Dry EyePhase 2NCT06296966
A Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye
A Phase 2 study testing VSJ-110 in people with Dry Eye, run by Vanda Pharmaceuticals at 1 site in United States.
Trial summary
The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of 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?
- VSJ-110
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Feb 2024to Jul 2024
- 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 of either gender and any race.
- Provide written informed consent and sign the HIPAA form.
- Be willing and able to follow all instructions and attend all study visits.
Who cannot join
- Use of any of the disallowed medications during the washout and study period.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Vanda Investigational Site
Andover, Massachusetts, 01810
Vanda Pharmaceuticals Inc., 202-734-3400, clinicaltrials@vandapharma.com
About this study
Official title: A Four-Week, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Dry Eye
The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.
- Conditions
- Dry Eye
- Being tested
- VSJ-110, 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.
VSJ-110Drug
ophthalmic solution
PlaceboDrug
ophthalmic solution
| Study group | Role | What they receive |
|---|---|---|
| VSJ-110 Solution | Experimental | Not described Receives: Drug: VSJ-110 |
| Placebo Solution | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's Tear Test
Schirmer's Tear Test strips are used to measure ocular fluid.
Measured: Measured over a 4-week treatment period
Secondary outcomes (2)
Ocular Staining
Ocular Staining will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher grade of staining.
Measured: Measured over a 4-week treatment period
Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)
EDS is reported by the subject using a 100-point scale (0=no discomfort and 100=maximum discomfort).
Measured: Measured over a 4-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start29 Feb 2024
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
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.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296966
- Sponsor's protocol ID
- VP-VSJ-110-2201
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Four-Week, Double-Masked, Randomized, Placebo-Controlled, Phase 2, Evaluation of the Safety and Efficacy of VSJ-110 Ophthalmic Solution in the Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT06296966
- Acronym / sponsor ID
- VP-VSJ-110-2201
- Conditions
- Dry Eye
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 6 Mar 2024 (actual)
- 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 purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VSJ-110 Solution | Experimental | Drug: VSJ-110 |
| Placebo Solution | Placebo comparator | Drug: Placebo |
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 of either gender and any race.
- Provide written informed consent and sign the HIPAA form.
- Be willing and able to follow all instructions and attend all study visits.
Key exclusion criteria (1 listed)
- Use of any of the disallowed medications during the washout and 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 |
|---|---|---|
| VSJ-110ophthalmic solution | Drug | VSJ-110 Solution |
| Placeboophthalmic solution | Drug | Placebo Solution |
Primary outcome
Schirmer's Tear Test
Time frame: Measured over a 4-week treatment period
Schirmer's Tear Test strips are used to measure ocular fluid.
2 secondary outcomes
Ocular Staining
Time frame: Measured over a 4-week treatment period
Eye Dryness Score (EDS) of the Visual Analogue Scale (VAS)
Time frame: Measured over a 4-week treatment period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
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 VSJ-110 in people with Dry Eye, run by Vanda Pharmaceuticals 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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals Inc. (202-734-3400, clinicaltrials@vandapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Schirmer's Tear Test (time frame: Measured over a 4-week treatment period). 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 6 Mar 2024.