons Cup-to-disc ratio of >0.8 in either eye
  • Corneal thickness <480 or >620 μm
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04747808


Locations
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United States, California
Eye Research Foundatoin
Newport Beach, California, United States, 92663
Sponsors and Collaborators
MediPrint Ophthalmics, Inc.
  Study Documents (Full-Text)

Documents provided by MediPrint Ophthalmics, Inc.:
Study Protocol  [PDF] December 21, 2020
Statistical Analysis Plan  [PDF] February 11, 2021

More Information
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Responsible Party: MediPrint Ophthalmics, Inc.
ClinicalTrials.gov Identifier: NCT04747808    
Other Study ID Numbers: LL-BMT10001
First Posted: February 10, 2021    Key Record Dates
Results First Posted: May 10, 2022
Last Update Posted: June 8, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MediPrint Ophthalmics, Inc.:
Glaucoma
Prostaglandin
Intraocular pressure
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
 Vascular Diseases
Cardiovascular Diseases
Eye Diseases