Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Multicenter Study
. 2025 Jan 20;45(1):30.
doi: 10.1007/s10792-025-03411-x.

Efficacy and safety of preservative-free anti-glaucomatous eye drops (dorzolamide/timolol) in ocular hypertension and/or glaucoma

Sihem Lazreg  1 , Ahmed Hassan Assaf  2 , Ahmed M Abdelrahman  3 , Mohamed Hosny  3 , Mohamed Shafik Shaheen  4 , Medhat Mohamed Shawky  5 , Tamer Mohamed El-Raggal  6 , Waleed Ali Moustafa Abou Samra  7 , Yehia Salah Eldin Mostafa  8
Affiliations
Multicenter Study

Efficacy and safety of preservative-free anti-glaucomatous eye drops (dorzolamide/timolol) in ocular hypertension and/or glaucoma

Sihem Lazreg et al. Int Ophthalmol. .

Abstract

Purpose: This study evaluated the efficacy, safety, and tolerability of a single-dose, preservative-free (PF) Dorzolamide/Timolol combination (Twinzol-SDU).

Methods: A 3-month single-arm, multicenter, prospective cohort study was conducted in Egypt between January 2021 and October 2022 on previously diagnosed and controlled patients with ocular hypertension and/or glaucoma. Efficacy was assessed using the change in intraocular pressure (IOP) after 6 and 12 weeks. Safety was identified through the change in the incidence of ocular side effects, ocular surface disease index (OSDI) scores and grades, and Time Break-Up time (TBUT).

Results: A total of 382 patients were enrolled in the analysis. After the three-month period of therapy, a significant reduction in IOP was seen (mean change: -1.9, P < 0.001) after switching to PF Dorzolamide/Timolol combination. The rate of ocular abrasion decreased significantly from 30.6% to 1.3% (P < 0.001). The rate of normal aqueous tear production increased from 24.1% to reach 79.4% (P < 0.001). The OSDI scores decreased significantly throughout the study period, with a median score decreased from 41.7 (21.7) to 12.5 (12.5) (P < 0.001). Mild OSDI grades significantly increased from the baseline of 12.6% to reach 24.7%. Moderate OSDI grade decreased at the same rate, from 12.8% to 11.1%. The number of patients with severe OSDI grade substantially decreased from 64.4% to 4.5%, with a P < 0.001. TBUT increased from 9 (3.7) seconds to reach and 12.3 (4) seconds after 12 weeks of treatment (P < 0.001).

Conclusion: Generally, the PF dorzolamide/timolol combination was associated with a significant reduction in IOP and tolerability among glaucoma patients.

Keywords: Dorzolamide; Glaucoma; Ocular Hypertension; Timolol.

PubMed Disclaimer

Conflict of interest statement

Declarations. Conflict of interest: This study and its investigators were fully sponsored and funded by Orchidia Pharmaceutical Industry. Ethical approval: The protocol and its amendments were submitted to independent ethics committees (IECs) of "Genuine Research Center (GRC)" under study code "GRC/ORCDT/EG/37/CT", protocol code number "ORC-001" for review and written approval. It complied with recommendations of the 18th World Health Congress (Helsinki, 1964), laws and regulations, and any applicable guidelines. Consent to participate: All patients signed written informed consent.

References

    1. Kulkarni S, Damji, Buys (2008) Medical management of primary open-angle glaucoma: Best practices associated with enhanced patient compliance and persistency. Patient Prefer Adherence 303. https://doi.org/10.2147/PPA.S4163
    1. Quigley HA (1996) Number of people with glaucoma worldwide. Br J Ophthalmol 80:389–393. https://doi.org/10.1136/bjo.80.5.389 - DOI - PubMed - PMC
    1. Schuster AK, Erb C, Hoffmann EM et al (2020) The Diagnosis and Treatment of Glaucoma. Dtsch Arztebl Int. https://doi.org/10.3238/arztebl.2020.0225 - DOI - PubMed - PMC
    1. Garg A, Gazzard G (2020) Treatment choices for newly diagnosed primary open angle and ocular hypertension patients. Eye 34:60–71. https://doi.org/10.1038/s41433-019-0633-6 - DOI - PubMed
    1. Wilson FM (1979) Adverse external ocular effects of topical ophthalmic medications. Surv Ophthalmol 24:57–88. https://doi.org/10.1016/0039-6257(79)90125-5 - DOI - PubMed

Publication types

MeSH terms

LinkOut - more resources