NCT06158984

Brief Summary

A single center randomized controlled trial on managing dry eye signs and symptoms in patients using anti-glaucoma eye drops.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

2 months

First QC Date

February 7, 2023

Last Update Submit

December 25, 2023

Conditions

Dry Eye

Keywords

GlaucomaIPLDiquafosolDrug-induced Dry Eye

Outcome Measures

Primary Outcomes (1)

  • Non-invasive tear break-up time

    Changes in non-invasive initial tear film breaking time will be assessed using the Keratograph 5M (Oculus, Germany) topographer. Three sequentially readings will be captured, and the median value will be included in the final analysis. The median value will be recorded.

    Day-0 (baseline), 2-week, 4-weeks

Secondary Outcomes (6)

  • Conjunctival hyperemia (RS score)

    Day-0 (baseline), 2-week, 4-weeks

  • Quality of meibum grade

    Day-0 (baseline), 2-week, 4-weeks

  • Expressibility of meibum grade

    Day-0 (baseline), 2-week, 4-weeks

  • Conjunctivocorneal epithelial staining grade

    Day-0 (baseline), 1-week, 2-weeks

  • Tear Film Lipid Layer

    Day-0 (baseline), 2-week, 4-weeks

  • +1 more secondary outcomes

Study Arms (2)

IPL group

EXPERIMENTAL

IPL group will use 2 sessions of IPL therapy, 15 days apart for the management of drug-induced dry eye in glaucoma patients.

Device: IPL

Control group

NO INTERVENTION

The control group received no treatment

Interventions

IPLDEVICE

Intense pulse light (IPL) therapy is used for the treatment of drug-related dry eye in glaucoma patients.

Also known as: Intense pulsed light
IPL group

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥18 years
  • Able and willing to comply with the treatment/follow-up schedule
  • Bilateral signs and symptoms of dry eye disease

You may not qualify if:

  • Participants with systemic immune-mediated illnesses, such as secondary Sjögren's syndrome or graft-versus-host disease
  • Patients using topical medication(s) for the treatment of ocular disorders such as allergic conjunctivitis were excluded from the study.
  • Previous ocular surgery or trauma
  • month history of blepharal and periorbital skin disease or allergies
  • Severe dry eyes with corneal epithelial defect
  • Limbic keratitis
  • Pterygium
  • Corneal neovascularization
  • Breastfeeding
  • Rheumatic immune systemic diseases
  • Herpes zoster infection
  • Pregnant women
  • Allergic to fluorescein
  • Contact lens wearers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

He Eye Hospital

Shenyang, Liaoning, 110001, China

Location

Related Publications (1)

  • Zhang H, Qi Y, Chen J, Qin G, Xu L, He W, Yu S, Che H, Pazo EE. Management of Glaucoma-Related Dry Eye Disease with Intense Pulsed Light: A Randomized Control Study. Clin Ophthalmol. 2024 Jul 15;18:2061-2072. doi: 10.2147/OPTH.S471426. eCollection 2024.

    PMID: 39055379DERIVED

MeSH Terms

Conditions

Dry Eye SyndromesGlaucoma

Interventions

Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesOcular Hypertension

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics

Study Officials

  • Emmanuel Eric Pazo

    He Eye Hospital, Shenyang, China

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Masked examiner for all clinical assessments will not involved in the data collection or group allocation procedure for this research. The investigator will not be aware of the two groups.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, comparative pilot study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2023

First Posted

December 6, 2023

Study Start

October 3, 2023

Primary Completion

December 1, 2023

Study Completion

December 2, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)