Effectiveness and Safety of Timolol and Dorzolamide Loaded Contact Lenses

• Status: Recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Florida
• Treatments: Dorzolamide; Maleic acid; Timolol

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