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Trial record 15 of 274 for:    Panama

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

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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.

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.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Fixed Combination Drug: Bimatoprost Drug: Timolol Device: Placebo Segment Drug: Timolol 0.5% Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : April 30, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016


Arm Intervention/treatment
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.
Drug: Fixed Combination
Continuous elution from the ocular insert.
Other Name: Bimatoprost-Timolol combination

Device: Placebo Segment
One segment of placebo (no drug product)

Drug: Timolol 0.5%
0.5% timolol drops twice daily.

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.
Drug: Bimatoprost
Continuous elution from the ocular insert. This is an active control arm.
Other Name: Bimatoprost component only

Device: Placebo Segment
One segment of placebo (no drug product)

Drug: Timolol 0.5%
0.5% timolol drops twice daily.

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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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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

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

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): NCT02742649


Locations
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Panama
Clinica de Ojos Orillac - Calvo
Panama City, Panama
Sponsors and Collaborators
ForSight Vision5, Inc.
Investigators
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Study Director: Michelle Chen, PhD Allergan

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Responsible Party: ForSight Vision5, Inc.
ClinicalTrials.gov Identifier: NCT02742649     History of Changes
Other Study ID Numbers: FSV5-FC-001
First Posted: April 19, 2016    Key Record Dates
Results First Posted: December 31, 2018
Last Update Posted: February 25, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Timolol
Bimatoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents