COMfort Eye Trial (COMET) results - a non-inferiority, randomized, investigator-masked, two-parallel group, phase III clinical trial, to evaluate the efficacy and safety of a preservative free formulation of latanoprost versus a reference drug (Xalatan®) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT)

ABSTRACT

Aim

To prove non-inferiority of preservative-free (PF) latanoprost versus benzalkonium chloride (BAK) containing latanoprost in lowering intraocular pressure (IOP) in primary open-angle glaucoma (POAG) or ocular hypertension (OHT) patients.

Design and methods

This phase III, randomized, investigator-masked trial primarily aimed to demonstrate non-inferiority of YSLT PF latanoprost 50 μg/ml (Yonsung GmbH) to latanoprost (Xalatan®) 50 μg/ml (Pfizer) in reducing IOP from Baseline to Week 12. Secondary aims included conjunctival hyperemia evaluation and difference in ocular comfort levels. Total 130 patients with POAG or OHT were enrolled and randomized (1:1 ratio) to receive YSLT or latanoprost, instilling eye drops daily for 12 weeks.

Results

At Week 12, mean diurnal IOP reduction was −7.67 ± 2.104 mmHg for YSLT PF latanoprost and −7.77 ± 2.500 for latanoprost. The 97.5% confidence interval of between-treatment group difference in IOP reduction from Baseline to Week 12 was [−0.846, +∞), not crossing the non-inferiority margin of −1.5 mmHg. A low incidence of mild topical treatment emergent adverse events (TEAEs) was observed in both groups, while no serious TEAEs were reported.

Conclusions

YSLT eye drops demonstrated non-inferiority to latanoprost in reducing IOP. Both products were well tolerated without serious TEAEs reported.

KEYWORDS:

• Glaucoma
• Latanoprost
• preservative-free
• Ocular hypertension

Acknowledgments

Writing and editorial support for manuscript preparation were provided by Pharmabide Ltd., Greece, and funded by Yonsung GmbH, Gottmadingen, Germany.

Declaration of interests

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contribution statement

Youngsik Chung, Areum Baek and Hyunik Shin were involved in the conception and design of the trial. The clinical data were collected and analyzed by Pantelis A. Papadopoulos, Stylianos Kandarakis, Georgios Roussopoulos, Alexandros P. Papadopoulos, Eustathios Georgopoulos, Leonidas Doumazos and Nefeli Ioanna Paizi. This article was drafted by Stylianos Kandarakis and Alexandros Papadopoulos. Final approval of this version was given by the primary investigator, Pantelis A. Papadopoulos, and all the contributing authors. All authors agree to be accountable for all aspects of the work.

Supplementary material

Supplemental data for this article can be accessed online at https://doi.org/10.1080/14740338.2023.2252341

Additional information

Funding

This paper was funded by the Yonsung GmbH, Gottmadingen, Germany. Pharmabide Ltd., Greece, participated in the design, conduct, monitoring, data collection, data management, and data analysis of the study.