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Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium (Pterygium)

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ClinicalTrials.gov Identifier: NCT03049852
Recruitment Status : Completed
First Posted : February 10, 2017
Results First Posted : February 12, 2020
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Cloudbreak Therapeutics, LLC

Brief Summary:

Stage 1: Single Ascending Dose, Safety, Tolerability and Pharmacokinetics (n=24)

Stage 2: Multiple Dose, Safety and Efficacy Study with 28-day Dosing and 5 months Followup (n=51)


Condition or disease Intervention/treatment Phase
Pterygium Drug: CBT-001 single dose Drug: Vehicle Drug: CBT-001 Multi-dose Phase 2

Detailed Description:

Stage 1: Single Ascending Dose, Safety, Tolerability and Pharmacokinetics (n=24)

Objectives are to evaluate ocular safety and tolerability by biomicroscopy, ophthalmoscopy, intraocular pressure and visual acuity, and to assess general safety by physical exams, vital signs, clinical laboratory tests and adverse events reporting and to evaluate systemic CBT-001 exposure by Cmax, Tmax and an estimation of the area under the curve (AUC).

Three dose cohorts will be planned with a dose ascending strategy to guide dose concentrations (n=8 per Cohort x 3 cohorts = 24). Primary pterygium patients will be selected in this phase because the main goal is to assess the safety and tolerability of CBT-001 and primary pterygium patients are much easier to recruit. The ~8 primary pterygium patients from each Cohort will be administered a single ocular drug dose at Day 1 in the eye with primary pterygium; the unaffected eye will be dosed with vehicle. Examinations will be performed at both screening day (Day 0) and Day 1. Blood samples at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours post dose will be taken at Day 1 to assess systemic pharmacokinetics (PK). The data will be reviewed by Data Review Committee (DRC) to determine whether to initiate enrollment for the next Cohort.

Cohort 1 will begin at the lowest CBT-001 concentration of 0.02%, followed by an increasing dose to 0.05% for Cohort 2 and then to 0.2% for Cohort 3. If no safety issues are found at all doses, the highest dose of 0.2% will be used for the next phase study.

Stage 2: Multiple Dose, Safety and Efficacy Study with 28-day Dosing and 5 months Followup (n=51)

Objectives are to evaluate ocular and systemic safety of CBT-001 in primary or recurrent patients that have moderate to severe pterygium vascularity and to assess whether CBT-001 is efficacious in reducing pterygium vascularity and pterygium lesion growth. The dosing will be 4 weeks. The followup period will be 5 months.

Study Population Characteristics: Approximately 50 (30 primary pterygium and 20 recurrent) patients will be enrolled at up to 3 centers to have an estimated 40 patients complete the study based on an anticipated dropout rate of 20%. Although we have no evidence to suggest attrition due to Adverse Effects (AEs), the dropout rate is most conservative based on industry experience in comparable clinical studies. Patients will be randomized in a 1:1 treatment allocation to receive either CBT-001 0.2% or Vehicle.

Dosage/Dose regimen: One drop of the assigned study medication will be administered in the study eye TID for 4 weeks. The study eye is defined as the qualified eye (i.e., the eye meeting the inclusion criterion for primary or recurrent pterygium). If both eyes are qualified, then the eye with the more severe vascularity grade on the Pterygium Hyperemia Grading Scale at the baseline (Day 1) visit will be the study eye. If both eyes meet the criterion and have the same severity, the right eye will be the study eye. Patients with bilateral pterygium will administer study medication only in the study eye. The fellow eyes in all study subjects will be untreated.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a Multicenter, Randomized, Vehicle-Controlled, Dose Escalating Study to Evaluate the Safety, Efficacy and Pharmacokinetics of CBT-001 Ophthalmic Solution in Patients With Primary or Recurrent Pterygium
Actual Study Start Date : April 15, 2017
Actual Primary Completion Date : April 30, 2018
Actual Study Completion Date : April 30, 2018

Arm Intervention/treatment
Experimental: CBT-001 Ophthalmic Solution Single dose
One drop in the study administered one time only for one day
Drug: CBT-001 single dose
One drop in the study administered one time

Placebo Comparator: Vehicle
One drop in the study administered three times daily (TID) for 4 weeks
Drug: Vehicle
One drop in the study administered three times daily (TID) for 4 weeks

Experimental: CBT-001 Ophthalmic Solution Multidose
One drop in the study administered three times daily (TID) for 4 weeks
Drug: CBT-001 Multi-dose
One drop in the study administered three times daily (TID) for 4 weeks




Primary Outcome Measures :
  1. Pterygium Vascularity Change Assessed Using the Pterygium Hyperemia Grading Scale [ Time Frame: Change from baseline at 4 weeks ]
    The primary efficacy variable is the change from baseline (Day 1) in severity grade of pterygium vascularity at Week 4. Pterygium vascularity intensity is based on color coordinates as measured by digital image analysis of pterygium photographs. The quantitative analysis of photographs using a 5-point Pterygium Hyperemia Grading Scale (0 = absent, 1 = trace, 2 = mild, 3 = moderate, 4 = severe) will be conducted at an independent image reading center.

  2. Ocular and General Safety and Tolerability [ Time Frame: One day ]
    The ocular safety and tolerability are measured by biomicroscopy, ophthalmoscopy, intraocular pressure and visual acuity, and to assess general safety by physical exams, vital signs, clinical laboratory tests and adverse events reporting


Secondary Outcome Measures :
  1. Corneal Pterygium Lesion Length Change From Baseline [ Time Frame: 4 weeks ]
    The Corneal Pterygium Lesion Length is measured from digital images of the eye by an independent image reading center.



Information from the National Library of Medicine

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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:

  • Primary pterygium with moderate vascularity (Pterygium Hyperemia Grading Scale ≥ 3)

Exclusion Criteria:

  • Active ocular disease, corneal abnormalities other than pterygium, active ocular infection, or any ocular pathology unrelated to pterygium in either eye that could affect the assessment of the pterygium
  • History of ocular herpes disease in either eye
  • Any ocular surgical procedure within the last 3 months
  • Female patients who are pregnant, nursing, or planning a pregnancy during the study

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): NCT03049852


Locations
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United States, California
Harvard Eye Associates
Laguna Beach, California, United States, 92651
Sponsors and Collaborators
Cloudbreak Therapeutics, LLC
Investigators
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Principal Investigator: John Hovanesian, M.D. Harvard Eye Associates
  Study Documents (Full-Text)

Documents provided by Cloudbreak Therapeutics, LLC:

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Responsible Party: Cloudbreak Therapeutics, LLC
ClinicalTrials.gov Identifier: NCT03049852    
Other Study ID Numbers: CBT-CS101
First Posted: February 10, 2017    Key Record Dates
Results First Posted: February 12, 2020
Last Update Posted: February 24, 2020
Last Verified: September 2018
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
Additional relevant MeSH terms:
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Pterygium
Conjunctival Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions