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Trial record 15 of 277 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.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Open-Angle Glaucoma
Ocular Hypertension
Interventions Drug: Fixed Combination
Drug: Bimatoprost
Drug: Timolol
Device: Placebo Segment
Drug: Timolol 0.5%
Enrollment 55
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Washout + Placebo Ocular Insert Fixed Combination (FC) Ocular Insert Bimatoprost Ocular Insert Timolol Ocular Insert Timolol 0.5% Ophthalmic Drops
Hide 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
Reason Not Completed
Washout/Randomization Failure             5             0             0             0             0
Period Title: Double-Blind Treatment Period
Started 0 17 17 16 0
Completed 0 16 17 16 0
Not Completed 0 1 0 0 0
Reason Not Completed
Adverse Event             0             1             0             0             0
Period Title: Open-Label Period
Started 0 0 0 0 49
Completed 0 0 0 0 48
Not Completed 0 0 0 0 1
Reason Not Completed
Lost to Follow-up             0             0             0             0             1
Arm/Group Title Fixed Combination (FC) Ocular Inset Bimatoprost Ocular Insert Timolol Ocular Insert Total
Hide 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 Number of Baseline Participants 17 17 16 50
Hide Baseline Analysis Population Description
Full analysis set (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).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 17 participants 16 participants 50 participants
67.24  (12.94) 68.94  (5.75) 67.56  (9.27) 67.92  (9.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 17 participants 16 participants 50 participants
Female
14
  82.4%
11
  64.7%
11
  68.8%
36
  72.0%
Male
3
  17.6%
6
  35.3%
5
  31.3%
14
  28.0%
Intraocular Pressure (IOP)   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 17 participants 17 participants 16 participants 50 participants
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)
[1]
Measure 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.
1.Primary Outcome
Title Intraocular Pressure (IOP) on Day 8
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 17 17 16
Mean (Standard Deviation)
Unit of Measure: mm Hg
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 15 17 16
Mean (Standard Deviation)
Unit of Measure: mm Hg
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 16 17 16
Mean (Standard Deviation)
Unit of Measure: mm Hg
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 15 17 16
Mean (Standard Deviation)
Unit of Measure: mm Hg
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 16 17 16
Mean (Standard Deviation)
Unit of Measure: mm Hg
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 17 17 16
Measure Type: Count of Participants
Unit of Measure: Participants
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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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.
Overall Number of Participants Analyzed 17 17 16
Mean (Standard Deviation)
Unit of Measure: mm Hg
Day 98 (T=0 hour) Number Analyzed 16 participants 17 participants 16 participants
22.61  (2.41) 22.69  (3.06) 23.24  (3.54)
Day 98 (T=4 hour) Number Analyzed 16 participants 17 participants 16 participants
21.67  (2.42) 22.38  (3.16) 22.99  (4.25)
Day 98 (T=8 hour) Number Analyzed 16 participants 17 participants 16 participants
20.74  (1.65) 22.88  (3.89) 22.63  (3.92)
Day 112 (T=0 hour) Number Analyzed 16 participants 17 participants 15 participants
19.21  (3.59) 20.65  (3.90) 19.71  (1.59)
Day 112 (T=4 hour) Number Analyzed 16 participants 17 participants 15 participants
17.62  (3.41) 18.52  (3.97) 18.75  (4.26)
Day 112 (T=8 hour) Number Analyzed 16 participants 17 participants 15 participants
17.51  (3.98) 18.43  (4.45) 18.19  (3.69)
Time Frame Randomization (Day 0) to the end of the study (Day 112)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fixed Combination (FC) Ocular Inset Bimatoprost Ocular Insert Timolol Ocular Insert
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%)   0/16 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Fixed Combination (FC) Ocular Inset Bimatoprost Ocular Insert Timolol Ocular Insert
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/17 (11.76%)   1/17 (5.88%)   0/16 (0.00%) 
Cardiac disorders       
Mitral valve incompetence   1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Injury, poisoning and procedural complications       
Upper limb fracture   0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Surgical and medical procedures       
Knee arthroplasty  [1]  1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
[1]
This was a planned procedure.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fixed Combination (FC) Ocular Inset Bimatoprost Ocular Insert Timolol Ocular Insert
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/17 (94.12%)   16/17 (94.12%)   11/16 (68.75%) 
Ear and labyrinth disorders       
Vertigo   0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Eye disorders       
Eye discharge   5/17 (29.41%)  5/17 (29.41%)  5/16 (31.25%) 
Conjunctival disorder   4/17 (23.53%)  2/17 (11.76%)  5/16 (31.25%) 
Eye irritation   5/17 (29.41%)  4/17 (23.53%)  2/16 (12.50%) 
Conjunctival hyperaemia   5/17 (29.41%)  2/17 (11.76%)  1/16 (6.25%) 
Ocular discomfort   4/17 (23.53%)  3/17 (17.65%)  1/16 (6.25%) 
Conjunctivitis   3/17 (17.65%)  1/17 (5.88%)  2/16 (12.50%) 
Punctate Keratitis   3/17 (17.65%)  1/17 (5.88%)  1/16 (6.25%) 
Vision Blurred   2/17 (11.76%)  2/17 (11.76%)  2/16 (12.50%) 
Eyelid Oedema   0/17 (0.00%)  2/17 (11.76%)  1/16 (6.25%) 
Keratitis   2/17 (11.76%)  1/17 (5.88%)  1/16 (6.25%) 
Foreign body sensation in eyes   1/17 (5.88%)  1/17 (5.88%)  0/16 (0.00%) 
Lacrimation increased   1/17 (5.88%)  0/17 (0.00%)  1/16 (6.25%) 
Dry eye   0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Erythema of eyelid   0/17 (0.00%)  0/17 (0.00%)  1/16 (6.25%) 
Lagophthalmos   1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Photophobia   1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Retinal artery occlusion   0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Gastrointestinal disorders       
Diarrhoea   0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Gastritis   1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Hepatobiliary disorders       
Hepatic steatosis   1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Infections and infestations       
Upper respiratory tract infection   7/17 (41.18%)  7/17 (41.18%)  2/16 (12.50%) 
Conjunctivitis viral   1/17 (5.88%)  1/17 (5.88%)  1/16 (6.25%) 
Urinary tract infection   0/17 (0.00%)  1/17 (5.88%)  1/16 (6.25%) 
Erysipelas   0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Infected skin ulcer   0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Injury, poisoning and procedural complications       
Ligament sprain   1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Musculoskeletal and connective tissue disorders       
Arthralgia   1/17 (5.88%)  0/17 (0.00%)  2/16 (12.50%) 
Back pain   2/17 (11.76%)  0/17 (0.00%)  0/16 (0.00%) 
Nervous system disorders       
Headache   3/17 (17.65%)  1/17 (5.88%)  1/16 (6.25%) 
Dizziness   1/17 (5.88%)  0/17 (0.00%)  0/16 (0.00%) 
Skin and subcutaneous tissue disorders       
Pruritus   1/17 (5.88%)  4/17 (23.53%)  0/16 (0.00%) 
Alopecia   0/17 (0.00%)  1/17 (5.88%)  0/16 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Responsible Party: ForSight Vision5, Inc.
ClinicalTrials.gov Identifier: NCT02742649     History of Changes
Other Study ID Numbers: FSV5-FC-001
First Submitted: April 6, 2016
First Posted: April 19, 2016
Results First Submitted: June 8, 2018
Results First Posted: December 31, 2018
Last Update Posted: February 25, 2019