Recruiting
Early Phase 1

Pilocarpine & Brimonidine

Sponsor:

Massachusetts Eye and Ear Infirmary

Code:

NCT03825081

Conditions

Presbyopia

Pseudophakia

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

Interventions

Brimonidine, pilocarpine

Study Details

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

Study ID

NCT03825081

Start date

Jan 21, 2019

Status verified date

Jan, 2019

Completion date

Dec 31, 2019

Anticipated

Primary completion date

Sep 1, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Accepted

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

Enrollment

33 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Brimonidine, pilocarpine

1 drop of pilocarpine (0.5%)

1 drop of brimonidine (0.2%)

Primary outcome measure

  • Change in visual acuity after administration of pilocarpine and brimonidine [ Time Frame: baseline; hour 1 ]

Central Contacts and Locations

Central contacts

Matthew Gardiner, MD

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

Locations

Massachusetts Eye and Ear

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Marisa Tieger, MD

941-323-9855marisa_tieger@meei.harvard.edu

More Information

Sponsor

Massachusetts Eye and Ear Infirmary

Last update posted

Jan 31, 2019

Last verified

Jan, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts Eye and Ear Infirmary on 2019-01-31.