Health TrialsbyHealthPanel

An Eight-Week Study to Evaluate the Safety and Efficacy of VSJ-110 Compared to Placebo in the Treatment of Dry Eye

ConditionDry Eye
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorVanda Pharmaceuticals

About this trial

The purpose of this study is to determine the safety and efficacy of VSJ-110 compared to placebo in the treatment of dry eye.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Use of any of the disallowed medications during the washout and study period.

Trial design

Design model

Parallel

Treatments tested in this trial

  • VSJ-110

    Drug

    ophthalmic solution

  • Placebo

    Drug

    ophthalmic solution

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: VSJ-110 SolutionExperimental treatment 1 intervention
Group B: Placebo SolutionPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Corneal Staining

Corneal Staining will be assessed by the investigator on a scale of 0-4, with a higher number indicating a higher grade of staining.

Time frame
Measured over an 8-week treatment period

Secondary outcomes

1

Schirmer's Tear Test

Schirmer tear test strips are used to measure ocular fluid.

Time frame
Measured over an 8-week treatment period
2

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).

Time frame
Measured over an 8-week treatment period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanda Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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