Trial reportGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie2010
Comparison of the efficacy and tolerability of preservative-free and preservative-containing formulations of the dorzolamide/timolol fixed combination (COSOPT™) in patients with elevated intraocular pressure in a randomized clinical trial.
Trial report in Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.
- Comparative safety and efficacy of brinzolamide/timolol and dorzolamide/timolol in the treatment of glaucoma patients: A systematic review and meta-analysis.European journal of ophthalmology · 2026Pooled it
- Real-World Transition to a Preservative-Free Fixed Combination of Dorzolamide/Timolol: Impact on the Ocular Surface Microenvironment, Safety, Tolerability, and Efficacy.Medicina (Kaunas, Lithuania) · 2026Trial
- Bioequivalence of Preservative-Free and Preserved Omidenepag Isopropyl 0.002% Ophthalmic Solutions in Patients With Primary Open Angle Glaucoma or Ocular Hypertension: Phase 3 DAISY Study.Journal of glaucoma · 2025Trial
- Impact of Preservative-Free Travoprost on Intraocular Pressure and Ocular Surface in Primary Open-Angle Glaucoma Patients.Life (Basel, Switzerland) · 2025Article
- Clinical Benefits of Preservative-Free Treatment for Glaucoma with a Focus on Preservative-Free Latanoprost.Ophthalmology and therapy · 2025Review
- Comparing the Effectiveness and Adherence between Fixed and Non-Fixed Dorzolamide/Timolol Maleate in Open-Angle Glaucoma Patients in Hospital Universiti Sains Malaysia.The Malaysian journal of medical sciences : MJMS · 2023Article
- A Narrative Review of Ocular Surface Disease Related to Anti-Glaucomatous Medications.Ophthalmology and therapy · 2022Review
- Benzalkonium chloride, a common ophthalmic preservative, compromises rat corneal cold sensitive nerve activity.The ocular surface · 2022Article
- Impact of dorzolamide, benzalkonium-preserved dorzolamide and benzalkonium-preserved brinzolamide on selected biomarkers of oxidative stress in the tear film.BMC ophthalmology · 2021Article
- Topical Medication Therapy for Glaucoma and Ocular Hypertension.Frontiers in pharmacology · 2021Review
- Dorzolamide/Timolol Fixed Combination: Learning from the Past and Looking Toward the Future.Advances in therapy · 2021Review
- Management Of Glaucoma In Developing Countries: Challenges And Opportunities For Improvement.ClinicoEconomics and outcomes research : CEOR · 2019Review
- Preservatives in glaucoma medication.The British journal of ophthalmology · 2018Review
- Review
- Comparison of Ocular Pulse Amplitude Lowering Effects of Preservative-Free Tafluprost and Preservative-Free Dorzolamide-Timolol Fixed Combination Eyedrops.BioMed research international · 2015Article
- Intraocular pressure reduction of fixed combination timolol maleate 0.5% and dorzolamide 2% (Cosopt) administered three times a day.Clinical ophthalmology (Auckland, N.Z.) · 2012Article
- Safety, tolerability, and efficacy of fixed combination therapy with dorzolamide hydrochloride 2% and timolol maleate 0.5% in glaucoma and ocular hypertension.Clinical ophthalmology (Auckland, N.Z.) · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe aim of this study was to compare the efficacy and tolerability of preservative-free (PF) and preservative-containing (PC) formulations of the dorzolamide/timolol fixed combination (COSOPT™) in patients with elevated intraocular pressure (IOP).
methodsA parallel, randomized, double-masked study was conducted. After a 3-week run-in on timolol, patients with ocular hypertension, as confirmed by an IOP ≥22 mmHg, were randomized 1:1 to receive PF or PC dorzolamide/timolol twice daily for 12 weeks. IOP was measured at hour 0 (drug trough) and hour 2 (drug peak) at baseline (last day of 3-week timolol run-in), and weeks 2, 6 and 12.
resultsA total of 261 patients were randomized. Mean baseline IOPs were 23.7 mmHg for both treatments at hour 0 and 21.2 mmHg for PF dorzolamide/timolol and 21.4 mmHg for PC dorzolamide/timolol at hour 2. At all study time points (trough and peak at weeks 2, 6, and 12), the difference between treatments in mean change from baseline IOP was <0.5 mmHg. The 95% confidence intervals for the estimated treatment difference (PF minus PC) in mean change from baseline IOP at week 12 was -0.86 to 0.23 mmHg for trough (primary endpoint) and -0.39 to 0.67 mmHg for peak (secondary endpoint). The most common adverse events were ocular burning/stinging, reported by 16.0% and 21.5% of patients receiving PF and PC dorzolamide/timolol respectively, and taste perversion, reported by 3.1% and 5.4% of patients receiving PF and PC dorzolamide/timolol respectively.
conclusionsIn patients with elevated IOP, PF and PC dorzolamide/timolol were equivalent in efficacy for change in trough and peak IOP, and had generally similar tolerability.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.