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Completed

NCT Number: NCT03012165

A Study of ADX-102 in Subjects With Allergic Conjunctivitis

A Multi-Center, Double-Masked, Randomized, Vehicle-Controlled, Phase 2b Evaluation of the Onset and Duration of ADX-102 Ophthalmic Drops (0.5% and 0.1%) Compared to Vehicle of ADX-102 Ophthalmic Drops in the Conjunctival Allergen Challenge (Ora-CAC®) Model of Acute Allergic Conjunctivitis.

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Key information

Conditions

Conjunctivitis, Allergic Conjunctival Diseases Conjunctivitis Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eye Care Centers Management, Morrow, Georgia, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • be at least 18 years of age of either gender and any race
  • have a positive history of ocular allergies and a positive skin test reaction to a seasonal (grasses, ragweed, and/or trees) or perennial allergen (cat dander, dog dander, dust mites, cockroach) as confirmed by an allergic skin test within the past 24 months
  • have a calculated visual acuity of 0.7 logMAR or better in each eye as measured using an ETDRS chart

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, pterygium or a diagnosis of dry eye)
  • have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past six (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
  • be a female who is currently pregnant, planning a pregnancy, lactating, not using a medically acceptable form of birth control throughout the study duration and for 14 days prior to the installation of investigational product, or has a positive urine pregnancy test at Visit 1

Treatment and study plan

ADX-102 Ophthalmic Drops (0.5%)

Drug

ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.

ADX-102 Ophthalmic Drops (0.1%)

Drug

ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.

Vehicle of ADX-102 Ophthalmic Drops

Drug

Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.

Primary outcomes

  1. Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.

    Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.

    Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

  2. Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.

    Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.

    Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

  3. Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.

    Time frame: Efficacy assessment period (Day 1 through Day 15), Day 15 reported.

    Ocular itching using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale (0 = least, 4= most), where a higher score is indicative of a worse outcome. The intervention was administered bilaterally.

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Collaborators

  • ORA, Inc.

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 6, 2017
Registry last updated
Jan 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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