scholarly journals Bimatoprost ophthalmic solution 0.03% lowered intraocularpressure of normal-tension glaucoma with minimal adverse events [Corrigendum]

2013 ◽  
pp. 1363
Author(s):  
Toyoaki Tsumura ◽  
Hirotaka Suzumura ◽  
Keiji Yoshikawa ◽  
Kimura ◽  
Sasaki ◽  
...  
Keyword(s):  
Adverse Events ◽  
Ophthalmic Solution ◽  
Normal Tension Glaucoma

scholarly journals Bimatoprost ophthalmic solution 0.03% lowered intraocular pressure of normal-tension glaucoma with minimal adverse events

2012 ◽  
pp. 1547 ◽  
Author(s):  
Toyoaki Tsumura ◽  
Hirotaka Suzumura ◽  
Keiji Yoshikawa ◽  
Kimura ◽  
Sasaki ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Adverse Events ◽  
Ophthalmic Solution ◽  
Normal Tension Glaucoma

scholarly journals Sustainability of Intraocular Pressure Reduction of Travoprost Ophthalmic Solution in Subjects with Normal Tension Glaucoma

2016 ◽  
Vol 33 (3) ◽  
pp. 435-446 ◽  
Author(s):  
Tomoko Naito ◽  
Shinichi Okuma ◽  
Mikio Nagayama ◽  
Shiro Mizoue ◽  
Mineo Ozaki ◽  
...  
Keyword(s):  
Intraocular Pressure ◽  
Ophthalmic Solution ◽  
Normal Tension Glaucoma ◽  
Pressure Reduction ◽  
Intraocular Pressure Reduction

scholarly journals Topical lipoic acid choline ester eye drop for improvement of near visual acuity in subjects with presbyopia: a safety and preliminary efficacy trial

Eye ◽  
2021 ◽  
Author(s):  
Michael S. Korenfeld ◽  
Stella M. Robertson ◽  
Jerry M. Stein ◽  
David G. Evans ◽  
Steven H. Rauchman ◽  
...  
Keyword(s):  
Visual Acuity ◽  
Adverse Events ◽  
Lipoic Acid ◽  
Ophthalmic Solution ◽  
Choline Ester ◽  
Primary Endpoints ◽  
Corrected Distance Visual Acuity ◽  
Near Visual Acuity ◽  
Further Development

Abstract Objectives This study evaluated the safety of topical lipoic acid choline ester (UNR844, 1.5%) ophthalmic solution and its efficacy in improving distance-corrected near visual acuity (DCNVA) in subjects with presbyopia. Subjects and methods This was a prospective, randomized, double-masked, and multicentre clinical trial. Subjects with a diagnosis of presbyopia (n = 75) were randomized 2:1 to UNR844 or placebo. On days 1–7, all subjects were dosed unilaterally (twice a day, b.i.d.) in their non-dominant eye to ensure safety and tolerability prior to days 8–91 when dosing was changed to bilateral (b.i.d.). Clinical assessments, including DCNVA and adverse events (AEs), were recorded at each study visit. Patients who completed the study were recruited into a non-interventional follow-up study that monitored them until 7 months after their final UNR844 exposure. The primary endpoints were safety and the mean change in DCNVA from baseline in the study eye. Results UNR844 administration (n = 50) produced no safety concerns and was well-tolerated, with no clinically-relevant changes in best-corrected distance visual acuity, pupil size, intraocular pressure, or discontinuations due to adverse events. DCNVA improved in the study eye in the UNR844 group compared to placebo during the 91 days of treatment [UNR844 vs. placebo, mean change in LogMAR (SD); −0.159 (0.120) vs. −0.079 (0.116)]. Bilateral DCNVA improved, with 53.1% UNR844 vs. 21.7% placebo subjects gaining ≥10 letters. Improvements in DCNVA were sustained at 5 and 7 months after UNR844 dosing ceased. Conclusions These results support further development of UNR844 ophthalmic solution for the treatment of presbyopia.

scholarly journals Safety and Efficacy of Topical Lotilaner Ophthalmic Solution 0.25% for the Treatment of Demodex Blepharitis: A Pilot Study

2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Roberto Gonzalez-Salinas ◽  
Elizabeth Yeu ◽  
Mark Holdbrook ◽  
Stephanie N. Baba ◽  
Juan Carlos Ceballos ◽  
...  
Keyword(s):  
Adverse Events ◽  
Ophthalmic Solution ◽  
Safety And Efficacy ◽  
Contact Lens Wear ◽  
Ocular Irritation ◽  
Randomized Controlled Studies ◽  
Corrected Distance Visual Acuity ◽  
Structural Abnormalities ◽  
Mite Density ◽  
Upper Lid

Purpose. Evaluate safety and efficacy of topical lotilaner ophthalmic solution, 0.25% for the treatment of Demodex blepharitis. Patients and Methods. 15 patients with Demodex blepharitis, defined as >10 collarettes on the upper lid, lid margin erythema, and Demodex density of ≥1.5 mites/lash on microscopy, were treated bid for 28 days with lotilaner ophthalmic solution, 0.25%. Contact lens wear, artificial eyelashes, and lid structural abnormalities were among the exclusion criteria. No other antibacterial, antiparasitic, or anti-inflammatory treatment or lid hygiene products were permitted. Patients were assessed on Days 7, 14, 28, 60, and 90. Outcome measures were changes in collarette grade and mite density on Day 28. Adverse events and changes in intraocular pressure (IOP), corrected distance visual acuity (CDVA), and slit-lamp biomicroscopy were assessed. Results. Mean collarette grade (upper lids) improved from 3.07 ± 0.21 to 0.79 ± 0.19 on Day 28; the change was statistically significant for both upper and lower lids from Day 14 on. Mean mite density per lash decreased from 2.28 ± 0.16 at baseline to 0.14 ± 0.05 at Day 28 p < 0.0001 . Mite eradication (0 mites) was documented in 57.1% of eyes. The effects were durable through Day 90. There were no adverse events and little to no change in CDVA or IOP. The drop was well tolerated, with no discontinuations due to ocular irritation. Conclusion. Topical lotilaner ophthalmic solution, 0.25% for 4 weeks, showed promising efficacy for the treatment of Demodex blepharitis. This novel treatment appears to be safe and well tolerated. Randomized controlled studies are needed to confirm the results.

scholarly journals Efficacy and Safety of Switching Prostaglandin Analog Monotherapy to Tafluprost/Timolol Fixed-Combination Therapy

2018 ◽  
Vol 2018 ◽  
pp. 1-9
Author(s):  
Kazuyoshi Kitamura ◽  
Tatsuya Chiba ◽  
Fumihiko Mabuchi ◽  
Kiyotaka Ishijima ◽  
Shu Omoto ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Adverse Events ◽  
Primary Open Angle Glaucoma ◽  
Fixed Combination ◽  
Open Angle Glaucoma ◽  
Normal Tension Glaucoma ◽  
Efficacy And Safety ◽  
Prostaglandin Analog ◽  
Conjunctival Hyperemia ◽  
Protocol Switching

Purpose. To assess the efficacy and safety of switching from prostaglandin analog (PGA) monotherapy to tafluprost/timolol fixed-combination (Taf/Tim) therapy. Subjects and Methods. Patients with primary open-angle glaucoma, normal-tension glaucoma, or ocular hypertension who had received PGA monotherapy for at least 3 months were enrolled. Patients were examined at 1, 2, and 3 months after changing therapies. Subsequently, the patients were returned to PGA monotherapy. The examined parameters included intraocular pressure (IOP) and adverse events. A questionnaire survey was conducted after the switch to Taf/Tim therapy. Results. Forty patients with a mean age of 66.5 ± 10.3 years were enrolled; 39 of these patients completed the study protocol. Switching to Taf/Tim significantly reduced the IOP from 18.2 ± 2.6 mmHg at baseline to 14.8 ± 2.5 mmHg at 1 month, 15.2 ± 2.8 mmHg at 2 months, and 14.9 ± 2.5 mmHg at 3 months (P<0.001). Switching back to the original PGA monotherapy returned the IOP values to baseline levels. Taf/Tim reduced the pulse rate insignificantly. No significant differences were observed in blood pressure, conjunctival hyperemia, or corneal adverse events. A questionnaire showed that the introduction of Taf/Tim did not significantly influence symptoms. Conclusions. Compared with PGA monotherapy, Taf/Tim fixed-combination therapy significantly reduced IOP without severe adverse events.

scholarly journals Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease

2018 ◽  
Vol 29 (4) ◽  
pp. 394-401 ◽  
Author(s):  
Kelly K Nichols ◽  
Eric D Donnenfeld ◽  
Paul M Karpecki ◽  
John A Hovanesian ◽  
Aparna Raychaudhuri ◽  
...  
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Dry Eye ◽  
Ophthalmic Solution ◽  
Pooled Analysis ◽  
Dry Eye Disease ◽  
Eye Disease ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Schirmer Tear Test

Purpose: Characterize the safety and tolerability of lifitegrast ophthalmic solution 5.0% for the treatment of dry eye disease. Methods: Pooled data from five randomized controlled trials were analyzed. Key inclusion criteria were adults with dry eye disease (Schirmer tear test score ⩾1 and ⩽10 mm, eye dryness score ⩾40 (visual analog scale 0–100), corneal staining score ⩾2.0 (0–4 scale)). Participants were randomized to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 84 or 360 days. Treatment-emergent adverse events and drop comfort scores were assessed. Results: Overall, 2464 participants (lifitegrast, n = 1287; placebo, n = 1177) were included. Ocular treatment-emergent adverse events occurring in >5% in either group were instillation site irritation (lifitegrast, 15.2%; placebo, 2.8%), instillation site reaction (lifitegrast, 12.3%; placebo, 2.3%), and instillation site pain (lifitegrast, 9.8%; placebo, 2.1%); the most common (> 5%) nonocular treatment-emergent adverse event was dysgeusia (lifitegrast, 14.5%; placebo, 0.3%). The majority of treatment-emergent adverse events were mild to moderate in severity. Discontinuation due to treatment-emergent adverse events occurred in 7.0% (lifitegrast) versus 2.6% (placebo) of participants (ocular: 5.5% vs 1.5%; nonocular: 1.9% vs 1.1%). Drop comfort scores with lifitegrast improved within 3 min of instillation and the score at 3 min improved across visits (12-week trials (both eyes, day 84 vs 0): 2.0 vs 3.3; SONATA (day 360 vs 0): right eye, 1.2 vs 1.7; left eye, 1.2 vs 1.8). Conclusion: Lifitegrast ophthalmic solution 5.0% appeared to be safe and well tolerated for the treatment of dry eye disease. Drop comfort with lifitegrast improved within 3 min of instillation.

Postvaccination Adverse Events

2010 ◽  
Vol 44 (12) ◽  
pp. 16
Author(s):  
STEPHEN I. PELTON
Keyword(s):  
Adverse Events
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