NCT02235259

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 9, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

Enrollment Period

5 months

First QC Date

September 5, 2014

Last Update Submit

July 15, 2016

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

  • Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale

    Day 29

  • Worst Dry Eye Symptom

    From D22 to Day 28

Secondary Outcomes (29)

  • Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM

    Day 15

  • Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM

    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

    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

    Day 29

  • Tear Film Break-up Time (Pre- and Post-CAESM)

    Day 15

  • +24 more secondary outcomes

Other Outcomes (13)

  • Visual Acuity (ETDRS) (Pre-CAESM)

    Day -7

  • Visual Acuity (ETDRS) (Pre-CAESM)

    Day 1

  • Visual Acuity (ETDRS) (Pre-CAESM)

    Day 15

  • +10 more other outcomes

Study Arms (4)

XG-104 low dose

EXPERIMENTAL
Drug: XG-104

XG-104 intermediate dose

EXPERIMENTAL
Drug: XG-104

XG-104 high dose

EXPERIMENTAL
Drug: XG-104

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

XG-104DRUG

Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy

XG-104 high doseXG-104 intermediate doseXG-104 low dose
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Gail Torkildsen, MD

    Andover Eye Associates

    PRINCIPAL INVESTIGATOR

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

September 5, 2014

First Posted

September 9, 2014

Study Start

September 1, 2014

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

US(1)