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Pilocarpine and Brimonidine in Patients With Monofocal Lenses

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ClinicalTrials.gov Identifier: NCT03825081
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary

Brief Summary:
The current study aims to assess the use of pilocarpine and brimonidine to improve near visual acuity in patietns with monofocal intraocular lenses. Thirty-three subjects with be enrolled and baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.

Condition or disease Intervention/treatment Phase
Presbyopia Pseudophakia Drug: Brimonidine, pilocarpine Early Phase 1

Detailed Description:
This research study will try to find out if pilocarpine and brimonidine can help people with intraocular lens implants read without reading glasses. Thirty-three subjects will take part in this research study. Baseline visual acuity with be measured at near and distance. This will be compared to visual acuity after drop administration over 6 hours. A quality of life questionnaire will also be evaluated.All subjects will take part at Massachusetts Eye and Ear Infirmary (MEEI).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of Pilocarpine and Brimonidine to Improve Near Visual Acuity in Patients With Monofocal Intraocular Lenses
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention

Interventions will be the drugs:

  • pilocarpine - 0.5%
  • brimonidine - 0.2%

One drop of each of the study drugs will be placed in the non-dominant eye and patient will be evaluated for adverse events. At hour 1 and 3 vision will be measured for distance at 20 ft and reading at 14 inches; pupil size will be measured and patient will be evaluated for adverse events. At hour 6 vision will be measured for distance at 20 ft and reading at 14 inches; pupil size will be measured; patient will be evaluated for adverse events; and quality of life/satisfaction survey (NEI RQL-42) will be given to patient.

Drug: Brimonidine, pilocarpine

1 drop of pilocarpine (0.5%)

1 drop of brimonidine (0.2%)

Other Name: Mirvaso; Alphagan P; Salagen; Isopto Carpine




Primary Outcome Measures :
  1. Change in visual acuity after administration of pilocarpine and brimonidine [ Time Frame: baseline; hour 1 ]
    The primary aim of our study is to determine if the combination of pilocarpine and brimonidine improves near visual acuity in pseudophakic subjects 1 hour following drop placement, compared to baseline.


Secondary Outcome Measures :
  1. Change in near and distance visual acuity [ Time Frame: baseline; hours 1; 3; and 6 ]
    Near visual acuity at 3 hours and 6 hours, distance visual acuity at 1,3, and 6 hours.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study. Men and women between ages 60 years and above with monofocal intraocular lenses bilaterally corrected for distance and +/- 0.5D sphere vision who need only +/- 2.5 D correction for reading. Given the age group selected only post menopausal women will be evaluated.

Exclusion Criteria:

  • Individuals meeting any of the exclusion criteria at baseline will be excluded from study participation including: allergies to proparacaine, pilocarpine or brimonidine, eye infection or inflammation, glaucoma, retinal tear or retinal disease, eye surgery within the past 30 days, use of eye drops within the last seven days, participated in any other research study within the past 30 days. Patients using contact lenses.

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): NCT03825081


Contacts
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Contact: Matthew Gardiner, MD 617-573-3202 Matthew_Gardiner@meei.harvard.edu

Locations
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United States, Massachusetts
Massachusetts Eye and Ear Recruiting
Boston, Massachusetts, United States, 02114
Contact: Marisa Tieger, MD    941-323-9855    marisa_tieger@meei.harvard.edu   
Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Investigators
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Principal Investigator: Matthew Gardiner, MD Matthew_Gardiner@meei.harvard.edu

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Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT03825081     History of Changes
Other Study ID Numbers: 17-151H
First Posted: January 31, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
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
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Brimonidine Tartrate
Presbyopia
Pseudophakia
Refractive Errors
Eye Diseases
Signs and Symptoms
Pilocarpine
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents