Status:
UNKNOWN
Switching From the Preserved to the Preservative - Free Latanoprost - Timolol FC in Glaucoma Patients With OSD
Lead Sponsor:
Klinički Bolnički Centar Zagreb
Collaborating Sponsors:
University of Zagreb
Conditions:
Primary Open-angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Glaucoma is a group of chronic eye diseases that are characterized by a progressive optic nerve damage and consequent visual loss. In most cases, it is associated with elevated intraocular pressure. I...
Detailed Description
Glaucoma is a heterogeneous group of chronic ocular diseases characterized by a loss of the retinal nerve fiber layer and consequent damage to the optic nerve head. Increased intraocular pressure is c...
Eligibility Criteria
Inclusion
- patients with open angle galucoma or ocular hypertension that had been controlled (stable IOP \<19mmHg) by commercially available preserved PGA -timolol FC for at least 3 months
- Stable visual field (based on at least two reliable visual field tests performed within the last 12 months)
- Central corneal thickness within the range 500-580µm.
- mild to moderate hyperaemia based on MacMonnies (scores 1 and 2)
Exclusion
- Best-corrected visual acuity (BCVA) 0,1 or lower
- Severe visual field defects (MD 12 dB or higher)
- Any intraocular surgery (other than filtration surgery performed at least 6 months before screening)
- Any ocular surface abnormality preventing accurate IOP measurement
- Acute ocular inflammation
- Contact lens wearers
Key Trial Info
Start Date :
March 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 8 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04891588
Start Date
March 8 2021
End Date
December 8 2021
Last Update
May 18 2021
Active Locations (1)
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1
Klinički bolnički centar Zagreb
Zagreb, Croatia, 10000