Evaluation of Efficacy of Ophthalmic Solution in Seasonal Allergic Conjunctivitis

A Multi-Center, Randomized, Double-Masked Parallel Group Study Evaluating the Efficacy, Safety, and QOL of R89674 0.25% Ophthalmic Solution Compared to Vehicle or an Active Control in a Modified Model of Environmental Seasonal Allergic Conjunctivitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00364091

Enrollment

365

Registered

2006-08-15

Start date

2006-08-31

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

allergic conjunctivitis, ophthalmology, multicenter, controlled

Brief summary

The purpose of this summary is to evaluate the efficacy and safety of R89674 0.025% ophthalmic solution compared with placebo or an active control in subjects with seasonal allergic conjunctivitis

Interventions

DRUGR89674 0.025% ophthalmic solution

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 positive diagnostic test for ragweed within the past 2 years; * positive bilateral response to ragweed as induced by conjunctival allergen challenge

Exclusion criteria

* ocular infection; * history of retinal detachment, diabetic neuropathy, or any progressive retinal disease; * moderate to severe asthma; * dry eye syndrome; * history of severe, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal or autoimmune disease; * pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Ocular itching and redness scores at defined timepoints	—

Secondary

Measure	Time frame
QOL, severity of chemosis & redness, ocular itching and redness scores at defined timepoints	—

Countries

United States

Outcome results

None listed

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