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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. 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: NCT02852057
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : February 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.


Condition or disease Intervention/treatment Phase
Glaucoma Drug: timolol maleate and dorzolamide hydrochloride Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Timolol and Dorzolamide Loaded Contact Lenses
Actual Study Start Date : January 18, 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Glaucoma

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. At baseline visit IOP > 18 mm Hg and < 35 mm Hg, with difference between eyes of < 5 mm Hg
  2. Willingness to participate in washout period and to wear glasses if necessary
  3. Corneal thickness between 480 and 620 microns
  4. Shaffer Angle > 2
  5. Visual acuity of 20/200 or better
  6. Binocular
  7. Age 18 or over and willing and able to give consent

Exclusion Criteria:

  1. Pregnancy
  2. Asthma
  3. Bradycardia
  4. Steven's Johnson
  5. Sulpha drug intolerance
  6. Corneal ulcers or other corneal complications
  7. Dry eyes requiring two or more instillation of rewetting drops per day
  8. Any previous incidence of contact lens intolerance
  9. Highly aspheric cornea that would make fitting a contact lens difficult (i.e., keratoconus)
  10. Participation in any drug clinical trial in the last three months

Information from the National Library of Medicine

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


Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Shannon Hampton, BA    352-294-5016    sthistle@ufl.edu   
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Mark Sherwood University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02852057    
Other Study ID Numbers: IRB201602390
OCR19613 ( Other Identifier: University of Florida )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: February 15, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Dorzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Carbonic Anhydrase Inhibitors