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

Dry Eye Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235259
• Other study ID #: SDD-1004-059
• Status: Completed
• Phase: Phase 2
• First received: September 5, 2014
• Last updated: July 15, 2016
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: July 2016
• Source: Xigen SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• XG-104
Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy
• Placebo

Locations

Country	Name	City	State
United States	Andover Eye Associates	Andover	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Xigen SA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Visual Acuity (ETDRS) (Pre-CAESM)		Day -7	Yes
Other	Visual Acuity (ETDRS) (Pre-CAESM)		Day 1	Yes
Other	Visual Acuity (ETDRS) (Pre-CAESM)		Day 15	Yes
Other	Visual Acuity (ETDRS) (Pre-CAESM)		Day 29	Yes
Other	Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)		Day -7	Yes
Other	Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)		Day 1	Yes
Other	Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)		Day 15	Yes
Other	Slit-Lamp Biomicroscopy (Pre- and Post-CAESM)		Day 29	Yes
Other	Adverse event query		up to Day 29	Yes
Other	Dilated Fundoscopy Biomicroscopy		Day -7	Yes
Other	Dilated Fundoscopy Biomicroscopy		Day 29	Yes
Other	Intraocular Pressure		Day -7	Yes
Other	Intraocular Pressure		Day 29	Yes
Primary	Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale		Day 29	No
Primary	Worst Dry Eye Symptom		From D22 to Day 28	No
Secondary	Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM		Day 15	No
Secondary	Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM		Day 29	No
Secondary	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	No
Secondary	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	No
Secondary	Tear Film Break-up Time (Pre- and Post-CAESM)		Day 15	No
Secondary	Tear Film Break-up Time (Pre- and Post-CAESM)		Day 29	No
Secondary	Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)		Day 15	No
Secondary	Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)		Day 29	No
Secondary	Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)		Day 15	No
Secondary	Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)		Day 29	No
Secondary	Tear Osmolarity (Post-CAESM)		Day 1	No
Secondary	Tear Osmolarity (Post-CAESM)		Day 29	No
Secondary	Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology		Day 15	No
Secondary	Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology		Day 29	No
Secondary	Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology		Day 15	No
Secondary	Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology		Day 29	No
Secondary	Unanesthetized Schirmer's Test (Pre-CAESM)		Day 15	No
Secondary	Unanesthetized Schirmer's Test (Pre-CAESM)		Day 29	No
Secondary	Drop Comfort and Symptom Assessment using Ora Calibra™ Scales		Day 1	No
Secondary	Drop Comfort and Symptom Assessment using Ora Calibra™ Scales		Day 15	No
Secondary	Ocular Surface Disease Index (OSDI) (Pre-CAESM)		Day 15	No
Secondary	Ocular Surface Disease Index (OSDI) (Pre-CAESM)		Day 29	No
Secondary	Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)		Day 15	No
Secondary	Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)		Day 29	No
Secondary	Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)		Day 15	No
Secondary	Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)		Day 29	No
Secondary	Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)		Day 15	No
Secondary	Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)		Day 29	No
Secondary	Daily diary		up to Day 29	No