Dry Eye SyndromePhase 2/3AUDREYNCT04147650
Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
A Phase 2/3 study testing 0.05% Voclosporin Ophthalmic Solution (VOS), 0.10% VOS and 0.20% VOS in people with Dry Eye Syndrome and Keratoconjunctivitis Sicca, run by Aurinia Pharmaceuticals Inc. at 9 sites in United States.
Trial summary
A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome, Keratoconjunctivitis Sicca
- What is being tested?
- 0.05% Voclosporin Ophthalmic Solution (VOS), 0.10% VOS and 0.20% VOS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 508 participants
- Where
- 9 sitesUnited States
- Study dates
- 14 Oct 2019to 8 Oct 2020
- Phase
- Phase 2/3
- 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
- Be at least 18 years of age.
- Have a documented history of Dry Eye prior to Visit 1.
- Willing and able to follow protocol procedures and instructions.
Who cannot join
- Have undergone cataract or LASIK surgery within 1 year prior to Visit 1.
- Recent or current evidence of infection or inflammation in either eye.
- Current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye.
- Have used any investigational drug or device within 30 days prior to Visit 1.
- Have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (OTC) agents on the date of Visit 1.
- Have worn contact lenses 24 hours prior to Visit 1.
- Have used Xiidra® (lifitegrast) within 14 days prior to Visit 1.
- Have used Calcineurin Inhibitors (CNIs) such as Restasis® (cyclosporin ophthalmic emulsion) or CequaTM within 30 days prior to Visit 1.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Aurinia Investigative Center
Andover, Massachusetts, 01810
Aurinia Investigative Center
Colorado Springs, Colorado, 80907
Aurinia Investigative Center
Cranberry Township, Pennsylvania, 16066
Aurinia Investigative Center
Lewiston, Maine, 04240
Aurinia Investigative Center
Louisville, Kentucky, 40206
Aurinia Investigative Center
Memphis, Tennessee, 38119
Aurinia Investigative Center
Nashville, Tennessee, 37205
Aurinia Investigative Center
Newport Beach, California, 92663
Aurinia Investigative Center
Raynham, Massachusetts, 02767
About this study
Official title: A Randomized, Double-Masked, Vehicle-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution (VOS) in Subjects With Dry Eye Syndrome (DES)
A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.
Read the detailed description
This is a Phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of VOS when administered in both eyes (OU) twice a day (BID) over 12 weeks in subjects with mild to moderate DES. Subjects will undergo a 14- to 17-day run-in period in which VOS vehicle will be self-administered OU, BID. Subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. It is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.
- Conditions
- Dry Eye Syndrome, Keratoconjunctivitis Sicca
- Being tested
- 0.05% Voclosporin Ophthalmic Solution (VOS), 0.10% VOS, 0.20% VOS, Vehicle Ophthalmic Solution
- Keywords
- Dry Eye Calcineurin Inhibitors, Dry Eye Disease
- Medical subject headings
- Dry Eye Syndromes, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.05% Voclosporin Ophthalmic Solution (VOS)Drug
0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
0.10% VOSDrug
0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
0.20% VOSDrug
0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
Vehicle Ophthalmic SolutionDrug
Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 0.05% Voclosporin Ophthalmic Solution (VOS) | Experimental | 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks Receives: Drug: 0.05% Voclosporin Ophthalmic Solution (VOS) |
| 0.10% VOS | Experimental | 0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks Receives: Drug: 0.10% VOS |
| 0.20% VOS | Experimental | 0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks Receives: Drug: 0.20% VOS |
| Vehicle Ophthalmic Solution | Placebo comparator | Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks Receives: Drug: Vehicle Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)
Number of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye. The STT scale is a measure of tear production with a minimum of 0 mm and no there is no specified maximum for this scale.
Measured: 4 Weeks
Secondary outcomes (1)
Change From Baseline in Eye Dryness
Mean change from baseline in Eye Dryness Visual Analogue Scale (VAS) in subjects with a baseline Eye Dryness VAS score ≥ 60 mm. Eye Dryness Visual Analogue Scale 0-100 mm, where 0 corresponds to "no discomfort" and 100 corresponds to "maximal discomfort."
Measured: Value at 4 Weeks minus value at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start14 Oct 2019
- Primary completion17 Sep 2020
- Study completion8 Oct 2020
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 Eye SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one of the following treatment groups: Investigational product (IP): one drop 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks, one drop 0.10% VOS OU BID over 12 weeks, or one drop 0.20% VOS OU BID over 12 weeks. Comparator: one drop VOS vehicle OU BID over 12 weeks.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aurinia Pharmaceuticals Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mary Palmen, Study director, Aurinia Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147650
- Sponsor's protocol ID
- AUR-VOS-2019-01
- Acronym
- AUDREY
- Status last verified
- Dec 2021
- First submitted
- 30 Oct 2019
- Last updated
- 10 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Vehicle-Controlled, Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution (VOS) in Subjects With Dry Eye Syndrome (DES)
- ClinicalTrials.gov ID
- NCT04147650
- Acronym / sponsor ID
- AUDREY / AUR-VOS-2019-01
- Conditions
- Dry Eye Syndrome, Keratoconjunctivitis Sicca
- Keywords
- Dry Eye Calcineurin Inhibitors, Dry Eye Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- Aurinia Pharmaceuticals Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 17 Sep 2020 (actual)
- Study completion
- 8 Oct 2020 (actual)
- First posted
- 1 Nov 2019 (actual)
- Results
- Posted 10 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.
Detailed description
This is a Phase 2/3, multi-center, randomized, double-masked, vehicle-controlled study to assess the efficacy and safety of three different concentrations of VOS when administered in both eyes (OU) twice a day (BID) over 12 weeks in subjects with mild to moderate DES. Subjects will undergo a 14- to 17-day run-in period in which VOS vehicle will be self-administered OU, BID. Subjects will be re-assessed to confirm they meet all of the inclusion criteria and none of the exclusion criteria. It is estimated that the study will enroll approximately 480 subjects across approximately 9 study centers. Eligible subjects will be randomized in a 1:1:1:1 ratio to one of the following study treatment groups after the 14- to 17-day run-in period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Subjects will be randomized to one of the following treatment groups: Investigational product (IP): one drop 0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks, one drop 0.10% VOS OU BID over 12 weeks, or one drop 0.20% VOS OU BID over 12 weeks. Comparator: one drop VOS vehicle OU BID over 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| 0.05% Voclosporin Ophthalmic Solution (VOS) | Experimental | Drug: 0.05% Voclosporin Ophthalmic Solution (VOS)0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks |
| 0.10% VOS | Experimental | Drug: 0.10% VOS0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks |
| 0.20% VOS | Experimental | Drug: 0.20% VOS0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks |
| Vehicle Ophthalmic Solution | Placebo comparator | Drug: Vehicle Ophthalmic SolutionVehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be at least 18 years of age.
- Have a documented history of Dry Eye prior to Visit 1.
- Willing and able to follow protocol procedures and instructions.
Key exclusion criteria (8 listed)
- Have undergone cataract or LASIK surgery within 1 year prior to Visit 1.
- Recent or current evidence of infection or inflammation in either eye.
- Current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye.
- Have used any investigational drug or device within 30 days prior to Visit 1.
- Have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (OTC) agents on the date of Visit 1.
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 |
|---|---|---|
| 0.05% Voclosporin Ophthalmic Solution (VOS)0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks | Drug | 0.05% Voclosporin Ophthalmic Solution (VOS) |
| 0.10% VOS0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks | Drug | 0.10% VOS |
| 0.20% VOS0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks | Drug | 0.20% VOS |
| Vehicle Ophthalmic SolutionVehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks | Drug | Vehicle Ophthalmic Solution |
Primary outcome
Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT)
Time frame: 4 Weeks
Number of subjects with a ≥10 mm increase from baseline in STT at Week 4 in the study eye. The STT scale is a measure of tear production with a minimum of 0 mm and no there is no specified maximum for this scale.
1 secondary outcome
Change From Baseline in Eye Dryness
Time frame: Value at 4 Weeks minus value at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mary Palmen study director
Aurinia Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 0.05% Voclosporin Ophthalmic Solution (VOS), 0.10% VOS and 0.20% VOS in people with Dry Eye Syndrome and Keratoconjunctivitis Sicca, run by Aurinia Pharmaceuticals Inc. at 9 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 3 inclusion and 8 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 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 10 Dec 2021). 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?
Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) (time frame: 4 Weeks). 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 10 Dec 2021.