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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Allergic Conjunctivitis

Intervention / Treatment
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* Biological: ST266
* Drug: Saline (0.9% NaCl)


Participation Criteria
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Eligibility Criteria
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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; be a female who is currently pregnant, planning a pregnancy, or lactating. have cancer or have a history of cancer within the last 5 years.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>1X ST266 dosed 4 times a day for 8 days | Biological: ST266<br>* One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.<br>|
| Placebo Comparator: Group 2<br>Placebo dosed 4 times a day for 8 days | Drug: Saline (0.9% NaCl)<br>* One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Itching | Ocular itching evaluated by the subject. Ocular itching was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less itching. | Day 7 and 8 | 
| Conjunctival Redness | Conjunctival redness evaluated by the investigator. Conjunctival redness was evaluated on a 0-4 scale (with half unit increments allowed). Lower scores indicated less redness. | Day 7 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ciliary Redness | Ciliary redness evaluated by the investigator. Ciliary redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness. | Day 7 and 8 | 
| Episcleral Redness | Episcleral redness evaluated by the investigator. Episcleral redness was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less redness. | Day 7 and 8 | 
| Chemosis | Chemosis evaluated by the investigator. Chemosis was evaluated on a 0-4 scale (with half unit increments allowed). A lower score was indicative of less chemosis. | Day 7 and 8 | 
| Eyelid Swelling | Eyelid swelling evaluated by the subject. Eyelid swelling was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less swelling. | Day 7 and 8 | 
| Tearing/Watery Eyes | Tearing evaluated by the subject. Tearing was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less tearing. | Day 7 and 8 | 
| Rhinorrhea | Rhinorrhea evaluated by the subject. Rhinorrhea was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity. | Day 7 and 8 | 
| Nasal Pruritus | Nasal Pruritus evaluated by the subject. Nasal pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity. | Day 7 and 8 | 
| Ear or Palate Pruritus | Ear or palate pruritus evaluated by the subject. Ear or palate pruritus was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity. | Day 7 and 8 | 
| Nasal Congestion | Nasal congestion evaluated by the subject. Nasal congestion was evaluated on a 0-4 scale in which 0.5 unit increments were not allowed. A lower score was indicative of less severity. | Day 7 and 8 | 
| Nasal Composite Score | A composite score of presence or absence of at least one nasal symptom evaluated by the subject | Day 7 and 8 |