Evaluation of Efficacy of Coadministration of FOV1101-00 and Prednisolone Acetate in Patients With Mild Ongoing Ocular Allergic Inflammation

Phase 2

Completed

• Conditions: Allergic Conjunctivitis
• Interventions: Drug: Prednisolone Acetate 1% (Pred Forte®); Drug: Prednisolone Acetate 0.12% (Pred Mild®); Drug: Placebo; Drug: FOV1101-00

• Registration Number: NCT00833495
• Lead Sponsor: Fovea Pharmaceuticals SA

Brief Summary

This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Study subjects will be randomized to one of the following:

* FOV1101-00 concentration 1 and Pred Mild®

* FOV1101-00 concentration 2 and Pred Mild®

* Vehicle of FOV1101-00 and Pred Forte®

* Vehicle of FOV1101-00 and Vehicle of FOV1101-00

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-01-30
• Study First Submitted QC: 2009-01-30
• Study First Posted: 2009-02-02
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Disposition First Submitted: 2010-09-28
• Disposition First Submitted QC: 2010-09-28
• Disposition First Posted: 2010-10-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-08
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

• history of ocular allergies and a positive skin test reaction to allergens within the past 24 months and a history of chronic eye irritation;

Exclusion Criteria

• active ocular infection; clinically significant blepharitis; follicular conjunctivitis; iritis; any type of glaucoma; ocular surgery within past 3 months; pregnancy or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
3	Prednisolone Acetate 1% (Pred Forte®)	Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®)
1	Prednisolone Acetate 0.12% (Pred Mild®)	FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®)
2	Prednisolone Acetate 0.12% (Pred Mild®)	FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®)
4	Placebo	Vehicle of FOV1101-00 and vehicle of FOV1101-00
3	Placebo	Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®)
1	FOV1101-00	FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®)
2	FOV1101-00	FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®)

Primary Outcome Measures

Name	Time	Method
Ocular Allergic signs and symptoms Diary Scores	Between V2 and V3

Secondary Outcome Measures

Name	Time	Method
Various ocular and nasal allergic diary scores	Between V2 and V3

Trial Locations

Locations (1)

Ora; 🇺🇸 Andover, Massachusetts, United States