CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 44 enrolled
Drug / intervention
cyclosporine ophthalmic emulsion Formulation A +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01319773
NCT01319773Phase 1Completed
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Study of Two Formulations of Cyclosporine Ophthalmic Emulsion in Healthy Volunteers and in Patients With Dry Eye

Allergan·interventional·Posted Mar 22, 2011·Updated Sep 7, 2015

In Brief

A Phase 1 clinical trial evaluating cyclosporine ophthalmic emulsion Formulation A, cyclosporine ophthalmic emulsion Formulation B, and 3 other interventions for Dry Eye Syndromes. Completed, enrolled 44 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndromes
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2011
Enrollment StartNov 1, 2010
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 15.3 years ago

Interventions

cyclosporine ophthalmic emulsion Formulation Adrug

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 Bdrug

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.

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.

cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation Bdrug

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.