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Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis

A Multi-Center, Double-Masked, Randomized, Phase 2 Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model

NCT02978183•Noveome Biotherapeutics, formerly Stemnion

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy of ST266 ophthalmic drops compared to placebo for the treatment of the signs and symptoms of allergic conjunctivitis.

Detailed Description

The study is a multi-center, double-masked, randomized, placebo-controlled, modified conjunctival allergen challenge (CAC) model. The primary endpoints of ocular itching and conjunctival redness will be evaluated at the subject's final visit. Subjects who meet inclusion criteria will be randomized to one of two treatment groups (1:1). Randomization will be stratified by average post-CAC itching scores at baseline. Subjects will be evaluated at baseline and on Days 6, 7 and 8.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•be at least 18 years of age of either gender and any race;
•provide written informed consent and sign the HIPAA form;
•be willing and able to follow all instructions and attend all study visits; have a positive history of ocular allergies and a positive skin test reaction to a seasonal AND perennial allergen as confirmed by an allergic skin test;
•be able and willing to avoid all disallowed medication for the appropriate washout period and during the study;
•be able and willing to discontinue wearing contact lenses for at least 72 hours prior to and during the study trial period;
•(for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and at the study exit; must not be lactating; and must agree to use a medically acceptable form of birth control throughout the study duration and for at least 14 days prior to instillation of investigational product). Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
•have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart;
•have a positive post-CAC reaction;
•have a positive post-CAC reaction in two out of the first three time points;
•be able to self-administer eye drops satisfactorily or have a caregiver at home routinely available for this purpose.

Exclusion Criteria

•have known contraindications or sensitivities to the use of the investigational product or any of its components;
•have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, or pterygium);
•have had ocular surgical intervention within 3 months prior to initiating the study or during the study and/or a history of refractive surgery within the past 6 months;
•have a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
•have the presence of an active ocular infection (bacterial, viral or fungal) or positive history of an ocular herpetic infection at any visit;
•use any of the disallowed medications during the period indicated prior to and during the study;
•have any significant illness (e.g. any autoimmune disease requiring therapy, severe cardiovascular disease \[including arrhythmias\]) the investigator feels could be expected to interfere with the subject's health or with the study parameters and/or put the subject at any unnecessary risk (includes but is not limited to: poorly controlled hypertension or poorly controlled diabetes, a history of status asthmaticus, organ transplants, a known history of persistent moderate or severe asthma, or a known history of moderate to severe allergic asthmatic reactions to any of the study allergens);
•manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at the screening visit;
•have planned surgery (ocular or systemic) during the trial period or within 30 days after;
•have used an investigational drug or medical device within 30 days of the study or be concurrently enrolled in another investigational product trial;
+2 more criteria

Locations (2)

Andover, Massachusetts, United States

Memphis, Tennessee, United States

Key Dates

Start Date

December 1, 2016

Primary Completion Date

February 1, 2017

Completion Date

November 1, 2017

Last Updated

April 10, 2023

Enrollment

ACTUAL participants

Conditions

Allergic Conjunctivitis

Interventions

ST266

BIOLOGICAL

Saline (0.9% NaCl)

DRUG

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

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Allergic Conjunctivitis

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ACTIVE_NOT_RECRUITING

Tyrosine Allergoid Paediatric and Adult Study

NCT05186025

Allergic Rhinitis Due to PollenAllergic Conjunctivitis+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Effectiveness of ST266 Ophthalmic Drops Compared to Placebo to Treat Allergic Conjunctivitis

Inclusion Criteria

Exclusion Criteria

The Role of Vitamin D in Corneal Epithelial Barrier Function, Ocular Microbiome, Ocular Inflammation, and Visual Acuity of Children With Allergic Conjunctivitis

Tyrosine Allergoid Paediatric and Adult Study

Documentation of Efficacy of Intralymphatic Allergen Immunotherapy

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