Publications by authors named "Gail Torkildsen"
The melanocortin receptor pan-agonist PL9643, a potential therapy for ocular diseases, was investigated in a phase 2, 12-week study in patients with dry eye disease (DED). This was a placebo-controlled study evaluating efficacy and safety of thrice-daily PL9643. Placebo (vehicle) was similar to tears.
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- The trial aimed to assess the safety and effectiveness of OC-01, a nasal spray for treating dry eye disease.
- Patients aged 22 and older, previously using artificial tears, were randomly assigned to receive different doses of OC-01 or a control nasal spray for 28 days.
- Results showed significant improvements in tear production and reduced eye dryness in patients using OC-01, with mild and temporary side effects like sneezing and coughing, suggesting further studies are needed.
Article Synopsis
- Dry eye disease is characterized by symptoms like irritation and pain, and the study investigates OC-02 (simpinicline solution) nasal spray as a novel treatment option.
- The Phase II PEARL trial involved 165 adult participants with specific eye disease criteria, randomly assigned to receive either the OC-02 spray at various doses or a control solution.
- Results showed that the OC-02 spray significantly improved eye symptoms and dryness in a dose-dependent manner compared to the control, highlighting its potential effectiveness for dry eye treatment.
Purpose: To evaluate the safety and effectiveness of the intranasal tear neurostimulator (ITN) in improving dry eye symptoms assessed in a controlled adverse environment (CAE®).
Methods: Study 1: Multicenter, subject-masked, randomized-sequence, crossover design. Single intranasal (active) and extranasal (control) ITN administration during CAE exposure.
Purpose: A contact lens (CL)-based drug delivery system for therapeutic delivery of the antihistamine ketotifen was tested in 2 parallel, conjunctival allergen challenge-based trials.
Methods: Both trials employed the same multicenter, randomized, placebo-controlled protocol. Test lenses were etafilcon A with 0.
Purpose: The studies reported here aimed to assess the safety and tolerability of cetirizine ophthalmic solution 0.24%, a new topical ophthalmic medication approved by the US Food and Drug Administration for the treatment of ocular itching associated with allergic conjunctivitis.
Patients And Methods: Three clinical studies evaluated cetirizine ophthalmic solution 0.
Purpose: To evaluate the safety and efficacy of topical TOP1630, a novel nonsystemic kinase inhibitor, in dry eye disease (DED).
Patients And Methods: A randomized, double-masked, parallel-group trial of 0.1% TOP1630 ophthalmic solution TID or placebo (vehicle without active drug) was conducted in DED subjects (n=61).
Purpose: To compare the efficacy, safety, and tolerability of waterfree cyclosporine formulation (CyclASol) at 2 concentrations (0.1% and 0.05% of cyclosporine [CsA]) to vehicle when applied twice daily for 16 weeks in patients with dry eye disease (DED).
View Article and Find Full Text PDFPurpose: The purpose of these Phase III studies was to evaluate the efficacy and safety of cetirizine ophthalmic solution 0.24% compared with vehicle in the treatment of allergen-induced conjunctivitis using the Ora conjunctival allergen challenge (CAC) model.
Methods: The single-center (Study 1) and multi-center (Study 2), double-masked, randomized, vehicle-controlled, parallel group, CAC studies were conducted over ~5 weeks and four study visits.
Article Synopsis
- The study evaluated the safety and effectiveness of brimonidine tartrate ophthalmic solution (0.025%) for treating ocular redness by analyzing integrated data from multiple controlled studies.
- Results showed that participants using brimonidine experienced significantly lower levels of ocular redness compared to those using a vehicle (placebo) across various assessment points, with no signs of rapid tolerance developing.
- The treatment demonstrated a low incidence of adverse effects, with the most common issues being reduced visual acuity and conjunctival hyperemia, both similar between the brimonidine and vehicle groups.
Purpose: The intranasal tear neurostimulator (ITN) activates the nasolacrimal pathway, which is involved with basal and bolus tear secretion. These studies characterized the acute and long-term effectiveness of the ITN in stimulating tear production in subjects with dry eye disease (DED).
Methods: Study 1: Randomized, double-masked, dual-controlled, 1-day crossover.
Article Synopsis
- The study evaluated the effectiveness and safety of brimonidine tartrate ophthalmic solution (0.025%) for reducing eye redness in adults.
- Participants aged 40 and above were randomly assigned to receive either brimonidine or a placebo over four weeks, with assessments performed at multiple time points.
- Results showed significant reductions in ocular redness with brimonidine, minimal adverse effects, and no signs of rebound redness or tachyphylaxis after discontinuation.
- The conclusions indicated that brimonidine is both safe and effective for managing eye redness.
Article Synopsis
- Artificial tears like Rohto Dry-Aid™ and Systane Ultra are commonly used treatments for dry eye disease (DED), but there's limited research comparing their effectiveness.
- A study was conducted to evaluate Rohto Dry-Aid™ against Systane Ultra over a 30-day period, measuring factors such as ocular staining, visual function, and discomfort levels.
- Results indicated that both products had similar effects on ocular symptoms, but participants using Rohto reported better relief during visual activities, suggesting it may provide longer-lasting comfort throughout the day.
Purpose: Two individual phase 3 conjunctival allergen challenge (CAC) studies of similar design have assessed the efficacy and safety of olopatadine hydrochloride (HCl) 0.77% for the treatment of allergic conjunctivitis. The purpose of this study is to evaluate the integrated efficacy and safety of olopatadine HCl 0.
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- The study aimed to evaluate the effectiveness and safety of a sustained-release dexamethasone insert (Dextenza™) for allergic conjunctivitis.
- The randomized, double-masked trial included subjects with positive allergen reactions, assessing outcomes like itching and redness over 42 days following treatment.
- Results showed Dextenza performed better than the vehicle insert in reducing symptoms, although clinical significance was not fully achieved, with both groups reporting a similar rate of adverse events.
Objective: The aim of this study was to evaluate the effects of cyclosporine ophthalmic emulsion 0.05% on ocular surface staining and visual performance in patients with dry eye.
Methods: This was a single-center, 6-month, open-label, Phase IV study.
Purpose: To evaluate the clinical safety and comfort of a new benzalkonium chloride-free Visine(®) lubricant eye drop formulation (Hydroblend™ and GentlePur™) in healthy and dry eye subjects.
Methods: This was a single-site, open-label clinical study comprised of 22 healthy and 22 dry eye subjects. Subjects were instructed to instill 1-2 drops of the test product four times a day for 2 weeks and were examined at visit 1 (day 0), visit 2 (day 7), and visit 3 (day 14).
Background: Symptom relief for the duration of 24 hours after treatment would benefit patients with allergic conjunctivitis.
Objective: To compare the safety and efficacy of olopatadine 0.77% with vehicle or olopatadine 0.
Article Synopsis
- The study aimed to evaluate the effectiveness and safety of a new 0.77% olopatadine eye drop solution for treating allergic conjunctivitis using a specific allergy test.
- In a 5-week trial with 345 participants, those receiving olopatadine 0.77% showed significant improvements in reducing eye itching compared to lower doses and placebo, both immediately after and 24 hours later.
- The results indicated that olopatadine 0.77% not only provided quick relief from itching but also had a good safety profile, making it a promising treatment for allergic conjunctivitis.
Purpose: To assess the efficacy and safety of lifitegrast ophthalmic solution 5.0% compared with placebo in subjects with dry eye disease.
Design: Prospective, randomized, double-masked, placebo-controlled, parallel arm, multicenter clinical trial.
Purpose: To evaluate the safety and efficacy of ophthalmic MIM-D3, a tyrosine kinase TrkA receptor agonist, in patients with dry eye.
Design: A prospective, two-center, randomized, double-masked, placebo-controlled Phase 2 study.
Methods: A total of 150 dry eye patients were randomized 1:1:1 to study medication (1% MIM-D3, 5% MIM-D3, or placebo) and dosed twice daily (BID) for 28 days.
Allergic conjunctivitis is a clinical reaction to environmental allergens and is manifested by ocular itching caused by IgE-induced mast cell degranulation. Bepotastine besilate is a selective H(1)-antagonist with mast cell stabilizing properties. This report examines the reduction of ocular itching integrated from two conjunctival allergen challenge (CAC) clinical trials comparing bepotastine besilate ophthalmic solution (BBOS) 1.
View Article and Find Full Text PDFPurpose: To investigate the efficacy and safety of an investigational integrin antagonist (SAR 1118) ophthalmic solution compared to placebo (vehicle) in subjects with dry eye disease.
Design: Multicenter, prospective, double-masked, placebo-controlled trial.
Methods: A total of 230 dry eye subjects selected with use of a controlled adverse environment were randomized 1:1:1:1 to receive SAR 1118 (0.
Purpose: This clinical trial evaluated the safety and effectiveness of bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo for the treatment of ocular itching and conjunctival hyperemia (redness) using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis when dosed 16 h before a CAC test.
View Article and Find Full Text PDFPurpose: To assess safety and efficacy of EGP-437 (dexamethasone phosphate 40 mg/mL [DP]) in dry eye patients.
Methods: The study employed a prospective, single-center, double-masked design utilizing a Controlled Adverse Environment (CAE). Patients (n = 103) with confirmed signs and symptoms of dry eye syndrome were randomized into 1 of 3 iontophoresis treatment groups: 7.