Study Evaluating the Efficacy of Administration of Cyclosporine (Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Allergic Conjunctivitis

A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Administration of FOV1101-00 (Cyclosporine Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle in Patients With Mild Ongoing Ocular Allergic Inflammation

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01120132

Enrollment

716

Registered

2010-05-10

Start date

2010-05-31

Completion date

2010-08-31

Last updated

2012-03-09

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

Conditions

Allergic Conjunctivitis

Brief summary

The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.

Interventions

DRUGCsA high dose

Solution of Cyclosporine (high dose) administered during 28 days

DRUGCsA low dose

Solution of Cyclosporine (low dose) administered during 28 days

DRUGPA

Suspension of Prednisolone Acetate administered during 28 days

DRUGPlacebo

Placebo solution administered during 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* history of ocular allergies and a positive skin test reaction to perennial allergens within the past 24 months and a history of chronic eye irritation * visual acuity score ≥ 0.60 (EDTS) * negative urine pregnancy test for female patients, and use of adequate birth control throughout the study period.

Exclusion criteria

* active ocular infection; preauricular lymphadenopathy or ocular condition that could affect study; glaucoma or abnormal intraocular pressure; ocular surgery within past 3 months; history of asthma, pregnancy or nursing * contraindications or known allergies to the study drug(s)

Design outcomes

Primary

Measure	Time frame	Description
Diary assessment of signs and symptoms of ocular allergy	During the 28 days of treatment	Patient-reported ocular itching and redness

Secondary

Measure	Time frame	Description
Diary and office assessments of various ocular and nasal allergy signs and symptoms	During 28 days of treatment	Patient-reported ocular itching and redness, lid swelling, tearing and nasal itching Investigator assessments of ocular redness and chemosis
Safety	During the 28 days of treatment	Ocular tolerance and adverse events

Countries

United States

Outcome results

None listed

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