Status:
COMPLETED
From Preserved, to Preservative-free Cyclosporine 0.1% Enhanced Triple Glaucoma Therapy
Lead Sponsor:
Aristotle University Of Thessaloniki
Conditions:
Glaucoma
Ocular Surface Disease
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
There is a lack of evidence on the impact of switching from a combined preserved anti-glaucoma regimen to a preservative-free (PF) one, while employing sufficiently robust OSD metrics. The investigato...
Detailed Description
Halting and reversing glaucoma therapy-related ocular surface disease (GTR-OSD) will improve the success of long-term medical therapy, impacting millions of patients worldwide. Chronic medical therapy...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Adult patients with well controlled open-angle glaucoma
- Patients chronically treated for more than 6 months with preserved, branded, or generic, triple antiglaucoma therapy comprising latanoprost and dorzolamide/timolol fixed combination
- Subjects should have experienced at least 1 symptom of dry eye (soreness, scratchiness, dryness, grittiness, and burning)
- Additionally, patients should demonstrate at least one of the objective signs for OSD at baseline: positive conjunctival staining with lissamine green and/or evidence of positive corneal staining with fluorescein (assessed with the 15-point Oxford scale),
- Patients must show a BUT\<8 seconds
- On screening patients should show a Schirmer test without anesthesia (Schirmer-I test) ≥3 and ≤10 mm in 5 minutes.
- When both eyes qualify the worse eye will be included in the study.
- Exclusion criteria
- Best corrected visual acuity \<1/10
- Patients with severe dry eye disease or Sjogren's disease
- Presence of eyelid abnormality, corneal disorder or abnormality, ocular surface metaplasia, filamentous keratitis, or corneal neovascularization
- Patients who have undergone ocular surgery (of any type, including laser surgery), or ocular trauma within 4 months prior to screening
- Subjects who had punctal occlusion, or diathermy within 3 months prior to screening or abnormality of the nasolacrimal drainage apparatus.
- Known allergy, or sensitivity to any of the study medications
- Uncontrolled systemic disease, or history or active signs of ocular trauma, infection, inflammation, allergic disease, or herpes; corneal ulcers; recurrent erosions; or uveitis
- Female patients will be excluded if they are pregnant, breastfeeding, planning a pregnancy, or are unwilling to use a reliable form of contraception.
Exclusion
Key Trial Info
Start Date :
May 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2020
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04673604
Start Date
May 6 2018
End Date
June 29 2020
Last Update
July 20 2022
Active Locations (1)
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1
University Department of Ophthalmology
Thessaloniki, Greece, 55536