NCT00833495

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 2, 2009

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

2 months

First QC Date

January 30, 2009

Last Update Submit

March 8, 2012

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Ocular Allergic signs and symptoms Diary Scores

    Between V2 and V3

Secondary Outcomes (1)

  • Various ocular and nasal allergic diary scores

    Between V2 and V3

Study Arms (4)

1

EXPERIMENTAL

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

Drug: Prednisolone Acetate 0.12% (Pred Mild®)Drug: FOV1101-00

2

EXPERIMENTAL

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

Drug: Prednisolone Acetate 0.12% (Pred Mild®)Drug: FOV1101-00

3

EXPERIMENTAL

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

Drug: Prednisolone Acetate 1% (Pred Forte®)Drug: Placebo

4

PLACEBO COMPARATOR

Vehicle of FOV1101-00 and vehicle of FOV1101-00

Drug: Placebo

Interventions

Prednisolone Acetate 0.12% (Pred Mild®)DRUG

Indicated for the treatment of mild to moderate noninfectious allergic and inflammatory disorders of the lid, conjunctiva, cornea, and sclera (including chemical and thermal burns). Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary.

12
FOV1101-00DRUG

This investigational drug is a low dose cyclosporine (also known as cyclosporine A; CsA) formulation for topical ocular administration. FOV1101-00 is presented as a solution for topical ophthalmic administration in two strengths, concentration 1 or concentration 2 w/v cyclosporine in citrate buffered aqueous vehicle. Application is intended as four times per day.

12
Prednisolone Acetate 1% (Pred Forte®)DRUG

PRED FORTE® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. Instill one to two drops into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue therapy prematurely.

3
PlaceboDRUG

The vehicle is an eye drop that contains only the inactive ingredients of FOV1101-00.

34

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ora

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

prednisolone acetateMethylprednisolone

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Jean-Philippe Combal, PharmD

    Fovea Pharmaceuticals SA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2009

First Posted

February 2, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

US(1)