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CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cyclosporine A
Placebo
Sponsored by
Novaliq GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndromes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document
  • Patient-reported history of dry eye in both eyes
  • Current use of over-the-counter and/or prescription eye drops for dry eye symptoms
  • Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

  • Women who are pregnant, nursing or planning a pregnancy
  • Unwillingness to submit a blood pregnancy test at screening and at the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
  • Clinically significant slit-lamp findings or abnormal lid anatomy at screening
  • DED secondary to scarring or ocular or periocular malignancy
  • History of herpetic keratitis
  • Active ocular allergies or ocular allergies that are expected to be active during the study period
  • Ongoing ocular or systemic infection at screening or baseline
  • Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
  • History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A within 6 months prior to screening
  • Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
  • Presence of an uncontrolled systemic disease
  • Presence of a known allergy and/or sensitivity to the study drug or its components

Sites / Locations

  • CYS-002 Investigational Site
  • CYS-002 Investigational Site
  • CYS-002 Investigational Site
  • CYS-002 Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

CyclASol Ophthalmic Solution 1

CyclASol Ophthalmic Solution 2

Placebo Ophthalmic Solution

Restasis

Arm Description

Cyclosporine A solution (dose-level 1) in vehicle

Cyclosporine A solution (dose-level 2) in vehicle

Vehicle only

Cyclosporine A 0.05% ophthalmic emulsion

Outcomes

Primary Outcome Measures

Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days
The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0-3 based on the National Eye Institute scale, where 0 indicates no staining and 3 maximal staining. The total score is the sum of all these regions. The maximum score for each eye is 15.
Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days
The primary analysis and objective of the study was to compare the the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. Furthermore, the open label character could have had an impact on patient reported outcomes. The symptom endpoint was the change from baseline in severity of dryness VAS at Day 113. Dryness severity was rated from 0 to 100%, where 0% corresponds to "no dryness" and 100% corresponds to "maximum dryness".

Secondary Outcome Measures

Full Information

First Posted
November 25, 2015
Last Updated
October 23, 2019
Sponsor
Novaliq GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02617667
Brief Title
CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)
Official Title
A Phase 2, Multi-center, Randomized, Double-masked, Placebo (Vehicle)-Controlled Clinical Study With an Open Label Comparator Arm to Assess the Efficacy, Safety and Tolerability of Topical CyclASol® for Treatment of Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novaliq GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED).
Detailed Description
This phase 2 study explored the safety, efficacy and tolerability of two CyclASol concentrations as one drop twice daily versus vehicle (placebo). In addition to the masked vehicle control arm, an open-label comparator arm consisting of Restasis was included. The study explored a range of signs and symptoms of DED to gain an understanding of the possible treatment effects in comparison to vehicle and estimation of effect sizes. In line with current treatment guidelines, the proposed phase 2 population consisted of patients suffering from moderate to severe DED. The primary treatment comparisons in this study were between the two CyclASol concentrations versus vehicle for the sign variable total corneal fluorescein staining and the symptom variable dryness severity visual analogue scale at day 113. All other comparisons between treatments groups were considered secondary analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CyclASol Ophthalmic Solution 1
Arm Type
Experimental
Arm Description
Cyclosporine A solution (dose-level 1) in vehicle
Arm Title
CyclASol Ophthalmic Solution 2
Arm Type
Experimental
Arm Description
Cyclosporine A solution (dose-level 2) in vehicle
Arm Title
Placebo Ophthalmic Solution
Arm Type
Placebo Comparator
Arm Description
Vehicle only
Arm Title
Restasis
Arm Type
Active Comparator
Arm Description
Cyclosporine A 0.05% ophthalmic emulsion
Intervention Type
Drug
Intervention Name(s)
Cyclosporine A
Other Intervention Name(s)
Ciclosporin, CsA
Intervention Description
topical ocular, eye drops
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Excipient
Intervention Description
topical ocular, eye drops
Primary Outcome Measure Information:
Title
Change From Baseline (Visit 1) in Total Corneal Fluorescein Staining at 113 Days
Description
The primary analysis and objective of the study was to compare the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. The sign endpoint was the change from baseline in total corneal fluorescein staining at day 113. The cornea is divided into five regions: central, superior, inferior, nasal and temporal. Each region is graded from 0-3 based on the National Eye Institute scale, where 0 indicates no staining and 3 maximal staining. The total score is the sum of all these regions. The maximum score for each eye is 15.
Time Frame
Baseline to 113 Days
Title
Change From Baseline (Visit 1) in Dryness Severity Visual Analog Scale (VAS) at 113 Days
Description
The primary analysis and objective of the study was to compare the the two CyclASol groups versus vehicle (all blinded treatment arms) for one sign and one symptom endpoint. The open label active comparator arm was not included in the primary analysis to reduce the number of comparisons. Furthermore, the open label character could have had an impact on patient reported outcomes. The symptom endpoint was the change from baseline in severity of dryness VAS at Day 113. Dryness severity was rated from 0 to 100%, where 0% corresponds to "no dryness" and 100% corresponds to "maximum dryness".
Time Frame
Baseline to 113 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document Patient-reported history of dry eye in both eyes Current use of over-the-counter and/or prescription eye drops for dry eye symptoms Ability and willingness to follow instructions, including participation in all study assessments and visits Exclusion Criteria: Women who are pregnant, nursing or planning a pregnancy Unwillingness to submit a blood pregnancy test at screening and at the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control Clinically significant slit-lamp findings or abnormal lid anatomy at screening DED secondary to scarring or ocular or periocular malignancy History of herpetic keratitis Active ocular allergies or ocular allergies that are expected to be active during the study period Ongoing ocular or systemic infection at screening or baseline Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A within 6 months prior to screening Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period Presence of an uncontrolled systemic disease Presence of a known allergy and/or sensitivity to the study drug or its components
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja Kroesser, Dr.sc.hum.
Organizational Affiliation
Novaliq GmbH
Official's Role
Study Director
Facility Information:
Facility Name
CYS-002 Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
CYS-002 Investigational Site
City
Lewiston
State/Province
Maine
ZIP/Postal Code
04240
Country
United States
Facility Name
CYS-002 Investigational Site
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
CYS-002 Investigational Site
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30703441
Citation
Wirta DL, Torkildsen GL, Moreira HR, Lonsdale JD, Ciolino JB, Jentsch G, Beckert M, Ousler GW, Steven P, Krosser S. A Clinical Phase II Study to Assess Efficacy, Safety, and Tolerability of Waterfree Cyclosporine Formulation for Treatment of Dry Eye Disease. Ophthalmology. 2019 Jun;126(6):792-800. doi: 10.1016/j.ophtha.2019.01.024. Epub 2019 Jan 28.
Results Reference
result

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CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)

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