Teprotumumab-Related Adverse Events in Thyroid Eye Disease: A Multicenter Study.

Purpose: To assess the duration, incidence, reversibility, and severity of adverse events (AEs) in patients with thyroid eye disease (TED) treated with teprotumumab.

Design: Multicenter, retrospective, observational cohort study.

Participants: Patients with TED of all stages and activity levels treated with at least 4 infusions of teprotumumab.

Safety and Efficacy of Twice-Daily Pilocarpine HCl in Presbyopia: The Virgo Phase 3, Randomized, Double-Masked, Controlled Study.

Purpose: To evaluate the safety, efficacy, and pharmacokinetics of pilocarpine hydrochloride 1.25% (Pilo hereafter) compared with vehicle when administered bilaterally, twice daily (6 hours apart) for 14 days in participants with presbyopia.

Design: Phase 3, randomized (1:1), controlled, double-masked, multicenter study.

Effectiveness of An Intraoperative Lagophthalmos Formula for Levator Resection in Patients With Congenital Ptosis.

Purpose: To evaluate the effectiveness of an intraoperative lagophthalmos formula (IOLF) for levator resection in congenital ptosis and investigate the optimal preoperative conditions for IOLF application.

Methods: This retrospective interventional cohort study evaluated 30 eyelids of 22 patients with congenital ptosis who underwent levator resection using the IOLF to calculate the extent of surgical correction under general anesthesia. Surgical success was defined as margin reflex distance-1 (MRD1)≥3 mm in each eye and a difference of MRD1 1 mm between the eyes at 6 months postoperatively.

Spontaneous rupture of secondary iris inclusion cyst causing acute glaucoma and other ocular sequelae.

A 63-year-old woman with a known secondary iris inclusion cyst in her right eye presented with headache, blurry vision, and eye pain of 3 days' duration. Initial findings were notable for significant decrease in vision and elevated intraocular pressure in the right eye, with diffuse microcystic corneal edema, diffuse anterior chamber flare with minimal cellular reaction, and a significantly decompressed iris inclusion cyst. On gonioscopy, the right eye was open to scleral spur, and no pigment was visualized.

Phentolamine Mesylate Ophthalmic Solution Provides Lasting Pupil Modulation and Improves Near Visual Acuity in Presbyopic Glaucoma Patients in a Randomized Phase 2b Clinical Trial.

Purpose: Phentolamine mesylate ophthalmic solution (PMOS), applied to the eye topically, was shown previously to have beneficial effects in patients with dim light vision disturbances (DLD), including decreased pupil diameter (PD), improved best-corrected distance visual acuity (BCDVA), as well as lower intraocular pressure (IOP). The ORION-1 trial evaluated the long-term safety and efficacy of PMOS in a glaucomatous, presbyopic population.

Patients And Methods: In this randomized, double-masked, multi-center, placebo-controlled, multiple-dose Phase 2b trial, 39 patients with elevated IOP were randomized to receive one evening dose of study medication or placebo for 14 days.

A single vectored thermal pulsation treatment for meibomian gland dysfunction increases mean comfortable contact lens wearing time by approximately 4 hours per day.

Purpose: To evaluate the effect of a single vectored thermal pulsation (VTP) treatment in contact lens wearers with meibomian gland dysfunction (MGD) and dry eye symptoms.

Methods: The prospective, nonsignificant risk, open-label, randomized, multi-center clinical trial included 55 soft contact lens (SCL) wearers with MGD and evaporative dry eye. Subjects were randomized to the single VTP treatment group or an untreated control.

Oral administration of the 11β-hydroxysteroid-dehydrogenase type 1 inhibitor RO5093151 to patients with glaucoma: an adaptive, randomised, placebo-controlled clinical study.

Background/aims: Cortisol is involved in the regulation of intraocular pressure (IOP). This study aimed to assess the effect of 11β-hydroxysteroid-dehydrogenase type 1 (11βHSD1) inhibition by oral administration of RO5093151 on IOP.

Methods: The exposure of key ocular compartments following oral administration was assessed in rabbits.

Pharmacokinetics and safety of olopatadine hydrochloride 0.77% in healthy subjects with asymptomatic eyes: data from 2 independent clinical studies.

Purpose: To assess the pharmacokinetics and safety of hydrochloride ophthalmic solution 0.77% olopatadine from 2 independent (Phase I and Phase III, respectively) clinical studies in healthy subjects.

Materials And Methods: The Phase I, multicenter, randomized (2:1), vehicle-controlled study was conducted in subjects ≥18 years old (N=36) to assess the systemic pharmacokinetics of olopatadine 0.

Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial.

PurposeTo determine whether intraocular pressure (IOP) lowering with fixed-combination brinzolamide/brimonidine (BBFC) adjunctive to a prostaglandin analog (PGA) was superior to that of vehicle+PGA in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled with PGA monotherapyMethodsThis 6-week, multicenter, randomized, double-masked, parallel-group trial was conducted at 30 clinical sites in the United States between October 2013 and May 2014. Eligible patients were adults with open-angle glaucoma or ocular hypertension and with mean IOP ≥21 and <32 mm Hg, whereas receiving an open-label PGA (latanoprost, bimatoprost, or travoprost). Patients instilled a PGA once-daily in a run-in phase before randomization to masked BBFC or vehicle adjunctive treatment.

Six-Month Intraocular Pressure Reduction with a Topical Bimatoprost Ocular Insert: Results of a Phase II Randomized Controlled Study.

Purpose: Improving adherence to manage elevated intraocular pressure (IOP) remains an unmet need. A topical bimatoprost ocular insert was compared with twice-daily timolol eye drops in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT) treated for 6 months.

Design: Parallel-arm, multicenter, double-masked, randomized, controlled trial.

Late-day intraocular pressure-lowering efficacy and tolerability of travoprost 0.004% versus bimatoprost 0.01% in patients with open-angle glaucoma or ocular hypertension: a randomized trial.

Background: Medications to control intraocular pressure (IOP) are frequently preserved using benzalkonium chloride (BAK), which can negatively affect the ocular surface. Data are needed to assess efficacy and safety of prostaglandin drugs preserved with and without BAK. The present study compared the efficacy and safety of BAK-free travoprost 0.

Double-masked, randomized, dose-response study of AR-13324 versus latanoprost in patients with elevated intraocular pressure.

Objective: AR-13324 is a small-molecule inhibitor of Rho kinase and a norepinephrine transporter. The objective of this 28-day study was to evaluate the ocular hypotensive efficacy and safety of AR-13324 ophthalmic solution compared with a positive control, latanoprost ophthalmic solution, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Design: Double-masked, randomized study in 22 private practice ophthalmology clinics.

Sustained intraocular pressure reduction throughout the day with travoprost ophthalmic solution 0.004%.

Background: The purpose of this study was to characterize intraocular pressure (IOP) reduction throughout the day with travoprost ophthalmic solution 0.004% dosed once daily in the evening.

Methods: The results of seven published, randomized clinical trials including at least one arm in which travoprost 0.

Comparison of the diurnal ocular hypotensive efficacy of travoprost and latanoprost over a 44-hour period in patients with elevated intraocular pressure.

Background: Prostaglandin analogues are effective ocular hypotensive agents and are being used increasingly in the treatment of elevated intraocular pressure (IOP). These agents are typically dosed once daily.

Objectives: A pilot study was conducted to evaluate the duration of travoprost's IOP-lowering efficacy up to 84 hours after the final dose in patients with open-angle glaucoma.

A comparison of the efficacy and tolerability of brimonidine and latanoprost in adults with open-angle glaucoma or ocular hypertension: a three-month, multicenter, randomized, double-masked, parallel-group trial.

Background: Many physicians recommend either brimonidine or latanoprost as firstline therapy for chronic open-angle glaucoma or ocular hypertension. However, a search of MEDLINE indicates that there have been few head-to-head comparisons of the 2 monotherapies in a clinical setting.

Objective: This study compared the clinical efficacy and tolerability of brimonidine 0.

Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: a 30-day comparison with latanoprost.

Purpose: To compare the safety and efficacy of bimatoprost and latanoprost in patients with primary open-angle glaucoma or ocular hypertension.

Methods: This was a 30-day, multicenter, double-masked, randomized, clinical trial. Patients (n = 64) diagnosed with primary open-angle glaucoma or ocular hypertension were randomly assigned to receive bimatoprost 0.

Timolol hemihydrate vs timolol maleate to treat ocular hypertension and open-angle glaucoma.

Purpose: We compared the therapeutic efficacy and safety of timolol hemihydrate to timolol maleate in patients with ocular hypertension and chronic open-angle glaucoma.

Methods: We conducted this three-month study as a multicentered, masked, parallel group comparison. Both the 0.