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

NCT02617667 | Completed Phase 2 Results

• 1 other identifier: CYS-002
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 4

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).

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline to 113 Days

• 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".

  Baseline to 113 Days

Study Arms (4)

CyclASol Ophthalmic Solution 1

EXPERIMENTAL

Cyclosporine A solution (dose-level 1) in vehicle

Drug: Cyclosporine A

CyclASol Ophthalmic Solution 2

EXPERIMENTAL

Cyclosporine A solution (dose-level 2) in vehicle

Drug: Cyclosporine A

Placebo Ophthalmic Solution

PLACEBO COMPARATOR

Vehicle only

Drug: Placebo

Restasis

ACTIVE COMPARATOR

Cyclosporine A 0.05% ophthalmic emulsion

Drug: Cyclosporine A

Interventions

Cyclosporine A DRUG

topical ocular, eye drops

Also known as: Ciclosporin, CsA

CyclASol Ophthalmic Solution 1; CyclASol Ophthalmic Solution 2; Restasis

Placebo DRUG

topical ocular, eye drops

Also known as: Excipient

Placebo Ophthalmic Solution

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novaliq GmbH: lead

Study Sites (4)

CYS-002 Investigational Site

Newport Beach, California, 92663, United States

Location

CYS-002 Investigational Site

Lewiston, Maine, 04240, United States

Location

CYS-002 Investigational Site

Andover, Massachusetts, 01810, United States

Location

CYS-002 Investigational Site

Quincy, Massachusetts, 02169, United States

Location

Related Publications (1)

• 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.

  PMID: 30703441 RESULT

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporine; Excipients

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Pharmaceutical Vehicles; Pharmaceutic Aids; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses

Results Point of Contact

• Title: Dr Sonja Krösser, VP Preclinical and Clinical Development
• Organization: Novaliq GmbH

+49 6221 50259-0

Study Officials

• Sonja Kroesser, Dr.sc.hum.

  Novaliq GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

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: November 25, 2015
• First Posted: December 1, 2015
• Study Start: January 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: November 6, 2019
• Results First Posted: July 26, 2018

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)