Dry EyePhase 2NCT03598699
A Study to Evaluate AXR-159 Ophthalmic Solution in Patients With Dry Eye Disease
A Phase 2 study testing AXR-159 in people with Dry Eye, run by AxeroVision, Inc. at 3 sites in United States.
Trial summary
Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately 430 patients diagnosed with dry eye… 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?
- AXR-159
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jun 2018to 9 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female, 18 years of age or older at screening visit
- Best-corrected visual acuity (BCVA) of 20/100 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
- Reported history of dry eye for at least 6 months
- Corneal fluorescein staining score ≥ 2
- Eye dryness score ≥ 40
- Total Ocular Surface Disease Index (OSDI) score > 18
Who cannot join
- Uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
- Patient has glaucoma, ocular hypertension, on IOP-lowering medications or have previously undergone any glaucoma laser or surgical procedure.
- Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or compromised corneal integrity
- BCVA worse than 20/100 in either eye
- Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
- Keratoconjunctivitis sicca secondary to destruction of conjunctival goblet cells
Show all 9Show fewer
- Patients with clinically significant inflammation of the lid margin such as anterior blepharitis or ocular rosacea
- Recent (within the past 3 months) ocular surgery, trauma or herpes
- Use of contact lenses in either eye within one month prior to the screening visit or anticipated use during the study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Andover Eye Associates
Andover, Massachusetts, 01810
Total Eye Care, P.A.
Memphis, Tennessee, 38119
Andover Eye Associates
Raynham, Massachusetts, 02767
About this study
Official title: A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution 3 mg/mL, 30 mg/mL, and 50 mg/mL in Patients With Dry Eye Disease (DED)
Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately 430 patients diagnosed with dry eye disease (DED).
Read the detailed description
Protocol AXR201701 is designed with 2 stages. For both Stages 1 and 2, patients with signs and symptoms of DED will be randomly assigned to receive either a single concentration of AXR-159 Ophthalmic Solution or AXR-159 Ophthalmic Solution Vehicle.
A screening visit will be followed by a baseline period where subjects will dose with AXR-159 Ophthalmic Solution Vehicle for 14 days. At the end of the baseline period patients who still exhibit signs and symptoms of DED will be enrolled into a 3-month double-masked treatment period.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AXR-159Drug
AXR-159 Ophthalmic Solution
VehicleDrug
AXR-159 Ophthalmic Solution Vehicle
| Study group | Role | What they receive |
|---|---|---|
| AXR-159 Ophthalmic Solution 3 mg/mL | Experimental | AXR-159 Low Dose Receives: Drug: AXR-159 |
| AXR-159 Ophthalmic Solution 30 mg/mL | Experimental | AXR-159 Mid Dose Receives: Drug: AXR-159 |
| AXR-159 Ophthalmic Solution 50 mg/mL | Experimental | AXR-159 High Dose Receives: Drug: AXR-159 |
| AXR-159 Ophthalmic Solution Vehicle | Placebo comparator | Control Group Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inferior Corneal Staining Score
Change from Baseline in Ora Calibra® Corneal and Conjunctival Staining Scale with a range from 0 to 4 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe) in the study eye. Higher negative scores mean a better outcome.
Measured: Month 3
Eye Dryness
Change from baseline in Eye Dryness score on a subject level across both eyes. Using the visual analogue scale (VAS) subjects rated eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort with a range of 0 to 100. 0% corresponds to "no dryness" (no discomfort) and 100% corresponds to "maximal dryness" indicating maximal discomfort. A greater negative change from baseline score means a better outcome.
Measured: Month 3
Secondary outcomes (5)
Total Ocular Surface and Disease Index (OSDI) © for Dry Eye
Change from baseline in OSDI © score on a subject level. The 12-question OSDI © is assessed on a total scale from 0 to 100, where higher scores represent greater disability. A greater negative change from baseline indicates a better outcome.
Measured: Month 3
Schirmer's Test
Change from baseline in Schirmer's Test score in the study eye. Unanesthetized Schirmer's Test measures the length of the moistened area of a test strip, placed in the lower temporal lid margin of each eye, in mm following a 5-minute exposure period. Greater positive numbers indicate a better outcome.
Measured: Month 3
Tear Film Break-up Time (TBUT)
Change from baseline in the study eye with a greater positive increase indicating a better outcome. Following the instillation of a sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye and several blinks over 30 seconds, the examiner monitored the integrity of the tear film with the aid of a slit lamp, noting the time it takes to form micelles from the time that the eye is opened. TBUT was measured in seconds using a stopwatch and a digital image recording system for the right eye followed by the left eye. Values reported are for the study eye.
Measured: Month 3
Conjunctival Redness Score
Change from baseline of Ora Calibra® Conjunctival Redness Scale for Dry Eye. Scores range from 0 to 4 with 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; with higher numbers indicating more conjunctival redness. Greater negative numbers indicate a better outcome. Values reported are for the study eye.
Measured: Month 3
Total Lissamine Green Conjunctival Staining
Change from baseline of Oxford Grading Scale measuring staining within a range from 0-5 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe, 5=Confluent) for each panel (temporal and nasal) and 0-10 as the sum of both panel scores for the total exposed inter-palpebral conjunctiva. Larger negative numbers indicate reduced staining and a better outcome. Values reported are for the study eye.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start26 Jun 2018
- Primary completion28 Dec 2018
- Study completion9 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- AxeroVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Responsible party
- Sponsor
- Investigators
- Gail L Torkildson, MD, Principal investigator, Andover Eye Associates, 138 Haverhill Street, Andover MA 01810Kenneth R Kenyon, MD, Principal investigator, Andover Eye Associates, 675 Paramount Drive, Raynham, MA 02767Eugene McLaurin, MD, Principal investigator, Total Eye Care, P.A., 6060 Primacy Parkway, Memphis, TN 38119
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598699
- Sponsor's protocol ID
- AXR201701
- Status last verified
- Sep 2023
- First submitted
- 16 Jul 2018
- Last updated
- 13 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Vehicle-controlled, Randomized Study to Evaluate the Safety, Tolerability, Systemic Pharmacokinetics, and Pharmacodynamics of AXR-159 Ophthalmic Solution 3 mg/mL, 30 mg/mL, and 50 mg/mL in Patients With Dry Eye Disease (DED)
- ClinicalTrials.gov ID
- NCT03598699
- Acronym / sponsor ID
- AXR201701
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- AxeroVision, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ORA, Inc.
- Study start
- 26 Jun 2018 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 9 Jan 2019 (actual)
- First posted
- 26 Jul 2018 (actual)
- Results
- Posted 13 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Protocol AXR201701 is a multicenter, double-masked, vehicle-controlled, randomized, parallel group study carried out in 2 stages (Stage 1: AXR-159 Ophthalmic Solution (30 mg/mL or 50 mg/mL); Stage 2: AXR-159 Ophthalmic Solution (3 mg/mL, 30 mg/mL or 50 mg/mL) in approximately 430 patients diagnosed with dry eye disease (DED).
Detailed description
Protocol AXR201701 is designed with 2 stages. For both Stages 1 and 2, patients with signs and symptoms of DED will be randomly assigned to receive either a single concentration of AXR-159 Ophthalmic Solution or AXR-159 Ophthalmic Solution Vehicle.
A screening visit will be followed by a baseline period where subjects will dose with AXR-159 Ophthalmic Solution Vehicle for 14 days. At the end of the baseline period patients who still exhibit signs and symptoms of DED will be enrolled into a 3-month double-masked 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 |
|---|---|---|
| AXR-159 Ophthalmic Solution 3 mg/mL | Experimental | Drug: AXR-159AXR-159 Low Dose |
| AXR-159 Ophthalmic Solution 30 mg/mL | Experimental | Drug: AXR-159AXR-159 Mid Dose |
| AXR-159 Ophthalmic Solution 50 mg/mL | Experimental | Drug: AXR-159AXR-159 High Dose |
| AXR-159 Ophthalmic Solution Vehicle | Placebo comparator | Drug: VehicleControl Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, 18 years of age or older at screening visit
- Best-corrected visual acuity (BCVA) of 20/100 or better (Snellen equivalent), using the logarithm of the minimum angle of resolution (LogMAR) in each eye
- Reported history of dry eye for at least 6 months
- Corneal fluorescein staining score ≥ 2
- Eye dryness score ≥ 40
Key exclusion criteria (9 listed)
- Uncontrolled ocular disease (except for dry eye disease/keratoconjunctivitis sicca) or uncontrolled systemic disease
- Patient has glaucoma, ocular hypertension, on IOP-lowering medications or have previously undergone any glaucoma laser or surgical procedure.
- Corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or compromised corneal integrity
- BCVA worse than 20/100 in either eye
- Current use of punctal plugs, anticipated insertion during the study, or a history of punctal cautery in either eye
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 |
|---|---|---|
| AXR-159AXR-159 Ophthalmic Solution | Drug | AXR-159 Ophthalmic Solution 3 mg/mL, AXR-159 Ophthalmic Solution 30 mg/mL, AXR-159 Ophthalmic Solution 50 mg/mL |
| VehicleAXR-159 Ophthalmic Solution Vehicle | Drug | AXR-159 Ophthalmic Solution Vehicle |
Primary outcome
Inferior Corneal Staining Score
Time frame: Month 3
Change from Baseline in Ora Calibra® Corneal and Conjunctival Staining Scale with a range from 0 to 4 (0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe) in the study eye. Higher negative scores mean a better outcome.
Eye Dryness
Time frame: Month 3
Change from baseline in Eye Dryness score on a subject level across both eyes. Using the visual analogue scale (VAS) subjects rated eye dryness by placing a vertical mark on the horizontal line to indicate the level of discomfort with a range of 0 to 100. 0% corresponds to "no dryness" (no discomfort) and 100% corresponds to "maximal dryness" indicating maximal discomfort. A greater negative change from baseline score means a better outcome.
5 secondary outcomes
Total Ocular Surface and Disease Index (OSDI) © for Dry Eye
Time frame: Month 3
Schirmer's Test
Time frame: Month 3
Tear Film Break-up Time (TBUT)
Time frame: Month 3
Conjunctival Redness Score
Time frame: Month 3
Total Lissamine Green Conjunctival Staining
Time frame: Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Dry Eye
Active, not recruitingPhase 1/2
Study to Assess the Safety and Efficacy of OCU410 for Geographic Atrophy
Geographic Atrophy
Not yet recruitingPhase 1
A Phase 1 Study of QLS2416 Injection in Participants With Autoimmune Diseases
Systemic Lupus Erythematosus, Rheumatoid Arthritis (RA)
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
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 L Torkildson, MD principal investigator
Andover Eye Associates, 138 Haverhill Street, Andover MA 01810
Kenneth R Kenyon, MD principal investigator
Andover Eye Associates, 675 Paramount Drive, Raynham, MA 02767
Eugene McLaurin, MD principal investigator
Total Eye Care, P.A., 6060 Primacy Parkway, Memphis, TN 38119
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AXR-159 in people with Dry Eye, run by AxeroVision, Inc. at 3 sites 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 6 inclusion and 9 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 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 13 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Inferior Corneal Staining Score (time frame: Month 3). 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 13 Oct 2023.