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

May 13, 2021 updated by: Klinički Bolnički Centar Zagreb

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Drug: 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of drug tolerability
Time Frame: 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.
through study completion, an average of 6 months
Change of symptoms of ocular surface disease
Time Frame: 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.
through study completion, an average of 6 months
Change of visual function
Time Frame: 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).
through study completion, an average of 6 months
Change of signs of ocular surface disease
Time Frame: 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)
through study completion, an average of 6 months
Change of tear film stability
Time Frame: 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).
through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the effectiveness of preservative-free latanoprost / timolol FC in terms of changing intraocular pressure values
Time Frame: 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.
through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinički Bolnički Centar Zagreb

Collaborators

University of Zagreb

Investigators

  • Principal Investigator: Sonja Jandroković, MD PhD, Klinicki bolnicki centar Zagreb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 8, 2021

Primary Completion (ANTICIPATED)

September 8, 2021

Study Completion (ANTICIPATED)

December 8, 2021

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

May 13, 2021

First Posted (ACTUAL)

May 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR ZAG 02/21 AG 8.1-21/18-2
  • DRKS00024581 (REGISTRY: DRKS - German Clinical Trials Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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