The INVIGORATE Trial: A Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.

A

Aldeyra Therapeutics

Status and phase

Completed
Phase 3

Conditions

Allergic Conjunctivitis

Treatments

Drug: Reproxalap Ophthalmic Solution (0.25%)
Drug: Vehicle Ophthalmic Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT04207736
ADX-102-AC-017

Details and patient eligibility

About

The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Subjects With Seasonal Allergic Conjunctivitis.

Full description

The INVIGORATE Trial: A Randomized, Double-masked, Crossover Design, Vehicle-controlled Phase 3 Clinical Trial to Assess the Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC).

Enrollment

95 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • be at least 18 years of age of either gender and any race
  • have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on principal investigator's judgement
  • have a positive skin prick test to ragweed pollen within the past year of screening

Exclusion criteria

  • known contraindication or hypersensitivities to any components of the investigational product medication or components
  • history of uveitis, blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
  • presence of any ocular infection (bacterial, viral, or fungal) or active ocular inflammation (e.g., follicular conjunctivitis, allergic conjunctivitis) within 14 days prior to screening
  • presence of any chronic ocular degenerative condition or ocular inflammation that, in the opinion of the investigator, is likely to worsen over the course of the clinical trial;
  • diagnosis of moderate-to-severe pinguecula or pterygium (particularly if it results in chronic erythema), Stevens-Johnson Syndrome, ocular cicatricial pemphigoid, mucous membrane pemphigoid, significant conjunctival scarring, chemical burn, herpetic or neurotrophic keratitis, Cryopyrin Associated Periodic Syndrome (CAPS), or keratoconus
  • woman of childbearing potential who is pregnant or nursing

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

95 participants in 2 patient groups, including a placebo group

Reproxalap Ophthalmic Solution (0.25%)
Active Comparator group
Treatment:
Drug: Reproxalap Ophthalmic Solution (0.25%)
Vehicle Ophthalmic Solution
Placebo Comparator group
Treatment:
Drug: Vehicle Ophthalmic Solution

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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