Evaluation of Efficacy of Ophthalmic Solution in Induced Acute Allergic Conjunctivitis

A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Evaluation of the Onset and Duration of Action of R89674 0.25% Ophthalmic Solution in Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00241319

Enrollment

150

Registered

2005-10-18

Start date

2005-10-31

Completion date

Unknown

Last updated

2011-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Conjunctivitis

Keywords

ocular, allergic conjunctivitis, ophthalmic

Brief summary

The purpose of this study is to establish the efficacy of R89674 0.25% ophthalmic solution compared with placebo in alleviating the signs and symptoms of conjunctival allergen challenge-induced allergic conjunctivitis

Interventions

DRUGR89674 (generic name not yet established)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

10 Years to No maximum

Healthy volunteers

Inclusion criteria

* history of ocular allergies and a positive skin test reaction to cat hair, * cat dander, grasses, ragweed, and/or trees within the past 24 months; * calculated best-corrected visual acuity of 0.6 logMar or better in each eye; - positive bilateral conjunctival allergy challenge reaction

Exclusion criteria

* narrow angle glaucoma, * clinically significant blepharitis, follicular conjunctivitis, iritis * pterygium or diagnosis of dry eye * ocular surgical intervention within 3 months * history of refractive surgery within 6 months * known history of retinal detachment, diabetic retinopathy, or progressive retinal disease * presence of active ocular infection positive history of an ocular herpetic infection * preauricular lymphadenopath manifest signs or symptoms of clinically active allergic conjunctivitis

Design outcomes

Primary

Measure	Time frame
Ocular itching and conjunctival redness post challenge	—

Secondary

Measure	Time frame
Ciliary and episcieral redness; chemosis; lid swelling; tearing; ocular mucous discharge; and nasal symptoms. All measured postchallenge	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026