The objective of the study is to demonstrate a change in osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears lubricating drops.

开始日期2015-10-01

申办/合作机构

Koffler Vision Group

[+1]

NCT01860664 / Terminated临床2期

Phase 2 EFFICACY AND SAFETY OF HYDROCORTISONE OPHTHALMIC OINTMENT - VERSUS PLACEBO IN THE TREATMENT OF ALLERGIC CONJUNCTIVITIS

The purpose of this study is to determine the safety and effectiveness of hydrocortisone ophthalmic ointment compared to placebo in the treatment of Allergic Conjunctivitis.

开始日期2013-05-01

申办/合作机构

Koffler Vision Group

[+1]

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2015-12-01·Ophthalmology1区 · 医学

Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease

1区 · 医学

Article

作者: Sall, Kenneth ; Semba, Charles P ; Latkany, Robert ; Tauber, Joseph ; Martel, Joseph ; Karpecki, Paul ; Raychaudhuri, Aparna ; Luchs, Jodi ; Smith, Valerie

PURPOSELifitegrast is an integrin antagonist that decreases T-cell-mediated inflammation associated with dry eye disease (DED). We report the results of OPUS-2, a phase III study evaluating the efficacy and safety of lifitegrast compared with placebo for the treatment of DED.DESIGNA 12-week, multicenter, randomized, prospective, double-masked, placebo-controlled clinical trial.PARTICIPANTSAdults aged ≥18 years with use of artificial tears within 30 days, inferior corneal staining score ≥0.5 (0-4 scale), Schirmer tear test (without anesthesia) ≥1 and ≤10 mm, and eye dryness score ≥40 (0-100 visual analogue scale [VAS]).METHODSSubjects were randomized 1:1 after 14-day placebo run-in to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 84 days.MAIN OUTCOME MEASURESCo-primary efficacy end points were change, from baseline to day 84, in eye dryness score (VAS, both eyes) and inferior corneal fluorescein staining score in the designated study eye. Secondary end points were change, from baseline to day 84, in ocular discomfort score (0-4 scale) in study eye, eye discomfort score (VAS), total corneal staining score in the study eye, and nasal conjunctival lissamine green staining score (0-4 scale) in the study eye. Treatment-emergent adverse events (TEAEs) were recorded.RESULTSA total of 718 subjects were randomized: placebo, n = 360; lifitegrast, n = 358 (intent-to-treat population). Lifitegrast-treated subjects experienced greater improvement in eye dryness than placebo-treated subjects (treatment effect, 12.61; 95% confidence interval [CI], 8.51-16.70; P < 0.0001). There was no between-group difference in inferior corneal staining (treatment effect, 0.03; 95% CI, -0.10 to 0.17; P = 0.6186). There was nominally significant improvement of secondary symptom end points among lifitegrast-treated subjects: ocular discomfort (nominal P = 0.0005) and eye discomfort (nominal, P < 0.0001). There were no between-group differences on secondary signs: total corneal staining and nasal lissamine staining. More lifitegrast-treated subjects (33.7%) than placebo-treated subjects (16.4%) experienced ocular TEAEs; no ocular TEAEs were serious.CONCLUSIONSLifitegrast met the co-primary symptom end point (eye dryness) but not the co-primary sign end point (inferior corneal staining). Secondary end point findings were consistent with this pattern. Most ocular TEAEs were mild to moderate; there were no unexpected TEAEs. Lifitegrast warrants further consideration as a treatment for DED.

2010-11-01·Optometry and Vision Science4区 · 医学

Limitations of Current Antibiotics for the Treatment of Bacterial Conjunctivitis

4区 · 医学

Review

作者: Comstock, Timothy L ; Paterno, Michael R ; Karpecki, Paul

Bacterial conjunctivitis is a common ocular infection that is generally treated empirically with a broad-spectrum antibiotic. The more common pathogens causing bacterial conjunctivitis include Staphylococcus aureus, Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus epidermidis, and Moraxella species. Several antibiotics traditionally used to treat bacterial conjunctivitis are no longer widely prescribed because of increased bacterial resistance and/or safety concerns. The introduction of the fluoroquinolone class of anti-infectives offered effective and better tolerated treatment options. Nonetheless, successful therapy for bacterial conjunctivitis continues to be limited by several factors. A primary concern is the development of bacterial resistance that may be impacted not only by widespread antibiotic use but also by antibacterial pharmacokinetics, such as maintenance of insufficient bactericidal concentrations at the site of infection. In addition, poor adherence to prescribed regimens that require frequent administration, along with undesirable adverse events, affects the development of bacterial resistance and the success of treatment regimens. This article reviews current antibacterial agents used to treat bacterial conjunctivitis, factors that limit their successful use in treatment, and options for future development of more effective topical ophthalmic anti-infective agents.

2010-05-01·Eye & Contact Lens: Science & Clinical Practice4区 · 医学

Improved Signs, Symptoms, and Quality of Life Associated With Dry Eye Syndrome: Hydroxypropyl Cellulose Ophthalmic Insert Patient Registry

4区 · 医学

Article

作者: Nelinson, Donald S ; Koffler, Bruce H ; McDonald, Marguerite

OBJECTIVESTo evaluate the acceptability, ease of use, and efficacy of hydroxypropyl cellulose ophthalmic inserts in reducing signs and symptoms of moderate-to-severe dry eye syndrome (DES), and improving quality of life (QoL) and activities of daily living (ADL).METHODSThe multicenter, prospective, open-label, 4-week registry comprised 520 patients with bilateral DES and a history of artificial tear use, or a desire to use artificial tears within the previous week. Visit 1 encompassed a clinical evaluation and symptom and QoL questionnaires, including the Ocular Surface Disease Index. Patients were trained to use inserts, which were used once daily, thereafter, as monotherapy or with existing therapy. At visit 2, clinical evaluation and questionnaires evaluated changes in signs, symptoms, ADL, and QoL. Adverse events were monitored throughout the registry.RESULTSThere were 418 (80.4%) completers. Statistically significant improvements in discomfort, burning, dryness, grittiness, stinging, and light sensitivity, as well as clinical signs of keratitis, conjunctival staining, and tear volume were seen (P<0.05). Mean Ocular Surface Disease Index total scores improved by 21.3% (P<0.05). Blurred vision, affecting 8.7% of patients, was the most commonly reported adverse event leading to discontinuation.CONCLUSIONSHydroxypropyl cellulose ophthalmic inserts significantly improved signs and symptoms of moderate-to-severe DES, as well as ADL and QoL. Benefits were additive to those seen with patients' existing care.

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