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

July 15, 2016 updated by: Xigen SA

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Andover, Massachusetts, United States, 01810
        • Andover Eye Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Placebo
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
Day 29
Worst Dry Eye Symptom
Time Frame: From D22 to Day 28
From D22 to Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM
Time Frame: Day 15
Day 15
Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM
Time Frame: Day 29
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
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
Day 29
Tear Film Break-up Time (Pre- and Post-CAESM)
Time Frame: Day 15
Day 15
Tear Film Break-up Time (Pre- and Post-CAESM)
Time Frame: Day 29
Day 29
Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)
Time Frame: Day 15
Day 15
Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)
Time Frame: Day 29
Day 29
Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)
Time Frame: Day 15
Day 15
Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)
Time Frame: Day 29
Day 29
Tear Osmolarity (Post-CAESM)
Time Frame: Day 1
Day 1
Tear Osmolarity (Post-CAESM)
Time Frame: Day 29
Day 29
Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology
Time Frame: Day 15
Day 15
Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology
Time Frame: Day 29
Day 29
Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology
Time Frame: Day 15
Day 15
Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology
Time Frame: Day 29
Day 29
Unanesthetized Schirmer's Test (Pre-CAESM)
Time Frame: Day 15
Day 15
Unanesthetized Schirmer's Test (Pre-CAESM)
Time Frame: Day 29
Day 29
Drop Comfort and Symptom Assessment using Ora Calibra™ Scales
Time Frame: Day 1
Day 1
Drop Comfort and Symptom Assessment using Ora Calibra™ Scales
Time Frame: Day 15
Day 15
Ocular Surface Disease Index (OSDI) (Pre-CAESM)
Time Frame: Day 15
Day 15
Ocular Surface Disease Index (OSDI) (Pre-CAESM)
Time Frame: Day 29
Day 29
Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)
Time Frame: Day 15
Day 15
Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)
Time Frame: Day 29
Day 29
Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)
Time Frame: Day 15
Day 15
Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)
Time Frame: Day 29
Day 29
Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)
Time Frame: Day 15
Day 15
Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)
Time Frame: Day 29
Day 29
Daily diary
Time Frame: up to Day 29
up to Day 29

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Visual Acuity (ETDRS) (Pre-CAESM)
Time Frame: Day -7
Day -7
Visual Acuity (ETDRS) (Pre-CAESM)
Time Frame: Day 1
Day 1
Visual Acuity (ETDRS) (Pre-CAESM)
Time Frame: Day 15
Day 15
Visual Acuity (ETDRS) (Pre-CAESM)
Time Frame: Day 29
Day 29
Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
Time Frame: Day -7
Day -7
Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
Time Frame: Day 1
Day 1
Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
Time Frame: Day 15
Day 15
Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)
Time Frame: Day 29
Day 29
Adverse event query
Time Frame: up to Day 29
up to Day 29
Dilated Fundoscopy Biomicroscopy
Time Frame: Day -7
Day -7
Dilated Fundoscopy Biomicroscopy
Time Frame: Day 29
Day 29
Intraocular Pressure
Time Frame: Day -7
Day -7
Intraocular Pressure
Time Frame: Day 29
Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xigen SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SDD-1004-059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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