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A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis

Primary Purpose

Allergic Conjunctivitis, Seasonal Allergies

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
NS2 Ophthalmic Drops (0.5%)
NS2 Ophthalmic Drops Vehicle (0.0%)
Sponsored by
Aldeyra Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring allergic conjunctivitis, seasonal allergies, ragweed allergy, grass allergy, tree allergy, NS2, Aldeyra

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Graded conjunctival redness in at least one region (nasal or temporal) in each eye at any one time point (not necessarily the same time point) post-CAPT (Conjunctival Allergen Provocation Test) of >2
  • Graded ocular itching at any one time point
  • Visual acuity of at least 20/50 in each eye
  • At least 2 year history of moderate to severe allergic conjunctivitis.
  • Positive skin prick test to ragweed, grass and/or tree pollen within one year of Screening Visit (Visit 1).
  • Ability to avoid any topical or systemic ocular medications during the entire study period.

Exclusion Criteria:

  • Subjects must not have an ocular itching score >0 or a conjunctival redness score >1 prior to CAPT in either eye in any region (nasal or temporal) at Visits 2-4. I
  • History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year.
  • Ocular surgery, including laser procedures, within the past 12 months of Visit 1.
  • Use of glaucoma medications, antibiotics, antivirals, or topical cyclosporine within 1 month of the screening visit.
  • History of dry eye syndrome, blepharitis, herpes simplex keratitis or herpes zoster keratitis.
  • History of uveitis in the past 3 years.
  • Presence of any ocular infection or active ocular inflammation (e.g. follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to start of study (Visit 1).
  • History of moderate to severe asthma or allergy induced asthma to the allergen that will be used in CAPT.
  • Use of oral corticosteroids within 30 days of screening and throughout the study period; use of intranasal or inhaled corticosteroids within 14 days of screening and throughout the study period.
  • Use of antihistamines (ocular, nasal, topical or oral) within 7 days prior to screening (Visit 1) and throughout the study period. Non-medicated artificial tears are allowed up to 72 hours before screening (Visit 1) and throughout the study period.

Sites / Locations

  • Inflamax Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

NS2 Ophthalmic Drops (0.5%)

NS2 Ophthalmic Drops Vehicle (0.0%)

Arm Description

NS2 Ophthalmic Drops (0.5%)

NS2 Ophthalmic Drops Vehicle (0.0%) control

Outcomes

Primary Outcome Measures

Mean change from baseline in Ocular itching scores.
Mean change from baseline in ocular itching. Scores are entered as 0 (none), 1 (trace), 2 (mild), 3 (moderate), 4 (severe). Ocular itching will be collected through 180 minutes following allergen challenge at Visits 3, 3b, 4, 5, 6, and 7.
Mean change from baseline in Conjunctival redness scores based on modified validated bulbar redness TM descriptive and photgraphic scale.
Mean change from baseline in conjunctival redness. Scores are entered as 0 (none), 1 (trace), 2 (mild), 3 (moderate), 4 (extremely severe). Scores are entered as 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (extremely severe). Conjunctival redness will be collected through180 minutes following allergen challenge at Visits 3, 3b, 4, 5, 6, and 7.
Mean change from baseline in Lid swelling scores.
Mean change from baseline in lid swelling. Scores are entered as 0 (none), 1 (trace), 2 (mild), 3 (moderate), 4 (extremely severe). Scores are entered as 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (extremely severe). Lid swelling will be collected through180 minutes following allergen challenge at Visits 3, 3b, 4, 5, 6, and 7.
Mean change from baseline in Ocular tearing scores.
Mean change from baseline in ocular tearing scores. Scores are entered as 0 (none), 1 (mild), 2 (moderate), 3 (severe). Ocular tearing will be collected through 180 minutes following allergen challenge at Visits 3, 3b, 4, 5, 6, and 7.
Change from baseline in abnormal slit lamp examination findings.Grade of lids, tear film, conjunctiva, sclera, cornea, iris, anterior/posterior chamber and lens will be reported.
Evaluate for presence of disease compared to baseline and descriptive statistics will be reported for the number of eyes with a change from baseline . A slit lamp exam evaluates the conjunctiva, cornea and anterior chamber of the eye with the aid of a slit lamp.
Number of eyes with undilated fundoscopy changes from baseline.
Evaluate presence of inflammation, disease and risk of glaucoma or retinal detachment and visual loss from baseline. Descriptive statistics will be reported for changes to the vitreous, retina, macula, blood vessels and the optic nerve.
Change from baseline in Intraocular pressure measurement (IOP).
IOP will be measured and recorded in mmHg and the change from baseline will be evaluated.
Frequency of treatment emergent adverse events (AEs) as a measure of safety and tolerability.
Treatment emergent adverse events will be summarized for all causality AEs and treatment related AEs. Treatment emergent AEs are those that first occured or worsened after the first dose of study medication.
Visual acuity measured by a standardized eye chart.
Change from baseline in visual acuity and descriptive statistics will be reported.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2015
Last Updated
May 25, 2016
Sponsor
Aldeyra Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02578914
Brief Title
A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis
Official Title
A Randomized, Parallel, Single-Center, Double-Masked, Vehicle-Controlled Phase II Study to Evaluate the Activity of NS2 Ophthalmic Solution in Subjects With Allergic Conjunctivitis Using the Conjunctival Allergen Provocation Test (CAPT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a randomized, parallel, single center, double masked, vehicle controlled study. The purpose of this study is to determine the activity and safety of NS2 in patients with grass, tree or ragweed-pollen induced seasonal allergic conjunctivitis . Subjects will be randomized 1:1 to receive multiple doses of NS2 Ophthalmic Drops (0.5%) or NS2 Ophthalmic Drops Vehicle (0.0%). Free aldehydes are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2, a small molecule aldehyde trap, is being evaluated to determine whether it may decrease inflammation by lowering aldehyde levels.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis, Seasonal Allergies
Keywords
allergic conjunctivitis, seasonal allergies, ragweed allergy, grass allergy, tree allergy, NS2, Aldeyra

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NS2 Ophthalmic Drops (0.5%)
Arm Type
Experimental
Arm Description
NS2 Ophthalmic Drops (0.5%)
Arm Title
NS2 Ophthalmic Drops Vehicle (0.0%)
Arm Type
Sham Comparator
Arm Description
NS2 Ophthalmic Drops Vehicle (0.0%) control
Intervention Type
Drug
Intervention Name(s)
NS2 Ophthalmic Drops (0.5%)
Intervention Type
Drug
Intervention Name(s)
NS2 Ophthalmic Drops Vehicle (0.0%)
Primary Outcome Measure Information:
Title
Mean change from baseline in Ocular itching scores.
Description
Mean change from baseline in ocular itching. Scores are entered as 0 (none), 1 (trace), 2 (mild), 3 (moderate), 4 (severe). Ocular itching will be collected through 180 minutes following allergen challenge at Visits 3, 3b, 4, 5, 6, and 7.
Time Frame
(up to) Day 30 (V2), Day 37 (V3), Day 44 (V3b), Day 51 First Dose (V4), Day 65 (V5), Day 66 (V6), Day 67 (V7)
Title
Mean change from baseline in Conjunctival redness scores based on modified validated bulbar redness TM descriptive and photgraphic scale.
Description
Mean change from baseline in conjunctival redness. Scores are entered as 0 (none), 1 (trace), 2 (mild), 3 (moderate), 4 (extremely severe). Scores are entered as 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (extremely severe). Conjunctival redness will be collected through180 minutes following allergen challenge at Visits 3, 3b, 4, 5, 6, and 7.
Time Frame
(up to) Day 30 (V2), Day 37 (V3), Day 44 (V3b), Day 51 First Dose (V4), Day 65 (V5), Day 66 (V6), Day 67 (V7)
Title
Mean change from baseline in Lid swelling scores.
Description
Mean change from baseline in lid swelling. Scores are entered as 0 (none), 1 (trace), 2 (mild), 3 (moderate), 4 (extremely severe). Scores are entered as 0 (none), 1 (mild), 2 (moderate), 3 (severe), 4 (extremely severe). Lid swelling will be collected through180 minutes following allergen challenge at Visits 3, 3b, 4, 5, 6, and 7.
Time Frame
(up to) Day 30 (V2), Day 37 (V3), Day 44 (V3b), Day 51 First Dose (V4), Day 65 (V5), Day 66 (V6), Day 67 (V7)
Title
Mean change from baseline in Ocular tearing scores.
Description
Mean change from baseline in ocular tearing scores. Scores are entered as 0 (none), 1 (mild), 2 (moderate), 3 (severe). Ocular tearing will be collected through 180 minutes following allergen challenge at Visits 3, 3b, 4, 5, 6, and 7.
Time Frame
(up to) Day 30 (V2), Day 37 (V3), Day 44 (V3b), Day 51 First Dose (V4), Day 65 (V5), Day 66 (V6), Day 67 (V7)
Title
Change from baseline in abnormal slit lamp examination findings.Grade of lids, tear film, conjunctiva, sclera, cornea, iris, anterior/posterior chamber and lens will be reported.
Description
Evaluate for presence of disease compared to baseline and descriptive statistics will be reported for the number of eyes with a change from baseline . A slit lamp exam evaluates the conjunctiva, cornea and anterior chamber of the eye with the aid of a slit lamp.
Time Frame
Day 0 (screening), (up to) Day 30 (V2), Day 37 (V3), Day 44 (V3b), Day 51 First Dose (V4), Day 65 (V5), Day 66 (V6), Day 67 (V7)
Title
Number of eyes with undilated fundoscopy changes from baseline.
Description
Evaluate presence of inflammation, disease and risk of glaucoma or retinal detachment and visual loss from baseline. Descriptive statistics will be reported for changes to the vitreous, retina, macula, blood vessels and the optic nerve.
Time Frame
Day 0 (screening),Day 67 (V7)
Title
Change from baseline in Intraocular pressure measurement (IOP).
Description
IOP will be measured and recorded in mmHg and the change from baseline will be evaluated.
Time Frame
Day 0 (screening),Day 67 (V7)
Title
Frequency of treatment emergent adverse events (AEs) as a measure of safety and tolerability.
Description
Treatment emergent adverse events will be summarized for all causality AEs and treatment related AEs. Treatment emergent AEs are those that first occured or worsened after the first dose of study medication.
Time Frame
Day 0 (screening), (up to) Day 30 (V2), Day 37 (V3), Day 44 (V3b), Day 51 First Dose (V4), Day 65 (V5), Day 66 (V6), Day 67 (V7)
Title
Visual acuity measured by a standardized eye chart.
Description
Change from baseline in visual acuity and descriptive statistics will be reported.
Time Frame
Day 0 (screening), (up to) Day 30 (V2), Day 37 (V3), Day 44 (V3b), Day 51 First Dose (V4), Day 65 (V5), Day 66 (V6), Day 67 (V7)
Other Pre-specified Outcome Measures:
Title
Cytokine expression.
Description
Mean change from baseline in cytokine expression.
Time Frame
Day 37 (V3), Day 44 (V3b), Day 37 (V3), Day 44 (V3b)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Graded conjunctival redness in at least one region (nasal or temporal) in each eye at any one time point (not necessarily the same time point) post-CAPT (Conjunctival Allergen Provocation Test) of >2 Graded ocular itching at any one time point Visual acuity of at least 20/50 in each eye At least 2 year history of moderate to severe allergic conjunctivitis. Positive skin prick test to ragweed, grass and/or tree pollen within one year of Screening Visit (Visit 1). Ability to avoid any topical or systemic ocular medications during the entire study period. Exclusion Criteria: Subjects must not have an ocular itching score >0 or a conjunctival redness score >1 prior to CAPT in either eye in any region (nasal or temporal) at Visits 2-4. I History of glaucoma, or Intraocular Pressure (IOP) over 25mmHg at the screening visit, or a history of elevated IOP within the past 1 year. Ocular surgery, including laser procedures, within the past 12 months of Visit 1. Use of glaucoma medications, antibiotics, antivirals, or topical cyclosporine within 1 month of the screening visit. History of dry eye syndrome, blepharitis, herpes simplex keratitis or herpes zoster keratitis. History of uveitis in the past 3 years. Presence of any ocular infection or active ocular inflammation (e.g. follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to start of study (Visit 1). History of moderate to severe asthma or allergy induced asthma to the allergen that will be used in CAPT. Use of oral corticosteroids within 30 days of screening and throughout the study period; use of intranasal or inhaled corticosteroids within 14 days of screening and throughout the study period. Use of antihistamines (ocular, nasal, topical or oral) within 7 days prior to screening (Visit 1) and throughout the study period. Non-medicated artificial tears are allowed up to 72 hours before screening (Visit 1) and throughout the study period.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Couroux
Organizational Affiliation
Inflamax Research Incorporated
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inflamax Research Inc.
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1A4
Country
Canada

12. IPD Sharing Statement

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A Safety and Activity Study of NS2 in Subjects With Allergic Conjunctivitis

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