Researchers recently found that switching to a preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% in patients with open-angle glaucoma or ocular hypertension significantly reduced intraocular pressure over a full 24-hour period while improving ocular surface disease signs and symptoms.
The researchers, led by Francesco Oddone, of the IRCCS Fondazione Bietti in Rome, conducted the prospective, interventional, noncomparative clinical trial across two Italian centers: IRCCS Fondazione Bietti and the University of Milan’s San Paolo Hospital. They included 38 patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) who had been on benzalkonium chloride (BAK)-latanoprost therapy for at least 6 weeks but exhibited uncontrolled intraocular pressure (IOP) and ocular surface disease (OSD) symptoms.
The researchers also evaluated corneal and conjunctival health, OSD symptoms, and quality of life (QoL) using validated tools such as the 5-Item Dry Eye Questionnaire (DEQ-5) and the 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ25).
Participants underwent 24-hour IOP monitoring at baseline and 3 months after switching from BAK-latanoprost to the preservative-free fixed combination of tafluprost 0.0015% and timolol 0.5% (PF-TTFC). Measurements were taken at eight time points: 8:00 AM, 11:00 AM, 2:00 PM, 5:00 PM, 8:00 PM, 11:00 PM, 2:00 AM, 5:00 AM.
According to the results, which were recently published in Clinical Ophthalmology, mean 24-hour IOP significantly decreased from 17.8 mmHg (95% confidence interval [CI] = 17.1–18.6) at baseline to 15.3 mmHg (95% CI = 14.6–16.1) after 3 months (P < .001). The mean reduction was 2.5 mmHg (–14%), and the greatest reduction was recorded at 11:00 PM (–3.5 mmHg, –18.4%).
PF-TTFC reduced IOP both during the day and at night, but demonstrated greater effectiveness at nighttime (–2.9 mmHg, –14.9%) compared with daytime (–2.3 mmHg, –13.6%). This result was statistically and clinically significant.
Corneal fluorescein staining improved in 52.6% of patients, while hyperemia decreased in 63.3%. The number of patients with no or minimal corneal staining increased from 68.4% at baseline to 92.1% after 3 months. In vivo confocal microscopy showed a significant decrease in corneal wing cell size (P < .005), which suggested potential recovery of epithelial homeostasis, though the researchers explained that this effect may take longer to show changes over time.
The mean DEQ-5 score significantly improved from 8.29 to 6.13 (P = .002), which indicated a reduction in discomfort. No statistically significant changes were found in the NEI-VFQ25 composite score, but the researchers noted that the sample size may not have been large enough to detect QoL differences.
PF-TTFC was well tolerated. No serious adverse events were reported. Blepharitis, which was present in 28.9% of patients at baseline, improved in some cases following the therapy switch. One case of new-onset moderate blepharitis was reported as a nonserious adverse event.
“Studies have shown that the higher the number of drops and the required daily administrations, the higher is the chance for the patients [with glaucoma] to experience therapy-related OSD,” the study authors wrote. “The use of preservative-free fixed combinations may improve not only the IOP control, as expected, but also the signs and symptoms of OSD caused by the treatment.”
The researchers concluded that a longer follow-up may provide evidence for the long-term efficacy and tolerability of PF-TTFC, especially in controlling OSD signs and symptoms. They did not evaluate participants’ blood pressure and suggested that clinicians consider effects of blood pressure when considering treatment with beta blockers, especially in cases of normal tension glaucoma.
A full list of disclosures can be found in the published research.