Effectiveness and Safety of Timolol and Dorzolamide Loaded Contact Lenses
2 other identifiers
interventional
2
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jan 2018
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2016
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedStudy Start
First participant enrolled
January 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 10, 2021
CompletedDecember 2, 2021
December 1, 2021
3.6 years
July 28, 2016
December 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
IOP
Pressure will be measured in trial subjects before placement of lenses and after day 1, day 2, day 4, day 7, and day 9
Day 1, Day 2, Day 4, Day 7, and Day 9
Study Arms (1)
Subjects Receiving Lenses
EXPERIMENTALAll subjects who meet inclusion criteria will receive lenses loaded with timolol maleate and dorzolamide hydrochloride.
Interventions
Timolol maleate and dorzolamide hydrochloride loaded contact lenses
Eligibility Criteria
You may qualify if:
- At baseline visit IOP \> 18 mm Hg and \< 35 mm Hg, with difference between eyes of \< 5 mm Hg
- Willingness to participate in washout period and to wear glasses if necessary
- Corneal thickness between 480 and 620 microns
- Shaffer Angle \> 2
- Visual acuity of 20/200 or better
- Binocular
- Age 18 or over and willing and able to give consent
You may not qualify if:
- Pregnancy
- Asthma
- Bradycardia
- Steven's Johnson
- Sulpha drug intolerance
- Corneal ulcers or other corneal complications
- Dry eyes requiring two or more instillation of rewetting drops per day
- Any previous incidence of contact lens intolerance
- Highly aspheric cornea that would make fitting a contact lens difficult (i.e., keratoconus)
- Participation in any drug clinical trial in the last three months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Sherwood
University of Florida
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2016
First Posted
August 2, 2016
Study Start
January 18, 2018
Primary Completion
August 10, 2021
Study Completion
August 10, 2021
Last Updated
December 2, 2021
Record last verified: 2021-12