NCT01120132

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
716

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2010

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

First Submitted

Initial submission to the registry

April 29, 2010

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 10, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

3 months

First QC Date

April 29, 2010

Last Update Submit

March 8, 2012

Conditions

Allergic Conjunctivitis

Outcome Measures

Primary Outcomes (1)

  • Diary assessment of signs and symptoms of ocular allergy

    Patient-reported ocular itching and redness

    During the 28 days of treatment

Secondary Outcomes (2)

  • Diary and office assessments of various ocular and nasal allergy signs and symptoms

    During 28 days of treatment

  • Safety

    During the 28 days of treatment

Study Arms (6)

Cyclosporine low dose , Prednisolone Acetate

EXPERIMENTAL

Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate

Drug: CsA low doseDrug: PA

Cyclosporine high dose, Prednisolone Acetate

EXPERIMENTAL

Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate

Drug: CsA high doseDrug: PA

Cyclosporine high dose

EXPERIMENTAL

Administration of a solution of Cyclosporine (high dose) and Placebo

Drug: CsA high doseDrug: Placebo

Cyclosporine low dose

EXPERIMENTAL

Administration of a solution of Cyclosporine (low dose) and Placebo

Drug: CsA low doseDrug: Placebo

Prednisolone Acetate

ACTIVE COMPARATOR

Administration of a suspension of Prednisolone Acetate and Placebo

Drug: PA

Placebo

PLACEBO COMPARATOR

Administration of Placebo

Drug: Placebo

Interventions

CsA high doseDRUG

Solution of Cyclosporine (high dose) administered during 28 days

Cyclosporine high doseCyclosporine high dose, Prednisolone Acetate
CsA low doseDRUG

Solution of Cyclosporine (low dose) administered during 28 days

Cyclosporine low doseCyclosporine low dose , Prednisolone Acetate
PADRUG

Suspension of Prednisolone Acetate administered during 28 days

Cyclosporine high dose, Prednisolone AcetateCyclosporine low dose , Prednisolone AcetatePrednisolone Acetate
PlaceboDRUG

Placebo solution administered during 28 days

Cyclosporine high doseCyclosporine low dosePlacebo

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ORA

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Marie-Louise Jacques, MD MBA

    Fovea Pharmaceuticals SA

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 29, 2010

First Posted

May 10, 2010

Study Start

May 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

US(1)