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)

Enrollment

Location

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 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).

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

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 Names: Mirvaso; Alphagan P; Salagen; Isopto Carpine

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 Names:

Mirvaso; Alphagan P; Salagen; Isopto Carpine

Outcome Measures

Primary Outcome Measures

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

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

	Site	City	State	Country	Postal Code
1	Massachusetts Eye and Ear	Boston	Massachusetts	United States	02114

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:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 31, 2019