Ocular Hypertension, Primary Open-angle Glaucoma
Conditions
Keywords
glaucoma, ocular surface disease, preservative, treatment, Prostaglandin/timolol fixed combination, tolerability
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. If glaucoma left untreated, complete blindness can occur. Prostaglandin analog- timolol FCs are common glaucoma therapy because these drugs have been shown to effectively lower intraocular pressure (IOP). It is also known that chronic use of preservatives in the drops leads to ocular surface disease (OSD) which can lead to low tolerability of prescribed drops and gaps in the dosing regimen. The purpose of this study is to investigate whether drug preservative elimination results in reduction of OSD symptoms and signs as well as improvement of latanoprost-timolol FC local tolerability in the treatment of glaucoma and ocular hypertension. In this trial, on each visit (V1, V2 and V3) following tests will be used: Snellen visual acuity, IOP measurement by Goldman applanation tonometry, OSD signs assessment on the slit lamp (corneal and conjunctival fluorescein surface staining, conjunctival hyperemia and tear film stability assessment using Tear Break- up Time test - TBUT). Visual Analog Scale (VAS) will be used for a subjective assessment of drug tolerability. The association of quality of life and dry eye symptoms in participants will be measured by the Ocular Surface Disease Index (OSDI) questionnaire.
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 considered a major risk factor for development of the disease. If glaucoma left untreated, visual field impairment and complete visual loss can occur. Due to the effective reduction of intraocular pressure, prostaglandin analog-timolol fixed combinations (FC) are considered to be a mainstay in glaucoma treatment. However, it is well known that long-term use of preservatives in glaucoma drops leads to ocular surface disease (OSD) which causes low tolerability and nonadherence with prescribed therapy. The study is designed to determine whether switching from a preserved prostaglandin analog- timolol FC to an equally effective and safe preservative - free latanoprost - timolol FC can result in alleviation or elimination of OSD and improvement of local tolerability. In this study, on each visit (V1, V2 and V3) following tests will be performed: Snellen visual acuity, IOP measurement by Goldman applanation tonometry, OSD signs assessment on the slit lamp (fluorescein corneal and conjunctival fluorescein surface staining, conjunctival hyperemia and tear film stability assessment using Tear Break- up Time test -TBUT). The subjective evaluation of drug tolerability will be quantified by Visual Analog Scale (VAS). The evaluation of the association of quality of life and dry eye symptoms in respondents will be examined with the Ocular Surface Disease Index (OSDI) questionnaire.
Interventions
DRUGSwitching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC)
switching preserved prostaglandin analog- timolol FC (fixed combination) in the period of three months in patients with ocular hypertension and open angle glaucoma who exhibit ocular surface disease (OSD) signs and symptoms to an equally effective and safe preservative - free (PF) latanoprost - timolol FC (Fixalpost). form: preservative free latanoprost - timolol fix combination (50 micrograms/ml latanoprost + 5 mg/ml timolol), ocular solution dosage: once daily, at 8.00 p.m. duration: 3 months
Sponsors
University of Zagreb
Klinički Bolnički Centar Zagreb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of drug tolerability | through study completion, an average of 6 months | In this study, the following test is carried out at every visit (V1, V 2 and V3) every month to determine the change of drug tolerability: The Visual Analog Scale is used to determine drug tolerability. |
| Change of symptoms of ocular surface disease | through study completion, an average of 6 months | In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to determine the change of symptoms of ocular surface disease: The subjects' symptoms of ocular surface disease is assessed using a standardized questionnaire - Ocular Surface Disease Index - OSDI questionnaire. |
| Change of visual function | through study completion, an average of 6 months | In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to evaluate change of visual function: Visual Acuity Testing (Snellen Chart). |
| Change of signs of ocular surface disease | through study completion, an average of 6 months | In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to determine the change of symptoms of ocular surface disease: Slit lamp examination (fluorescein staining of the cornea and conjunctiva, hyperemia of the conjunctiva) |
| Change of tear film stability | through study completion, an average of 6 months | In this study, the following tests is carried out at every visit (V1, V 2 and V3) every month to evaluate change of signs of ocular surface disease: assessment of the tear film stability by measuring the tear film break-up time (TBUT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the effectiveness of preservative-free latanoprost / timolol FC in terms of changing intraocular pressure values | through study completion, an average of 6 months | In this study, applanation tonometry according to Goldmann will be performed at every visit (V1, V 2 and V3) every month to measure intraocular pressure in mmHg. |
Countries
Croatia
Contacts
Primary ContactSonja Jandroković, MD PhD
Backup ContactSania Vidas Pauk, MD PhD
Outcome results
None listed