Dry Eye
Conditions
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
Interventions
DRUGXG-104
Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy
DRUGPlacebo
Sponsors
Xigen SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Daily diary | up to Day 29 |
| Drop Comfort and Symptom Assessment using Ora Calibra™ Scales | Day 1 |
| Ocular Surface Disease Index (OSDI) (Pre-CAESM) | Day 15 |
| Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM) | Day 15 |
| Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM) | Day 15 |
| Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure) | Day 15 |
| Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and 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 15 |
| Tear Film Break-up Time (Pre- and Post-CAESM) | Day 15 |
| Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM) | Day 15 |
| Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM) | Day 15 |
| Tear Osmolarity (Post-CAESM) | Day 1 |
| Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology | Day 15 |
| Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology | Day 15 |
| Unanesthetized Schirmer's Test (Pre-CAESM) | Day 15 |
Other
| Measure | Time frame |
|---|---|
| Slit-Lamp Biomicroscopy (Pre- and Post-CAESM) | Day -7 |
| Adverse event query | up to Day 29 |
| Dilated Fundoscopy Biomicroscopy | Day -7 |
| Intraocular Pressure | Day -7 |
| Visual Acuity (ETDRS) (Pre-CAESM) | Day -7 |
Countries
United States
Outcome results
None listed