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

Sponsor
ForSight Vision5, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02742649
Collaborator
(none)
55
Enrollment
1
Location
3
Arms
8
Actual Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1/Phase 2

Study Design

Study Type:
Interventional
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 :
Apr 30, 2016
Actual Primary Completion Date :
Dec 31, 2016
Actual Study Completion Date :
Dec 31, 2016

Arms and Interventions

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 Names:
  • 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 Names:
  • 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 Names:
  • Timolol component only

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

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

    Outcome Measures

    Primary Outcome Measures

    1. Intraocular Pressure (IOP) on Day 8 [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 [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 [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinica de Ojos Orillac - Calvo Panama City Panama

    Sponsors and Collaborators

    • ForSight Vision5, Inc.

    Investigators

    • Study Director: Michelle Chen, PhD, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ForSight Vision5, Inc.
    ClinicalTrials.gov Identifier:
    NCT02742649
    Other Study ID Numbers:
    • FSV5-FC-001
    First Posted:
    Apr 19, 2016
    Last Update Posted:
    Feb 25, 2019
    Last Verified:
    Feb 1, 2019
    Additional relevant MeSH terms:
    Glaucoma
    Glaucoma, Open-Angle
    Ocular Hypertension
    Hypertension
    Timolol
    Bimatoprost

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Washout + Placebo Ocular Insert Fixed Combination (FC) Ocular Insert Bimatoprost Ocular Insert Timolol Ocular Insert Timolol 0.5% Ophthalmic Drops
    Arm/Group Description During the washout period, participants wore a placebo insert in each eye serving as a trial-wear period for 24 to 48 days. Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following a second washout period, timolol drops, 0.5% solution twice daily in each eye from Day 99 to 112.
    Period Title: Pre-Randomization Washout Period
    STARTED 55 0 0 0 0
    COMPLETED 50 0 0 0 0
    NOT COMPLETED 5 0 0 0 0
    Period Title: Pre-Randomization Washout Period
    STARTED 0 17 17 16 0
    COMPLETED 0 16 17 16 0
    NOT COMPLETED 0 1 0 0 0
    Period Title: Pre-Randomization Washout Period
    STARTED 0 0 0 0 49
    COMPLETED 0 0 0 0 48
    NOT COMPLETED 0 0 0 0 1

    Baseline Characteristics

    Arm/Group Title Fixed Combination (FC) Ocular Inset Bimatoprost Ocular Insert Timolol Ocular Insert Total
    Arm/Group Description Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. Total of all reporting groups
    Overall Participants 17 17 16 50
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    67.24
    (12.94)
    68.94
    (5.75)
    67.56
    (9.27)
    67.92
    (9.61)
    Sex: Female, Male (Count of Participants)
    Female
    14
    82.4%
    11
    64.7%
    11
    68.8%
    36
    72%
    Male
    3
    17.6%
    6
    35.3%
    5
    31.3%
    14
    28%
    Intraocular Pressure (IOP) (mm Hg) [Mean (Standard Deviation) ]
    Randomization (T=0 hour)
    24.34
    (2.06)
    24.30
    (1.89)
    24.18
    (1.78)
    24.27
    (1.88)
    Randomization (T=4 hour)
    22.98
    (2.92)
    22.93
    (3.06)
    23.33
    (2.77)
    23.07
    (2.87)
    Randomization (T=8 hour)
    22.44
    (2.57)
    22.90
    (3.13)
    23.03
    (2.70)
    22.78
    (2.77)

    Outcome Measures

    1. Primary Outcome
    Title Intraocular Pressure (IOP) on Day 8
    Description 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.
    Time Frame Day 8

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period).
    Arm/Group Title Fixed Combination (FC) Ocular Insert Bimatoprost Ocular Insert Timolol Ocular Insert
    Arm/Group Description Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98.
    Measure Participants 17 17 16
    Day 8 (T=0 hour)
    17.83
    (3.39)
    19.15
    (2.62)
    19.59
    (4.68)
    Day 8 (T=4 hour)
    17.51
    (3.18)
    18.96
    (4.14)
    19.88
    (5.42)
    Day 8 (T=8 hour)
    17.05
    (3.32)
    17.84
    (4.00)
    19.66
    (4.54)
    2. Primary Outcome
    Title IOP on Day 16
    Description 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.
    Time Frame Day 16

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period). Number analyzed is the number of participants with data at the given time-point.
    Arm/Group Title Fixed Combination (FC) Ocular Insert Bimatoprost Ocular Insert Timolol Ocular Insert
    Arm/Group Description Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98.
    Measure Participants 15 17 16
    Day 16 (T=0 hour)
    18.29
    (3.86)
    18.08
    (3.98)
    20.81
    (5.22)
    Day 16 (T=4 hour)
    17.95
    (3.10)
    18.64
    (4.17)
    21.08
    (5.46)
    Day 16 (T=8 hour)
    17.21
    (4.14)
    18.54
    (3.73)
    19.43
    (3.77)
    3. Primary Outcome
    Title IOP on Day 28
    Description 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.
    Time Frame Day 28

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period). Number analyzed is the number of participants with data at the given time-point.
    Arm/Group Title Fixed Combination (FC) Ocular Insert Bimatoprost Ocular Insert Timolol Ocular Insert
    Arm/Group Description Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98.
    Measure Participants 16 17 16
    Day 28 (T=0 hour)
    18.03
    (4.21)
    18.44
    (4.23)
    19.75
    (4.80)
    Day 28 (T=4 hour)
    18.54
    (3.50)
    19.59
    (3.70)
    20.09
    (4.67)
    Day 28 (T=8 hour)
    17.26
    (2.60)
    18.77
    (4.13)
    19.20
    (3.60)
    4. Primary Outcome
    Title IOP on Day 49
    Description 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.
    Time Frame Day 49

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period). Number analyzed is the number of participants with data at the given time-point.
    Arm/Group Title Fixed Combination (FC) Ocular Insert Bimatoprost Ocular Insert Timolol Ocular Insert
    Arm/Group Description Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98.
    Measure Participants 15 17 16
    Day 49 (T=0 hour)
    18.55
    (4.05)
    18.88
    (4.52)
    18.63
    (3.89)
    Day 49 (T=4 hour)
    17.77
    (4.02)
    19.35
    (3.51)
    19.67
    (3.54)
    Day 49 (T=8 hour)
    17.23
    (4.53)
    18.48
    (3.57)
    19.13
    (2.40)
    5. Primary Outcome
    Title IOP on Day 70
    Description 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.
    Time Frame Day 70

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period). Number analyzed is the number of participants with data at the given time-point.
    Arm/Group Title Fixed Combination (FC) Ocular Insert Bimatoprost Ocular Insert Timolol Ocular Insert
    Arm/Group Description Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
    Measure Participants 16 17 16
    Day 70 (T=0 hour)
    17.60
    (2.94)
    17.78
    (2.58)
    17.79
    (4.36)
    Day 70 (T=4 hour)
    18.09
    (3.73)
    18.71
    (3.59)
    18.48
    (4.23)
    Day 70 (T=8 hour)
    17.14
    (2.64)
    18.61
    (4.07)
    18.78
    (4.13)
    6. Secondary Outcome
    Title Number of Participants With Ocular and Non-Ocular Adverse Events
    Description 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.
    Time Frame From Randomization (Day 0) to Day 70

    Outcome Measure Data

    Analysis Population Description
    Safety population set included all randomized participants who had an ocular insert placed at the Randomization Visit. In this analysis set, participants were analyzed according to the treatment received during each study treatment period.
    Arm/Group Title Fixed Combination (FC) Ocular Insert Bimatoprost Ocular Insert Timolol Ocular Insert
    Arm/Group Description Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98.
    Measure Participants 17 17 16
    Ocular
    13
    76.5%
    14
    82.4%
    10
    62.5%
    Non-Ocular
    11
    64.7%
    10
    58.8%
    5
    31.3%
    7. Secondary Outcome
    Title IOP During Open Label Period
    Description 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.
    Time Frame Day 98, Day 112

    Outcome Measure Data

    Analysis Population Description
    FAS included all participants who were randomized, treated and returned for at least one (1) regularly scheduled post-treatment visit. Participants were analyzed in the treatment group to which they were randomized (Double Blind Treatment Period). Number analyzed is the number of participants with data at the given time-point.
    Arm/Group Title Fixed Combination (FC) Ocular Insert Bimatoprost Ocular Insert Timolol Ocular Insert
    Arm/Group Description Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98.
    Measure Participants 17 17 16
    Day 98 (T=0 hour)
    22.61
    (2.41)
    22.69
    (3.06)
    23.24
    (3.54)
    Day 98 (T=4 hour)
    21.67
    (2.42)
    22.38
    (3.16)
    22.99
    (4.25)
    Day 98 (T=8 hour)
    20.74
    (1.65)
    22.88
    (3.89)
    22.63
    (3.92)
    Day 112 (T=0 hour)
    19.21
    (3.59)
    20.65
    (3.90)
    19.71
    (1.59)
    Day 112 (T=4 hour)
    17.62
    (3.41)
    18.52
    (3.97)
    18.75
    (4.26)
    Day 112 (T=8 hour)
    17.51
    (3.98)
    18.43
    (4.45)
    18.19
    (3.69)

    Adverse Events

    Time Frame Randomization (Day 0) to the end of the study (Day 112)
    Adverse Event Reporting Description
    Arm/Group Title Fixed Combination (FC) Ocular Inset Bimatoprost Ocular Insert Timolol Ocular Insert
    Arm/Group Description Following washout period, one segment of bimatoprost and one segment of timolol maleate were combined in an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. Following washout period, one segment of bimatoprost and one placebo segment were combined in an ocular ring and inserted in each eye for 70 days followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112. Following washout period, one segment of timolol and one placebo segment were combined into an ocular ring and inserted in each eye for 70 days, followed by a second washout period from Day 71 to 98. Following the second washout period, 0.5% timolol drops twice daily in each eye from Day 99 to 112.
    All Cause Mortality
    Fixed Combination (FC) Ocular Inset Bimatoprost Ocular Insert Timolol Ocular Insert
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/17 (0%) 0/17 (0%) 0/16 (0%)
    Serious Adverse Events
    Fixed Combination (FC) Ocular Inset Bimatoprost Ocular Insert Timolol Ocular Insert
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/17 (11.8%) 1/17 (5.9%) 0/16 (0%)
    Cardiac disorders
    Mitral valve incompetence 1/17 (5.9%) 0/17 (0%) 0/16 (0%)
    Injury, poisoning and procedural complications
    Upper limb fracture 0/17 (0%) 1/17 (5.9%) 0/16 (0%)
    Surgical and medical procedures
    Knee arthroplasty 1/17 (5.9%) 0/17 (0%) 0/16 (0%)
    Other (Not Including Serious) Adverse Events
    Fixed Combination (FC) Ocular Inset Bimatoprost Ocular Insert Timolol Ocular Insert
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 16/17 (94.1%) 16/17 (94.1%) 11/16 (68.8%)
    Ear and labyrinth disorders
    Vertigo 0/17 (0%) 0/17 (0%) 1/16 (6.3%)
    Eye disorders
    Eye discharge 5/17 (29.4%) 5/17 (29.4%) 5/16 (31.3%)
    Conjunctival disorder 4/17 (23.5%) 2/17 (11.8%) 5/16 (31.3%)
    Eye irritation 5/17 (29.4%) 4/17 (23.5%) 2/16 (12.5%)
    Conjunctival hyperaemia 5/17 (29.4%) 2/17 (11.8%) 1/16 (6.3%)
    Ocular discomfort 4/17 (23.5%) 3/17 (17.6%) 1/16 (6.3%)
    Conjunctivitis 3/17 (17.6%) 1/17 (5.9%) 2/16 (12.5%)
    Punctate Keratitis 3/17 (17.6%) 1/17 (5.9%) 1/16 (6.3%)
    Vision Blurred 2/17 (11.8%) 2/17 (11.8%) 2/16 (12.5%)
    Eyelid Oedema 0/17 (0%) 2/17 (11.8%) 1/16 (6.3%)
    Keratitis 2/17 (11.8%) 1/17 (5.9%) 1/16 (6.3%)
    Foreign body sensation in eyes 1/17 (5.9%) 1/17 (5.9%) 0/16 (0%)
    Lacrimation increased 1/17 (5.9%) 0/17 (0%) 1/16 (6.3%)
    Dry eye 0/17 (0%) 1/17 (5.9%) 0/16 (0%)
    Erythema of eyelid 0/17 (0%) 0/17 (0%) 1/16 (6.3%)
    Lagophthalmos 1/17 (5.9%) 0/17 (0%) 0/16 (0%)
    Photophobia 1/17 (5.9%) 0/17 (0%) 0/16 (0%)
    Retinal artery occlusion 0/17 (0%) 1/17 (5.9%) 0/16 (0%)
    Gastrointestinal disorders
    Diarrhoea 0/17 (0%) 1/17 (5.9%) 0/16 (0%)
    Gastritis 1/17 (5.9%) 0/17 (0%) 0/16 (0%)
    Hepatobiliary disorders
    Hepatic steatosis 1/17 (5.9%) 0/17 (0%) 0/16 (0%)
    Infections and infestations
    Upper respiratory tract infection 7/17 (41.2%) 7/17 (41.2%) 2/16 (12.5%)
    Conjunctivitis viral 1/17 (5.9%) 1/17 (5.9%) 1/16 (6.3%)
    Urinary tract infection 0/17 (0%) 1/17 (5.9%) 1/16 (6.3%)
    Erysipelas 0/17 (0%) 1/17 (5.9%) 0/16 (0%)
    Infected skin ulcer 0/17 (0%) 1/17 (5.9%) 0/16 (0%)
    Injury, poisoning and procedural complications
    Ligament sprain 1/17 (5.9%) 0/17 (0%) 0/16 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 1/17 (5.9%) 0/17 (0%) 2/16 (12.5%)
    Back pain 2/17 (11.8%) 0/17 (0%) 0/16 (0%)
    Nervous system disorders
    Headache 3/17 (17.6%) 1/17 (5.9%) 1/16 (6.3%)
    Dizziness 1/17 (5.9%) 0/17 (0%) 0/16 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus 1/17 (5.9%) 4/17 (23.5%) 0/16 (0%)
    Alopecia 0/17 (0%) 1/17 (5.9%) 0/16 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    No presentation or publication of Institution's data relating to the Trial may occur until after the Trial has been completed at all sites. If Investigator desires to present or publish, investigator must submit any and all manuscripts, posters, abstracts, or other intended publications (hereinafter collectively referred to as "manuscripts") to Sponsor at least sixty (60) days prior to the actual submission of such manuscript(s) for publication.

    Results Point of Contact

    Name/Title Therapeutic Area Head,
    Organization Allergan, Inc
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    ForSight Vision5, Inc.
    ClinicalTrials.gov Identifier:
    NCT02742649
    Other Study ID Numbers:
    • FSV5-FC-001
    First Posted:
    Apr 19, 2016
    Last Update Posted:
    Feb 25, 2019
    Last Verified:
    Feb 1, 2019