Evaluation of clinical efficacy and safety of Bibrocathol 2% eye ointment in the treatment of Chronic Blepharoconjunctivitis
<p>Purpose: To assess the efficacy and safety of bibrocathol 2% eye ointment in patients with chronic blepharoconjunctivitis. </p><p>Materials and methods: This was a multi-center, randomized, double-masked, placebo-controlled, parallel-group, phase III study. Patients with chronic...
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Journal of Clinical Research and Ophthalmology - Peertechz Publications,
2022-05-17.
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LEADER | 00000 am a22000003u 4500 | ||
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001 | peertech__10_17352_2455-1414_000096 | ||
042 | |a dc | ||
100 | 1 | 0 | |a Elena Yani |e author |
700 | 1 | 0 | |a Sergey Astakhov |e author |
700 | 1 | 0 | |a Vladimir Brzheskiy |e author |
700 | 1 | 0 | |a Evgeniy Egorov |e author |
700 | 1 | 0 | |a Alexey Seleznev |e author |
700 | 1 | 0 | |a Dorothea Groß |e author |
700 | 1 | 0 | |a Heidi Opitz |e author |
245 | 0 | 0 | |a Evaluation of clinical efficacy and safety of Bibrocathol 2% eye ointment in the treatment of Chronic Blepharoconjunctivitis |
260 | |b Journal of Clinical Research and Ophthalmology - Peertechz Publications, |c 2022-05-17. | ||
520 | |a <p>Purpose: To assess the efficacy and safety of bibrocathol 2% eye ointment in patients with chronic blepharoconjunctivitis. </p><p>Materials and methods: This was a multi-center, randomized, double-masked, placebo-controlled, parallel-group, phase III study. Patients with chronic blepharoconjunctivitis were randomized to apply either bibrocathol 2% (n = 100) or placebo (n = 100) three times a day for 14 days. The primary efficacy endpoint was the change from baseline to Day 15(+1 day) in the total score of signs summarizing the investigators' assessment of the severity of lid oedema, lid erythema, debris, hyperemia, and pouting of Meibomian glands based on slit-lamp examination (modified Intention-to-treat (mITT) set). Safety endpoints included visual acuity, intraocular pressure, and adverse events. Investigators and patients performed an overall assessment of treatment tolerability.</p><p>Results: On Day 15(+1 day) the least square (LS) mean change from baseline in the total sum score of signs was -8.62 (95% CI: -9.16; -8.08) in the bibrocathol group and -6.00 (95%CI: -6.54; -5.45) in the placebo group. The LS means the difference between treatment groups was statistically significant in favor of bibrocathol (-2.63 [95% CI: -3.36, -1.89], p < 0.001). Bibrocathol was statistically significantly superior to placebo in reduction of the individual ocular signs scores and the patient's-assessed ocular discomfort severity (p < 0.001). No safety issues were observed concerning visual acuity, intraocular pressure, and the occurrence of adverse events.</p><p>Conclusions: The study showed superior efficacy of two weeks of treatment with bibrocathol versus placebo in reducing signs and symptoms of chronic blepharoconjunctivitis. Treatment with bibrocathol 2% eye ointment was safe and well-tolerated.</p> | ||
540 | |a Copyright © Elena Yani et al. | ||
546 | |a en | ||
655 | 7 | |a Research Article |2 local | |
856 | 4 | 1 | |u https://doi.org/10.17352/2455-1414.000096 |z Connect to this object online. |