Clinical trial NCT04891588: Switching From the Preserved to the Preservative - Free Latanoprost - Timolol FC in Glaucoma Patients With OSD
Official title: Evaluation of Glaucoma or Ocular Hypertension Patients With Pre-existing Ocular Surface Disease Switched From a Preserved Prostaglandin Analog - Timolol Fixed Combination to a Preservative - Free Latanoprost - Timolol Fixed Combination
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Open-angle Glaucoma
Ocular Hypertension
Keywords: glaucoma
ocular surface disease
preservative
treatment
Prostaglandin/timolol fixed combination
tolerability
Lead sponsor: Klinički Bolnički Centar Zagreb
Sponsor class: OTHER
Collaborators: name: University of Zagreb
First posted: 2021-05-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of drug tolerability
timeFrame: through study completion, an average of 6 months
measure: Change of symptoms of ocular surface disease
timeFrame: through study completion, an average of 6 months
measure: Change of visual function
timeFrame: through study completion, an average of 6 months
measure: Change of signs of ocular surface disease
timeFrame: through study completion, an average of 6 months
measure: Change of tear film stability
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Evaluation of the effectiveness of preservative-free latanoprost / timolol FC in terms of changing intraocular pressure values
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Klinički bolnički centar Zagreb
Study officials:
affiliation: Klinički Bolnički Centar Zagreb
name: Sonja Jandroković, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xing Y, Zhu L, Zhang K, Huang S. The efficacy of the fixed combination of latanoprost and timolol versus other fixed combinations for primary open-angle glaucoma and ocular hypertension: A systematic review and meta-analysis. PLoS One. 2020 Feb 27;15(2):e0229682. doi: 10.1371/journal.pone.0229682. eCollection 2020.
citation: Uusitalo H, Chen E, Pfeiffer N, Brignole-Baudouin F, Kaarniranta K, Leino M, Puska P, Palmgren E, Hamacher T, Hofmann G, Petzold G, Richter U, Riedel T, Winter M, Ropo A. Switching from a preserved to a preservative-free prostaglandin preparation in topical glaucoma medication. Acta Ophthalmol. 2010 May;88(3):329-36. doi: 10.1111/j.1755-3768.2010.01907.x.
citation: Misiuk-Hojlo M, Pomorska M, Mulak M, Rekas M, Wierzbowska J, Prost M, Wasyluk J, Lubinski W, Podboraczynska-Jodko K, Romaniuk W, Kinasz R, Ortyl-Markiewicz R, Mocko L, Zaleska-Zmijewska A, Rokicki D, Baudouin C. The RELIEF study: Tolerability and efficacy of preservative-free latanoprost in the treatment of glaucoma or ocular hypertension. Eur J Ophthalmol. 2019 Mar;29(2):210-215. doi: 10.1177/1120672118785280. Epub 2018 Jul 12.
citation: Guven Yilmaz S, Degirmenci C, Karakoyun YE, Yusifov E, Ates H. The efficacy and safety of bimatoprost/timolol maleate, latanoprost/timolol maleate, and travoprost/timolol maleate fixed combinations on 24-h IOP. Int Ophthalmol. 2018 Aug;38(4):1425-1431. doi: 10.1007/s10792-017-0601-8. Epub 2017 Jun 14.