Pilocarpine and Brimonidine in Patients With Monofocal Lenses

Early Phase 1

• Conditions: Pseudophakia; Presbyopia
• Interventions: Drug: Brimonidine, pilocarpine

• Registration Number: NCT03825081
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2019-01
• Study Start: 2019-01-21
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-30
• Last Update Submitted: 2019-01-30
• Study First Posted: 2019-01-31
• Last Update Posted: 2019-01-31
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Brimonidine, pilocarpine	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Massachusetts Eye and Ear; 🇺🇸 Boston, Massachusetts, United States