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Trial record 15 of 283 for:    Panama

A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension

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: NCT02742649
Recruitment Status : Completed
First Posted : April 19, 2016
Results First Posted : December 31, 2018
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
ForSight Vision5, Inc.

Tracking Information
First Submitted Date  ICMJE April 6, 2016
First Posted Date  ICMJE April 19, 2016
Results First Submitted Date  ICMJE June 8, 2018
Results First Posted Date  ICMJE December 31, 2018
Last Update Posted Date February 25, 2019
Actual Study Start Date  ICMJE April 30, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • Intraocular Pressure (IOP) on Day 8 [ Time Frame: Day 8 ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
  • IOP on Day 16 [ Time Frame: Day 16 ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
  • IOP on Day 28 [ Time Frame: Day 28 ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
  • IOP on Day 49 [ Time Frame: Day 49 ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
  • IOP on Day 70 [ Time Frame: Day 70 ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour). The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
Reduction in Intraocular Pressure (IOP) [ Time Frame: 10 weeks ]
Change History Complete list of historical versions of study NCT02742649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • Number of Participants With Ocular and Non-Ocular Adverse Events [ Time Frame: From Randomization (Day 0) to Day 70 ]
    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. Reported here is the number of participants with adverse events related to the eye as well as number of participants with all other adverse events.
  • IOP During Open Label Period [ Time Frame: Day 98, Day 112 ]
    IOP is a measurement of the fluid pressure inside the eye. IOP was measured at the following three time points: 8 am (T=0 hour), 12 pm (T=4 hour) and 4 pm (T=8 hour) at the start (Day 98) and end (Day 112) of the Open Label Period during which participants were treated with timolol 0.5% ophthalmic solution twice daily. The IOP measured in the two eyes was averaged to compute a single IOP value for each timepoint.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
Safety of the Ocular Insert by regular ocular exams [ Time Frame: 10 weeks ]
regular ocular exams to assess safety of the Ocular Inserts
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Efficacy and Safety of a Fixed Combination Ocular Insert in Participants With Open-angle Glaucoma or Ocular Hypertension
Official Title  ICMJE A Phase 1B, Multicenter, Randomized, Double-masked, Controlled Study to Evaluate the Efficacy and Safety of a Fixed Combination Bimatoprost/Timolol Ocular Insert Compared to Its Individual Components With Crossover to Timolol 0.5% in Subjects With Open-angle Glaucoma (OAG) or Ocular Hypertension (OHT)
Brief Summary The purpose of this study is to determine if a combination of two drugs (bimatoprost and timolol) delivered to the surface of the eye over 10 weeks is better at lowering intraocular pressure (IOP) than either of the drugs delivered alone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Open-Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE
  • Drug: Fixed Combination
    Continuous elution from the ocular insert.
    Other Name: Bimatoprost-Timolol combination
  • Drug: Bimatoprost
    Continuous elution from the ocular insert. This is an active control arm.
    Other Name: Bimatoprost component only
  • Drug: Timolol
    Continuous elution from the ocular insert. This is an active control arm.
    Other Name: Timolol component only
  • Device: Placebo Segment
    One segment of placebo (no drug product)
  • Drug: Timolol 0.5%
    0.5% timolol drops twice daily.
Study Arms  ICMJE
  • Experimental: Fixed Combination (FC) Ocular Insert
    Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one segment of timolol maleate combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
    Interventions:
    • Drug: Fixed Combination
    • Device: Placebo Segment
    • Drug: Timolol 0.5%
  • Experimental: Bimatoprost Ocular Insert
    Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of bimatoprost and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
    Interventions:
    • Drug: Bimatoprost
    • Device: Placebo Segment
    • Drug: Timolol 0.5%
  • Experimental: Timolol Ocular Insert
    Washout plus Placebo Ocular Insert in each eye for 24 to 48 days, followed by one segment of timolol and one placebo segment (no drug product) combined onto a single ocular insert in each eye for 70 days. Following a second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
    Interventions:
    • Drug: Timolol
    • Device: Placebo Segment
    • Drug: Timolol 0.5%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 7, 2019)
55
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2016)
88
Actual Study Completion Date  ICMJE December 31, 2016
Actual Primary Completion Date December 31, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Written informed consent
  • At least 18 years of age
  • Diagnosis in both eyes of either primary open-angle glaucoma (POAG) or ocular hypertension
  • Best corrected-distance visual acuity score equivalent to 20/80 or better
  • Stable visual field
  • Central corneal thickness between 490 - 620 micrometers

Inclusion Criteria at the Randomization Visit:

  • IOP for each eye is ≥ 23 mmHg at T=0hr, ≥ 20 mmHg at T=4hr and T=8hr.
  • Inter-eye IOP difference of ≤ 5.0 mmHg at T=0hr, T=4hr and T=8hr.
  • IOP for each eye is ≤ 30 mmHg at T=0hr, T=4hr and T=8hr.

Key Exclusion Criteria:

  • Any known contraindication to prostaglandin analog (latanoprost, travoprost, bimatoprost, tafluprost) or timolol
  • A cardiac or pulmonary condition that in the opinion of the Investigator would contraindicate the use of a topical beta-blocker
  • Use of any agents known to have a substantial effect on IOP during planned study period (e.g. beta-blockers)
  • Cup-to-disc ratio of greater than 0.8
  • Significant risk of angle closure due to pupil dilation, defined as a Shaffer classification of less than Grade 2 based on gonioscopy
  • Ocular, orbital, and/or eyelid surgery of any type within the past six (6) months from screening date
  • Laser surgery for glaucoma / ocular hypertension on one (1) or both eyes within the last six (6) months
  • Past history of any incisional surgery for glaucoma at any time
  • Past history of corneal refractive surgery
  • Corneal abnormalities that would interfere with accurate IOP readings with an applanation tonometer
  • Current participation in an investigational drug or device study or participation in such a study within 7 days of Screening
  • Inability to adequately evaluate the retina
  • Subjects who will require contact lens use during the study period.
  • Subjects who currently have punctal occlusion
  • Pregnant, lactating or of child-bearing potential and not using a medically acceptable form of birth control
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02742649
Other Study ID Numbers  ICMJE FSV5-FC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party ForSight Vision5, Inc.
Study Sponsor  ICMJE ForSight Vision5, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Michelle Chen, PhD Allergan
PRS Account ForSight Vision5, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP