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Efficacy and Safety of XG-104 for the Treatment of Dry Eye

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xigen SA
ClinicalTrials.gov Identifier:
NCT02235259
First received: September 5, 2014
Last updated: July 15, 2016
Last verified: July 2016
  Purpose
The objective of this study is to assess the safety and efficacy of XG-104 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye after a 4 week Three Times a Day (TID) treatment period

Condition Intervention Phase
Dry Eye Drug: XG-104 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase II, Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of XG-104 Ophthalmic Solutions in the Environment, and During Challenge in the Controlled Adverse Environmental (CAESM ) Model for the Treatment of Dry Eye

Further study details as provided by Xigen SA:

Primary Outcome Measures:
  • Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale [ Time Frame: Day 29 ]
  • Worst Dry Eye Symptom [ Time Frame: From D22 to Day 28 ]

Secondary Outcome Measures:
  • Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM [ Time Frame: Day 15 ]
  • Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM [ Time Frame: Day 29 ]
  • Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM [ Time Frame: Day 15 ]
  • Lissamine Green Staining using Ora Calibra™ Scale and NEI Scale (all regions) (Pre- and Post-CAESM and change from Pre- to Post-CAESM [ Time Frame: Day 29 ]
  • Tear Film Break-up Time (Pre- and Post-CAESM) [ Time Frame: Day 15 ]
  • Tear Film Break-up Time (Pre- and Post-CAESM) [ Time Frame: Day 29 ]
  • Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM) [ Time Frame: Day 15 ]
  • Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM) [ Time Frame: Day 29 ]
  • Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM) [ Time Frame: Day 15 ]
  • Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM) [ Time Frame: Day 29 ]
  • Tear Osmolarity (Post-CAESM) [ Time Frame: Day 1 ]
  • Tear Osmolarity (Post-CAESM) [ Time Frame: Day 29 ]
  • Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology [ Time Frame: Day 15 ]
  • Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology [ Time Frame: Day 29 ]
  • Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology [ Time Frame: Day 15 ]
  • Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology [ Time Frame: Day 29 ]
  • Unanesthetized Schirmer's Test (Pre-CAESM) [ Time Frame: Day 15 ]
  • Unanesthetized Schirmer's Test (Pre-CAESM) [ Time Frame: Day 29 ]
  • Drop Comfort and Symptom Assessment using Ora Calibra™ Scales [ Time Frame: Day 1 ]
  • Drop Comfort and Symptom Assessment using Ora Calibra™ Scales [ Time Frame: Day 15 ]
  • Ocular Surface Disease Index (OSDI) (Pre-CAESM) [ Time Frame: Day 15 ]
  • Ocular Surface Disease Index (OSDI) (Pre-CAESM) [ Time Frame: Day 29 ]
  • Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM) [ Time Frame: Day 15 ]
  • Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM) [ Time Frame: Day 29 ]
  • Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM) [ Time Frame: Day 15 ]
  • Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM) [ Time Frame: Day 29 ]
  • Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure) [ Time Frame: Day 15 ]
  • Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure) [ Time Frame: Day 29 ]
  • Daily diary [ Time Frame: up to Day 29 ]

Other Outcome Measures:
  • Visual Acuity (ETDRS) (Pre-CAESM) [ Time Frame: Day -7 ]
  • Visual Acuity (ETDRS) (Pre-CAESM) [ Time Frame: Day 1 ]
  • Visual Acuity (ETDRS) (Pre-CAESM) [ Time Frame: Day 15 ]
  • Visual Acuity (ETDRS) (Pre-CAESM) [ Time Frame: Day 29 ]
  • Slit-Lamp Biomicroscopy (Pre- and Post-CAESM) [ Time Frame: Day -7 ]
  • Slit-Lamp Biomicroscopy (Pre- and Post-CAESM) [ Time Frame: Day 1 ]
  • Slit-Lamp Biomicroscopy (Pre- and Post-CAESM) [ Time Frame: Day 15 ]
  • Slit-Lamp Biomicroscopy (Pre- and Post-CAESM) [ Time Frame: Day 29 ]
  • Adverse event query [ Time Frame: up to Day 29 ]
  • Dilated Fundoscopy Biomicroscopy [ Time Frame: Day -7 ]
  • Dilated Fundoscopy Biomicroscopy [ Time Frame: Day 29 ]
  • Intraocular Pressure [ Time Frame: Day -7 ]
  • Intraocular Pressure [ Time Frame: Day 29 ]

Enrollment: 260
Study Start Date: September 2014
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: XG-104 low dose Drug: XG-104
Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy
Experimental: XG-104 intermediate dose Drug: XG-104
Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy
Experimental: XG-104 high dose Drug: XG-104
Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy
Placebo Comparator: Placebo
Placebo
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least 18 years of age
  • Provide written informed consent
  • Have a subject reported history of dry eye
  • Have a history of use or desire to use eye drops

Exclusion Criteria:

  • Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
  • Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
  • Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
  • Have used Restasis® within 30 days of Visit 1;
  • Have any planned ocular and/or lid surgeries over the study period;
  • Be a woman who is pregnant, nursing or planning a pregnancy;
  • Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential.
  • Have a known allergy and/or sensitivity to the study drug or its components
  • Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
  • Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
  • Be unable or unwilling to follow instructions, including participation in all study assessments and visits
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02235259

Locations
United States, Massachusetts
Andover Eye Associates
Andover, Massachusetts, United States, 01810
Sponsors and Collaborators
Xigen SA
Investigators
Principal Investigator: Gail Torkildsen, MD Andover Eye Associates
  More Information

Responsible Party: Xigen SA
ClinicalTrials.gov Identifier: NCT02235259     History of Changes
Other Study ID Numbers: SDD-1004-059
Study First Received: September 5, 2014
Last Updated: July 15, 2016

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on August 18, 2017