A Methodology Development Environmental Clinical Trial of Reproxalap in Subjects With Seasonal Allergic Conjunctivitis
Status: | Recruiting |
---|---|
Conditions: | Allergy, Ocular |
Therapuetic Areas: | Ophthalmology, Otolaryngology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/3/2019 |
Start Date: | September 8, 2018 |
End Date: | February 2019 |
Contact: | Bill Cavanagh |
Email: | bcavanagh@aldeyra.com |
Phone: | 781-761-4904 |
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology Development Environmental Clinical Trial With Reproxalap Ophthalmic Solutions (0.25% and 0.5%) in Subjects With Seasonal Allergic Conjunctivitis
A Multi-Center, Double-Masked, Randomized, Parallel-Group, Vehicle-Controlled, Methodology
Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and
0.5%) in Subjects with Seasonal Allergic Conjunctivitis.
Development Environmental Clinical Trial with Reproxalap Ophthalmic Solutions (0.25% and
0.5%) in Subjects with Seasonal Allergic Conjunctivitis.
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
ragweed pollen as confirmed by the allergic skin test given to the subject within 24
months of the subject's Visit 1
- 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 any of the investigational
product medication or 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 months prior to Visit 1, or during
the trial, or a history of refractive surgery six months prior to Visit 1, or have
systemic surgery planned during the clinical trial or within 30 days after;
- have a known history of retinal detachment, diabetic retinopathy, or active retinal
disease
- have an active ocular infection (bacterial, viral or fungal), active uveitis, or
positive history of an ocular herpetic infection at any visit;
- be a female who is currently pregnant, planning a pregnancy, or lactating
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