Switching From the Preserved to the Preservative - Free Latanoprost - Timolol FC in Glaucoma Patients With OSD

NCT ID: NCT04891588

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2021-12-08

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.

Conditions

Primary Open-angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Switching the preserved to preservative free prostaglandin analog-timolol FC

To switch preserved prostaglandin analog- timolol FC (Fixapost 50 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container) 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 in order to investigate whether that can result in alleviation or elimination of OSD and improvement of local tolerability.

Group Type: EXPERIMENTAL

Switching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC)

Intervention Type: DRUG

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

Interventions

Switching 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

Intervention Type: DRUG

Other Intervention Names

Fixalpost ( T2347), 50 micrograms/ml latanoprost + 5 mg/ml timolol maleate eye drops, solution in single-dose container

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Zagreb

OTHER

Sponsor Role: collaborator

Klinički Bolnički Centar Zagreb

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sonja Jandroković, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Klinički Bolnički Centar Zagreb

Locations

Klinički bolnički centar Zagreb

Zagreb, , Croatia

Site Status: RECRUITING

Countries

Croatia

Central Contacts

Sonja Jandroković, MD PhD

Role: CONTACT

sonja.jandrokovic@gmail.com

+385 (01) 238 8430

Sania Vidas Pauk, MD PhD

Role: CONTACT

sania_vidas@yahoo.com

+385 (01) 238 8430

Facility Contacts

Kristina Mikina

Role: primary

predstojnik.oci@kbc-zagreb.hr

00385-01-2388430

Varja Ivković

Role: backup

varja.ivkovic@kbc-zagreb.hr

00385-01-2388423

References

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.

Reference Type: BACKGROUND

PMID: 32106236 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20546237 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29998767 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28616797 (View on PubMed)

Other Identifiers

DRKS00024581

Identifier Type: REGISTRY

Identifier Source: secondary_id

CR ZAG 02/21 AG 8.1-21/18-2

Identifier Type: -

Identifier Source: org_study_id