Skip to main content
OpenTrials
Completed

NCT Number: NCT01319773

Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

This study will evaluate the safety, tolerability and pharmacokinetics of two formulations of cyclosporine ophthalmic emulsion in healthy adults (parallel-group phase). The parallel-group phase will be followed by a paired-eye phase which will evaluate the safety and tolerability of two formulations of cyclosporine ophthalmic emulsion compared with cyclosporine ophthalmic emulsion (RESTASIS®) in patients with dry eye.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Newport Beach, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Parallel-Group Phase:

  • Weigh at least 110 lbs
  • 18 to 45 years old

Paired-Eye Phase:

  • Dry eye disease in both eyes

Exclusion criteria

Parallel-Group Phase:

  • Use of nicotine products, any medications, supplements or herbal products or consumption of grapefruit juice within 14 days or anticipated use during the study
  • Has donated blood within 90 days
  • Significant weight change (over 10 lbs) within 60 days
  • Previous use of RESTASIS®

Parallel-Group and Paired-Eye Phases:

  • Anticipated wearing of contact lenses during the study or wearing of contact lenses within 14 days
  • Consumption of alcohol products within 72 hours

Paired-Eye Phase:

  • Previous ocular surgery
  • Use of RESTASIS® within 30 days

Treatment and study plan

cyclosporine ophthalmic emulsion Formulation A

Drug

One drop of cyclosporine ophthalmic emulsion Formulation A administered to each eye twice daily for 2 days and once in the morning of Day 3.

cyclosporine ophthalmic emulsion Formulation B

Drug

One drop of cyclosporine ophthalmic emulsion Formulation B administered to each eye twice daily for 2 days and once in the morning of Day 3.

cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%

Drug

One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.

Other names: RESTASIS®

cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%

Drug

One drop of cyclosporine ophthalmic emulsion Formulation B administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.

Other names: RESTASIS®

cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B

Drug

One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion Formulation B administered to the opposite eye, twice daily for 1 day.

Primary outcomes

  1. Concentration of Cyclosporine Measured in Blood at Day 1 in the Parallel-Group Phase (PGP)

    Time frame: Day 1

    Concentration of cyclosporine measured in blood at Day 1 of the parallel-group phase (PGP). Blood samples were collected up to 3 hours post-dose and concentrations of cyclosporine were measured.

Secondary outcomes

  1. Number of Subjects Who Reported Ocular Symptoms During the Parallel-Group Phase (PGP)

    Time frame: 3 Days

    Number of subjects who reported ocular symptoms of any severity during the parallel-group phase (PGP) of the study. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild,+1=mild, +2=moderate, and +3=severe).

  2. Number of Eyes With Ocular Symptoms Post-Dose During the Paired-Eye Phase (PEP) at Day 1

    Time frame: Day 1

    Number of eyes with ocular symptoms of any severity, post-dose in the paired-eye phase (PEP) at Day 1. Subjects evaluated the presence and severity of ocular symptoms in each eye. The severity of each symptom (blurring, foreign body sensation, pain, burning/stinging, tearing, and itching) were recorded on a 5-point scale (0=none, +0.5=very mild, +1=mild, +2=moderate, and +3=severe).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 22, 2011
Registry last updated
Sep 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.