A Study of ADX-102 in Subjects With Allergic Conjunctivitis

Conjunctivitis, Allergic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012165
• Other study ID #: ADX-102-AC-004
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: May 2017

Study information

• Verified date: December 2022
• Source: Aldeyra Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• ADX-102 Ophthalmic Drops (0.5%)
ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
• ADX-102 Ophthalmic Drops (0.1%)
ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
• Vehicle of ADX-102 Ophthalmic Drops
Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.

Locations

Country	Name	City	State
United States	Silverstein Eye Centers	Kansas City	Missouri
United States	Apex Eye Clinical Research	Mason	Ohio
United States	Total Eye Care	Memphis	Tennessee
United States	Eye Care Centers Management	Morrow	Georgia
United States	Philadelphia Eye Associates	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Aldeyra Therapeutics, Inc.	ORA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Itching Evaluated by the Subject at 10(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.	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.	Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Primary	Ocular Itching Evaluated by the Subject at 15(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.	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.	Efficacy assessment period (Day 1 through Day 15), Day 15 reported.
Primary	Ocular Itching Evaluated by the Subject at 20(±1) Minutes Post the Ora Calibra® Conjunctival Allergen Challenge at Day 15.	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.	Efficacy assessment period (Day 1 through Day 15), Day 15 reported.