Purpose: A contact lens (CL)-based drug delivery system for therapeutic of the antihistamine ketotifen was tested in 2 parallel, conjunctival allergen challenge-based trials. Methods: Both trials employed same multicenter, randomized, placebo-controlled protocol. Test lenses were etafilcon with 0.019 mg ketotifen; control no added drug. Subjects randomized into 3 treatment groups. Group 1 received test one eye and contralateral eye; chosen to receive randomly selected a 1:1 ratio....

This study introduces a fully automated approach using deep learning-based segmentation to select the conjunctiva as region of interest (ROI) for large-scale, multi-site clinical trials. By integrating precise, objective grading system, we aim minimize inter- and intra-grader variability due perceptual biases. We evaluate impact adding "horizontality" parameter system assess this method's potential enhance precision, reduce sample size, improve trial efficiency. analyzed 29,640 images from...

The goal of this study was to assess the effect a controlled adverse environment (CAE) challenge on subjects with both allergic conjunctivitis and dry eye.Thirty-three were screened 17 completed institutional review board-approved study. Subjects underwent baseline ocular assessments conjunctival allergen (CAC) days 0 3. Those who met redness itching criteria randomized receive either (group A, n = 9) or no B, 8) at day 6. Thirty minutes after CAE/no-CAE, challenged their signs symptoms...

The α2-adrenergic receptor agonist brimonidine has been reported to induce conjunctival blanching in cataract, strabismus, laser refractive, and filtration procedures. Clinicians are often faced with red eyes no apparent underlying pathology. Low-dose reduced ocular redness such subjects efficacy maintained over 1 month negligible rebound redness.

Purpose: To examine the pooled per-protocol ocular end points from two conjunctival allergen challenge (CAC) clinical trials of dual-action antihistamine bepotastine besilate ophthalmic solution (BBOS) 1.5%. Methods: Two Phase III, placebo-controlled, double-masked, randomized were conducted at a total six separate centers using CAC model allergic conjunctivitis. The same study design was employed for both trials, with subjects randomly assigned to either BBOS 1.5% (n=78) or placebo (n=79)...

To assess the efficacy and safety of a novel once-daily 0.77% olopatadine hydrochloride ophthalmic solution in subjects with allergic conjunctivitis (AC) using conjunctival allergen challenge (CAC) model.In this 5-week, multicenter, double-masked, phase 3, randomized trial, aged ≥18 years history AC confirmed positive bilateral CAC response were 2:2:2:1 to receive 0.77%, 0.2%, 0.1%, or vehicle, respectively, following single topical dose each eye. The primary objective was superiority over...

This clinical trial evaluated the safety and effectiveness of bepotastine besilate ophthalmic solutions 1.0% 1.5% compared with placebo for treatment ocular itching conjunctival hyperemia (redness) using allergen challenge (CAC) model allergic conjunctivitis when dosed 16 h before a CAC test.Subjects history were assigned to receive or solution in single-center, randomized, placebo-controlled trial. Eligible subjects (n=107) aged 10 years older who had reproducible positive reaction enrolled...

To evaluate the efficacy and safety of a sustained-release dexamethasone intracanalicular insert (Dextenza™) in model allergic conjunctivitis.This was randomized, double-masked, vehicle-controlled, Phase 2 study. Subjects had to have positive conjunctival allergen challenge (CAC) reaction (bilateral +2 itching redness on 5-point, 0-4 scales) at Visit 1, for 3 time points subsequent visits. who met entry criteria were randomized receive Dextenza or PV (vehicle insert). Challenges occurred...

Purpose/Aims: This study assessed the efficacy and safety of brimonidine tartrate ophthalmic solution, 0.025% for treating ocular redness in adult subjects.Materials Methods: was a single-center, double-masked, randomized, vehicle-controlled, parallel-group subjects ≥40 years, with redness. Subjects were randomized 2:1 to or vehicle, instilled QID four weeks. completed visits, last occurring one week after treatment discontinuation. The investigator on scale 0–4 pre-instillation 5–240...

The purpose of this study was to evaluate the efficacy and safety a dexamethasone intracanalicular ocular insert for treatment allergic conjunctivitis.Multicenter, randomized, double-masked, placebo-controlled, Phase 3 clinical trial.Subjects with conjunctivitis were randomized 1:1 receive or placebo in both eyes evaluated using modified version conjunctival allergen challenge (CAC) model. After inserts placed office, series 4 closely spaced post-insertion CACs conducted at weeks 1, 2,...

Allergic conjunctivitis is an inflammatory condition of the ocular surface characterized by itching, redness, tearing, chemosis, and eyelid swelling. The purpose this study was to assess comparative efficacy ophthalmic antihistamine/mast cell stabilizer solution intranasal steroid at reducing signs symptoms allergic induced conjunctival allergen challenge (CAC) model. Sixty subjects were enrolled in a single center, randomized, placebo-controlled, parallel-treatment, four-visit CAC study....

Olopatadine hydrochloride ophthalmic solution 0.2% (Pataday, Alcon) is a new formulation of olopatadine solution, the first topical ocular antiallergic agent indicated for once-daily dosing. The aim this study was to evaluate safety, efficacy, onset, and duration action in treatment allergic conjunctivitis. Using conjunctival allergen challenge, double-masked, randomized by eye, parallel-group included four visits over 5-week period. Subjects were screened eligibility (visit 1) their...

The studies reported here aimed to assess the safety and tolerability of cetirizine ophthalmic solution 0.24%, a new topical medication approved by US Food Drug Administration for treatment ocular itching associated with allergic conjunctivitis.Three clinical evaluated 0.24% administration: Phase I prospective, single-center, open-label, pharmacokinetic (PK) study (N=11) evaluating single-dose administration twice-daily (BID) 1 week in healthy adults, two III, multi-center, randomized,...

This clinical trial assessed the activity of reproxalap, a novel reactive aldehyde species modulator, and estimated clinically relevant thresholds for changes in ocular itching redness an allergic conjunctivitis field trial.This was randomized, double-masked, vehicle-controlled phase 2 trial. Patients with ragweed-associated were over 28 days environmental setting approximately four doses per day either 0.25% 0.5% or vehicle. recorded itching, redness, tearing, eyelid swelling scores (each...

Background: A new formulation of olopatadine hydrochloride ophthalmic solution (olopatadine 0.2%) was evaluated in two separate, randomized, placebo-controlled, double-masked, hybrid environmental studies intended to determine efficacy and safety subjects with histories seasonal allergic conjunctivitis or rhinoconjunctivitis.Design methods: In these 10- 12-week trials (conducted April–August 2003 July–December 2001, respectively), assessed their ocular signs symptoms. Additionally, the...

Purpose: To compare alcaftadine and olopatadine ophthalmic solutions, vehicle for preventing allergen-mediated conjunctivitis in Japanese subjects. Methods: cedar pollen-sensitive subjects were randomized to 0.25%, 0.1%, or vehicle. Ocular itching was assessed at 3, 5 (primary outcome), 7, 15 min post-conjunctival allergen challenge (CAC) conjunctival hyperemia (secondary 20 post-CAC. Adverse events monitored. Results: Overall, 240 randomized. Alcaftadine 0.25% (challenged 8 h post-dose)...

The purpose of these Phase III studies was to evaluate the efficacy and safety cetirizine ophthalmic solution 0.24% compared with vehicle in treatment allergen-induced conjunctivitis using Ora conjunctival allergen challenge (CAC)® model.The single-center (Study 1) multi-center 2), double-masked, randomized, vehicle-controlled, parallel group, CAC were conducted over ~5 weeks four study visits. design only differed entry criteria: Study 2 required more severe allergic symptoms. Subjects...