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

NCT04891588 | Unknown

• 2 other identifiers: CR ZAG 02/21 AG 8.1-21/18-2DRKS00024581
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open-angle Glaucoma; Ocular Hypertension

Keywords

glaucoma; ocular surface disease; preservative; treatment; Prostaglandin/timolol fixed combination; tolerability

Outcome Measures

Primary Outcomes (5)

• Change of drug tolerability

  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.

  through study completion, an average of 6 months

• Change of symptoms of ocular surface disease

  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.

  through study completion, an average of 6 months

• Change of visual function

  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).

  through study completion, an average of 6 months

• Change of signs of ocular surface disease

  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)

  through study completion, an average of 6 months

• Change of tear film stability

  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).

  through study completion, an average of 6 months

Secondary Outcomes (1)

• 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

Study Arms (1)

Switching the preserved to preservative free prostaglandin analog-timolol FC

EXPERIMENTAL

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.

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

Interventions

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

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

Switching the preserved to preservative free prostaglandin analog-timolol FC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinički Bolnički Centar Zagreb: lead
• University of Zagreb: collaborator

Study Sites (1)

Klinički bolnički centar Zagreb

Zagreb, 10000, Croatia

RECRUITING

Related Publications (4)

• 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.

  PMID: 32106236 BACKGROUND

• 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.

  PMID: 20546237 BACKGROUND

• 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.

  PMID: 29998767 BACKGROUND

• 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.

  PMID: 28616797 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension; Glaucoma

Interventions

Solutions

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Sonja Jandroković, MD PhD

  Klinički Bolnički Centar Zagreb

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonja Jandroković, MD PhD

CONTACT

+385 (01) 238 8430; sonja.jandrokovic@gmail.com

Sania Vidas Pauk, MD PhD

CONTACT

+385 (01) 238 8430; sania_vidas@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 18, 2021
• Study Start: March 8, 2021
• Primary Completion: September 8, 2021
• Study Completion: December 8, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)