Effectiveness and Safety of Timolol and Dorzolamide Loaded Contact 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02852057|
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : December 2, 2021
This study focuses on glaucoma therapy by drug eluting contact lenses. The contact lens will be loaded with timolol maleate and dorzolamide hydrochloride, both of which are commonly used ophthalmic drugs. Additionally, the lenses will contain vitamin E ((+) α-tocopherol) as an additive for achieving extended release of the drugs.
This study is to assess the safety of the drug loaded contact lenses and the effectiveness. Effectiveness will be a drop in IOP after using the lenses.
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Drug: timolol maleate and dorzolamide hydrochloride||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness and Safety of Timolol and Dorzolamide Loaded Contact Lenses|
|Actual Study Start Date :||January 18, 2018|
|Actual Primary Completion Date :||August 10, 2021|
|Actual Study Completion Date :||August 10, 2021|
Experimental: Subjects Receiving Lenses
All subjects who meet inclusion criteria will receive lenses loaded with timolol maleate and dorzolamide hydrochloride.
Drug: timolol maleate and dorzolamide hydrochloride
Timolol maleate and dorzolamide hydrochloride loaded contact lenses
Other Name: Cosopt PF
- IOP [ Time Frame: Day 1, Day 2, Day 4, Day 7, and Day 9 ]Pressure will be measured in trial subjects before placement of lenses and after day 1, day 2, day 4, day 7, and day 9
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): NCT02852057
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Mark Sherwood||University of Florida|