Pilocarpine and Brimonidine in Patients With Monofocal Lenses
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03825081|
Recruitment Status : Recruiting
First Posted : January 31, 2019
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Presbyopia Pseudophakia||Drug: Brimonidine, pilocarpine||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness of Pilocarpine and Brimonidine to Improve Near Visual Acuity in Patients With Monofocal Intraocular Lenses|
|Actual Study Start Date :||January 21, 2019|
|Estimated Primary Completion Date :||September 1, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Interventions will be the drugs:
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 Name: Mirvaso; Alphagan P; Salagen; Isopto Carpine
- Change in visual acuity after administration of pilocarpine and brimonidine [ Time Frame: 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.
- Change in near and distance visual acuity [ Time Frame: baseline; hours 1; 3; and 6 ]Near visual acuity at 3 hours and 6 hours, distance visual acuity at 1,3, and 6 hours.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03825081
|Contact: Matthew Gardiner, MD||617-573-3202||Matthew_Gardiner@meei.harvard.edu|
|United States, Massachusetts|
|Massachusetts Eye and Ear||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Marisa Tieger, MD 941-323-9855 email@example.com|
|Principal Investigator:||Matthew Gardiner, MD||Matthew_Gardiner@meei.harvard.edu|