Dry EyePhase 2NCT02235259
Efficacy and Safety of XG-104 for the Treatment of Dry Eye
A Phase 2 study testing XG-104 in people with Dry Eye, run by Xigen SA at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- XG-104
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Feb 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Andover Eye Associates
Andover, Massachusetts, 01810
About this study
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
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
- Conditions
- Dry Eye
- Being tested
- XG-104, Placebo
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XG-104Drug
Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| XG-104 low dose | Experimental | Not described Receives: Drug: XG-104 |
| XG-104 intermediate dose | Experimental | Not described Receives: Drug: XG-104 |
| XG-104 high dose | Experimental | Not described Receives: Drug: XG-104 |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Fluorescein Staining: in the inferior region change from Pre-CAESM to Post- CAESM, as measured by the Ora CalibraTM Scale
Measured: Day 29
Worst Dry Eye Symptom
Measured: From D22 to Day 28
Secondary outcomes (29)
Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM
Measured: Day 15
Fluorescein Staining using Ora Calibra™ Scale and NEI Scale (all régions) Pre- and Post-CAESM
Measured: 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
Measured: 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
Measured: Day 29
Tear Film Break-up Time (Pre- and Post-CAESM)
Measured: Day 15
Tear Film Break-up Time (Pre- and Post-CAESM)
Measured: Day 29
Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)
Measured: Day 15
Conjunctival Redness using Ora Calibra™ Scale (Pre- and Post-CAESM)
Measured: Day 29
Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)
Measured: Day 15
Lid Margin Redness using Ora Calibra scale (Pre- and Post-CAESM)
Measured: Day 29
Tear Osmolarity (Post-CAESM)
Measured: Day 1
Tear Osmolarity (Post-CAESM)
Measured: Day 29
Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology
Measured: Day 15
Blink Rate (Pre-CAESM ) using Ora Calibra™ Methodology
Measured: Day 29
Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology
Measured: Day 15
Ocular Protection Index (OPI 2.0) (Pre-CAESM ) using Ora Calibra™ Methodology
Measured: Day 29
Unanesthetized Schirmer's Test (Pre-CAESM)
Measured: Day 15
Unanesthetized Schirmer's Test (Pre-CAESM)
Measured: Day 29
Drop Comfort and Symptom Assessment using Ora Calibra™ Scales
Measured: Day 1
Drop Comfort and Symptom Assessment using Ora Calibra™ Scales
Measured: Day 15
Ocular Surface Disease Index (OSDI) (Pre-CAESM)
Measured: Day 15
Ocular Surface Disease Index (OSDI) (Pre-CAESM)
Measured: Day 29
Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)
Measured: Day 15
Ocular Discomfort using Ora Calibra™ Scale (Pre and Post-CAESM)
Measured: Day 29
Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)
Measured: Day 15
Ocular Discomfort using Ora Calibra™ Discomfort and 4-Symptom Questionnaire (Pre and Post-CAESM)
Measured: Day 29
Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)
Measured: Day 15
Ocular Discomfort using Ora Calibra™ Scale (during CAESM exposure)
Measured: Day 29
Daily diary
Measured: up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xigen SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gail Torkildsen, MD, Principal investigator, Andover Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235259
- Sponsor's protocol ID
- SDD-1004-059
- Status last verified
- Jul 2016
- First submitted
- 5 Sep 2014
- Last updated
- 18 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02235259
- Acronym / sponsor ID
- SDD-1004-059
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Xigen SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XG-104Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy | Drug | XG-104 high dose, XG-104 intermediate dose, XG-104 low dose |
| Placebo | Drug | Placebo |
Primary outcome
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
29 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gail Torkildsen, MD principal investigator
Andover Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XG-104 in people with Dry Eye, run by Xigen SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.