NCT02105311

Brief Summary

The investigators conduct this study to access the effect of selective laser trabeculoplasty on 24-hour circadian tension curves of patients with open-angle glaucoma, normal tension glaucoma and ocular hypertension. This treatment effect is compared with that of the prostaglandin analogue, travoprost.

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 phase_4

Timeline
Completed

Started Mar 2014

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

Study Start

First participant enrolled

March 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

March 28, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 7, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

March 28, 2014

Last Update Submit

August 4, 2016

Conditions

Intraocular Pressure

Keywords

Intraocular pressureSelective laser trabeculoplastyTravoprostOcular surface diseaseGlaucoma symptom scale

Outcome Measures

Primary Outcomes (1)

  • Change of circadian intraocular pressure

    intraocular pressure values measured during daytime and nighttime, compare between selective laser trabeculoplasty and travoprost (include pre- and post-treatment intraocular pressure values)

    Six weeks after recieving treatment

Secondary Outcomes (2)

  • Position related intraocular pressure

    Six weeks after the treatments

  • Ocular surface disease

    Six weeks after the treatments

Study Arms (2)

Selective laser trabeculoplasty

EXPERIMENTAL

Treating with the selective laser trabeculoplasty

Device: Selective laser trabeculoplasty

Travoprost

ACTIVE COMPARATOR

Using eye drop: travoprost

Drug: Travoprost

Interventions

Selective laser trabeculoplastyDEVICE

Selective laser trabeculoplasty platform The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel)

Also known as: The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel)
Selective laser trabeculoplasty
TravoprostDRUG

Travoprost benzalkonium-free ophthalmic solution (40 microgram/ml) (Alcon Laboratories, Inc., Fort Worth, TX, USA)

Also known as: Travatan benzalkonium-free
Travoprost

Eligibility Criteria

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

You may qualify if:

  • Age \> 18 year-old
  • Patients who were diagnosed as primary open-angle glaucoma, normal tension glaucoma, and ocular hypertension either newly diagnosed or currently on medical therapy.
  • Agree to participate in the study, accept to be randomized to receive treatment, and willing to sign an informed consent

You may not qualify if:

  • Related to the severity of disease and visual acuity status
  • Advance glaucoma in the study eye
  • Have a very high intraocular pressure that need immediate treatment to prevent retinal vein occlusion (intraocular pressure \>30 mmHg)
  • Currently on maximal tolerated medical treatment and unable to control intraocular pressure
  • Currently on oral carbonic anhydrase inhibitor for intraocular pressure control
  • Single eye, the other eye blind from any cause
  • Related to surgical procedures
  • Prior laser trabeculoplasty
  • Prior glaucoma surgery
  • Prior retinal surgery
  • Underwent less than 3-month cataract extraction
  • Potential need for other ocular surgery within the 2-3-month follow-up period since enrollment Related to underlying and ocular history
  • History of diabetic retinopathy staged as severe non-proliferative or worse
  • Narrow iridocorneal angle
  • Ocular condition precluding visualization of trabecular meshwork
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Interventions

Travoprost

Intervention Hierarchy (Ancestors)

CloprostenolProstaglandins F, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Weerawat Kiddee, MD

    Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Weerawat Kiddee

Study Record Dates

First Submitted

March 28, 2014

First Posted

April 7, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)