Pilocarpine and Brimonidine in Patients With Monofocal Lenses

NCT03825081 | Unknown Early Phase 1 FDA Drug

• 1 other identifier: 17-151H
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbyopia; Pseudophakia

Outcome Measures

Primary Outcomes (1)

• Change in visual acuity after administration of pilocarpine and brimonidine

  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.

  baseline; hour 1

Secondary Outcomes (1)

• Change in near and distance visual acuity

  baseline; hours 1; 3; and 6

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

Brimonidine, pilocarpine DRUG

1 drop of pilocarpine (0.5%) 1 drop of brimonidine (0.2%)

Also known as: Mirvaso; Alphagan P; Salagen; Isopto Carpine

Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Presbyopia; Pseudophakia

Interventions

Brimonidine Tartrate; Pilocarpine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Alkaloids

Study Officials

• Matthew Gardiner, MD

  Matthew_Gardiner@meei.harvard.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Gardiner, MD

CONTACT

617-573-3202; Matthew_Gardiner@meei.harvard.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 31, 2019
• Study Start: January 21, 2019
• Primary Completion: September 1, 2019
• Study Completion: December 31, 2019
• Last Updated: January 31, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)