Pilocarpine and Brimonidine in Patients With Monofocal Lenses

Sponsor
Massachusetts Eye and Ear Infirmary (Other)
Overall Status
Unknown status
CT.gov ID
NCT03825081
Collaborator
(none)
33
Enrollment
1
Location
1
Arm
11.3
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
33 participants
Allocation:
N/A
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 :
Jan 21, 2019
Anticipated Primary Completion Date :
Sep 1, 2019
Anticipated Study Completion Date :
Dec 31, 2019

Arms and Interventions

ArmIntervention/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 Names:
  • Mirvaso; Alphagan P; Salagen; Isopto Carpine
  • Outcome Measures

    Primary Outcome Measures

    1. Change in visual acuity after administration of pilocarpine and brimonidine [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 [baseline; hours 1; 3; and 6]

      Near visual acuity at 3 hours and 6 hours, distance visual acuity at 1,3, and 6 hours.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Massachusetts Eye and EarBostonMassachusettsUnited States02114

    Sponsors and Collaborators

    • Massachusetts Eye and Ear Infirmary

    Investigators

    • Principal Investigator: Matthew Gardiner, MD, Matthew_Gardiner@meei.harvard.edu

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Massachusetts Eye and Ear Infirmary
    ClinicalTrials.gov Identifier:
    NCT03825081
    Other Study ID Numbers:
    • 17-151H
    First Posted:
    Jan 31, 2019
    Last Update Posted:
    Jan 31, 2019
    Last Verified:
    Jan 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:

    Study Results

    No Results Posted as of Jan 31, 2019