Recruiting PHASE4 Ophthalmology

New treatment option for Ophthalmology

Official title Optimizing the Ocular Surface With Systane COMPLETE Pre- and Post-operatively in Patients With Dry Eye Planning for Cataract Surgery: An Extension Study of Optimizing the Ocular Surface With Systane COMPLETE in Patients With Dry Eye Planning for Cataract Surgery

ClinicalTrials.gov ID: NCT06886373

What this study is testing

What is Systane Complete?

Systane Complete is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for ophthalmology.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Compare the corneal astigmatism data before and after the use of Systane COMPLETE to evaluate its impact on predicting changes in postoperative residual astigmatism, as well as the effects of using or not using Systane COMPLETE on preoperative and postoperative Ocular Surface Disease Index (OSDI) scores and Non-Invasive Tear Break-Up Time (NITBUT).
  • Phase 4: studies an already-approved treatment

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 20 to 85

You may be able to join if

  • (Experimental group ): Cataract patients who participated in the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye...

You likely can't join if

  • (Experimental group ): Patients unwilling to participate in this trial after surgery. Inclusion Criteria(Control group):
  • Cataract patients aged between 20 and 85 years.
  • Patients with normal cognitive function who are able to complete the dry eye questionnaire (with - responses recorded by the research team) and are...
  • Unable to answer the questions in the dry eye survey.
  • Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins...
  • Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect.
See the full eligibility criteria
Who can join
  • (Experimental group ): Cataract patients who participated in the "Optimizing the Ocular Surface with Systane COMPLETE in Patients with Dry Eye Planning for Cataract Surgery" trial (Research Ethics Committee Approval...
What rules you out
  • (Experimental group ): Patients unwilling to participate in this trial after surgery. Inclusion Criteria(Control group):
  • Cataract patients aged between 20 and 85 years.
  • Patients with normal cognitive function who are able to complete the dry eye questionnaire (with - responses recorded by the research team) and are willing to undergo phacoemulsification and intraocular lens...
  • Unable to answer the questions in the dry eye survey.
  • Ocular trauma or ocular surgery in the planned surgical eye, active ocular infection, and obvious abnormalities in ocular surface or eyelid margins other than MGD cause decreased visual acuity other than cataracts.
  • Dry eye signs: Corneal Fluorescein Staining CFS (+) to exclude any corneal abnormalities or epithelial defect.
  • Systemic drug use, including tetracycline derivatives, antihistamines, and isotretinoin.
  • Using dry eye medication at screening stage.

The study team makes the final eligibility decision.

Where it's taking place

  • Taipei, Taiwan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 20 years to 85 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.