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

Fovea Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Allergic Conjunctivitis

Treatments: Drug: Prednisolone Acetate 1% (Pred Forte®); Drug: Prednisolone Acetate 0.12% (Pred Mild®); Drug: FOV1101-00; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00833495

08-003-27

Details and patient eligibility

About

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

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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155 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®)

Treatment:

Drug: FOV1101-00

Drug: Prednisolone Acetate 0.12% (Pred Mild®)

2

Experimental group

Description:

FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®)

Treatment:

Drug: FOV1101-00

Drug: Prednisolone Acetate 0.12% (Pred Mild®)

3

Experimental group

Description:

Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®)

Treatment:

Drug: Placebo

Drug: Prednisolone Acetate 1% (Pred Forte®)

4

Placebo Comparator group

Description:

Vehicle of FOV1101-00 and vehicle of FOV1101-00

Treatment:

Drug: Placebo