DB RCT for Specialized Phototherapy in Parkinson's Disease. (LIGHT-PD)

November 11, 2025 updated by: PhotoPharmics, Inc.

Double-blind, Randomized Controlled Trial to Demonstrate Efficacy of Celeste® Specialized Phototherapy in Treating Parkinson's Disease.

This is a pivotal study to determine whether light therapy can improve non-motor and motor function in Parkinson's disease, on top of current best medical treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Six month double blind, randomized controlled study with virtual clinic visits at baseline, week 13 and week 26. The Celeste specialized phototherapy device is similar to a tablet with a stand that allows the device to be angled towards the participant's face. The light is to be used each evening in the home for 1 hour, while the participant watches TV, eats dinner, reads, etc. The primary outcome measure is the Parkinson's Disease Questionnaire-39 Summary Index (PDQ-39SI). The PDQ-39 is a patient-reported, quality of life scale. The key secondary endpoint is Parts 1 and 2 of the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The MDS-UPDRS Parts 1 and 2 measure non-motor and motor function in Parkinson's. Participants will be assessed via online videoconferences.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
350

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Diagnosis of Parkinson's disease as determined by the study PI, in keeping with the UK PD Society Brain Bank Criteria for the Diagnosis of PD

Responsiveness to dopaminergic medication, as judged by the rater, and have been using treatment for at least the past 1 year

Relatively good eyesight as attested to by participants (Corrective lenses of at least 20/60)

Stable levodopa and other anti-PD medications for at least 28 days prior to screening -

Exclusion Criteria:

Diagnosis of an atypical Parkinsonian syndrome

Significant OFF state or bothersome dyskinesias that in the judgment of the rater, would interfere with participation in the study.

An anticipated need for a change in dopamine replacement therapy, concomitant medications, OTC/supplements, or other alternative therapies during the participant's involvement in the investigation

History of previous light therapy use for PD

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Investigational Device
The Celeste device resembles a large tablet. It has a protective cover that folds into a stand and is magnetically attached to the back of the device. It produces a low intensity of specific bandwidths of light believed to be responsible for circadian and alerting responses in humans. The overall emission produces a pleasing soft glow of light.
Device: Celeste Specialized Phototherapy Device
Ocular phototherapy light panel
Sham Comparator: Control Device
The Control device is identical in appearance to Celeste. When turned on, the device emits a soft diffused light that is indistinguishable in color from the Active Device. However, this device produces a different amount of the specific wavelengths thought to be effective in the Active Device. It is impossible to tell the difference between the sham device and the active device by looking at them.
Device: Celeste Specialized Phototherapy Device
Ocular phototherapy light panel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Parkinson's Disease Questionnaire-39 (PDQ-39)
Time Frame: 26 weeks
The Parkinson's Disease Questionnaire-39 (PDQ-39) is a patient-reported rating scale for quality of life in Parkinson's disease. Respondents affirm if they have experienced problems due to their disease using a five point scale from never (0 points) to always (4 points, or worse) in doing common activities. The PDQ-39 is comprised of 8 domains: mobility, emotion, activities of daily living, cognition, stigma, social support, communication, bodily discomfort. Total possible range of scores = 0 - 156, with higher scores representing worse severity.
26 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Movement Disorders Society-Unified Parkinson's Disease Rating Scale, Sum or Parts 1+2
Time Frame: 26 weeks

MDS-UPDRS Part 1: Non-motor impact of experiences of daily living. Part I has 13 questions, the first 6 are assessed by the examiner, and the remaining 7 are usually self assessed, but may include the patient's caregiver. Each question = 0-4, range= 0 - 65, with higher scores representing worse severity.

MDS-UPDRS Part II: Motor Aspects of Experiences of Daily Living: This portion of the scale assesses the motor impact of PD on patients' experiences of daily living. There are 13 questions which are a component of the self-administered Patient Questionnaire. Each question = 0-4, range = 0-65. with higher scores representing worse severity.
26 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale (ESS)
Time Frame: 26 weeks
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness to help in diagnosing sleep disorders. The ESS questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 (none) to 3 (worse) for eight different everyday situations. The total range is 0 - 24, with higher scores representing worse severity.
26 weeks
Beck Depression Inventory -II (BDI-II)
Time Frame: 26 weeks
The Beck Depression Inventory (BDI) is a 21-question multiple choice inventory to measure the severity of depression. Each question is scored on a scale value of 0 to 3. The cutoffs used are: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms.
26 weeks
Beck Anxiety Scale (BAI)
Time Frame: 26 weeks
The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63). Input from a caregiver to the participant is acceptable.
26 weeks
Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep)
Time Frame: 26 weeks
The SCOPA-SLEEP is a frequency measure scale to assess the character and quantify the various aspects of sleep problems in Parkinson's disease. The SCOPA-Sleep consists of 13 items, including information about the use of sleeping tablets. Questions range from 0 to 4 in severity, (Question 7, Quality of Sleep, ranges from 0-7). A higher total score indicates more severe sleep problems.
26 weeks
Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part 3 (Modified)
Time Frame: 26 weeks
The MDS-UPDRS Part 3 is the motor examination section of the MDS-UPDRS. It is completed by the Evaluator. Part 3 evaluates speech, tremor, bradykinesia, rigidity, spontaneity of movement, gait, and balance. Because rigidity (3.3) and postural stability (3.12) cannot be measured remotely, a modified version, which omits these questions will be used. The same rater will evaluate the same participants whenever possible, and at the same time of day. Raters must be certified in the use of the MDS-UPDRS.
26 weeks
EuroQol-5 Dimensions (EQ-5D-5L)
Time Frame: 26 weeks
The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The EQ-5D is a standardized measure of health status developed by the EuroQol Group to provide a simple, generic measure of health for clinical and economic appraisal. The instrument comprises a short descriptive system questionnaire covering five areas which assess quality of life issues, and a visual analogue scale (EQ VAS) that provides a simple descriptive profile of a respondent's health state. The 5L refers to five levels (0-4) of increasing severity for each question.
26 weeks
Parkinson's Disease Health Index (PD-HI)
Time Frame: 26 weeks
The Parkinson's Disease Health Index (PD-HI) is a highly sensitive disease specific patient response outcome measure, designed to measure the longitudinal progression of Parkinson's disease and treatment effectiveness. The PD-HI combines 13 sub-domains according to the prevalence and impact of Parkinson's symptoms on patients. Each domain is ranked by the individual on a Likert scale of 0-100, according to how the domain is currently affecting them. A higher score reflects a more severe condition. An algorithm is used to compute the total score, with 100 being the highest score possible. The PD-HI will be used at Baseline, at Week 13, and at Week 26.
26 weeks
Montreal Cognitive Assessment (MoCA)
Time Frame: 26 weeks
The Montreal Cognitive Assessment (MoCA) is a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The MoCA will be used at screening, mainly for characterization purposes and to assist the site investigators in their decisions to include participants in the trial. Higher scores indicate better cognitive function, while a score below 26 may indicate mild cognitive impairment. The MoCA will be assessed at baseline, Week 13, and Week 26.
26 weeks
Parkinson's Disease Patient Report of Problems (PD PROP)
Time Frame: 26 Weeks
The Parkinson's Disease Patient Report of Problems is an online assessment tool that allows patients to describe their most bothersome problems and how these problems affect their daily functioning in their own terms. The tool then uses algorithms and machine learning to quantify those problems and their progression with greater sensitivity and detail that is unavailable from other assessments. The PD-PROP classifies these answers into a total of 56 clinically meaningful symptoms, representing four motor and six non-motor domains. The PD PROP will be assessed at baseline, Week 13, and Week 26.
26 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
PhotoPharmics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Rochester

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ray Dorsey, MD, University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT-2401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In addition to submitting the study design and results to www.clinicaltrials.gov, the final results of the study will be published in a peer-reviewed journal after the generation of the clinical study report. Subsequent to publication and FDA submission, PhotoPharmics intends to make the data available to qualified researchers for collaboration. The general results of the trial may also be made available to study participants during a webinar.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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