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Completed

NCT Number: NCT04737928

Prospective, Single Center Switching Study of 0.0015% Tafluprost Ophthalmic Solution in Primary Open-angle Glaucoma and Ocular Hypertension Patients With Corneal Disorders (Switching From 0.005% Latanoprost Ophthalmic Solution)

The objective of this study was to investigate the improving effect of corneal disorder in primary open-angle glaucoma and ocular hypertension patients, when switched from the 0.005% latanoprost ophthalmic solution (one drop at a time, once daily) to the 0.0015% tafluprost ophthalmic solution (one drop at a time, once daily). Efficacy also was investigated.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chi Mei Hospital Liouying Branch

Tainan, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of 20 years or older and those who was provided informed consent.
  • POAG or OH patients whose IOP did not exceed 22 mmHg at Visit 0.
  • Patients had treated with prostaglandin ophthalmic solution (0.005% Latanoprost) for at least 3 months before enrollment.
  • Patients who had corneal disorders due to the PG usage. (At least one eye had a score above 1 on the NEI scale)
  • If only one eye was eligible, it was evaluated. When both eyes were eligible, then the eye with a higher NEI score was selected for evaluation.
  • Outpatients who visited the clinic on the designated day as instructed by the physician.

Exclusion criteria

  • Those with severe visual field disorder (Mean deviation of 15 dB or worse).
  • Those who received corneal refractive surgery.
  • Those with a history of ocular surgeries (such as corneal refractive surgery, intraocular surgery including ocular laser treatment which affected the patient's ocular surface condition) within 3 months prior to enrollment.
  • Any corneal abnormality or other condition preventing IOP measurement.
  • Those who used artificial tears to relieve dry eye symptoms.
  • Those with severe dry eye, ocular allergy, ocular infection or ocular inflammation which considered affect interpretation of the results of the study. Those who used systemic or ophthalmic steroids (excluding topical skin steroidal ointment) and anti-glaucoma agents other than prostaglandin ophthalmic solution.
  • Female patients who were pregnant, nursing or lactating.
  • Those with a history of drug allergy (hypersensitivity) to the drugs to be used during the study period (anesthetic ophthalmic solution, fluorescein, etc.) or similar drugs to the study medication.
  • Those who wore contact lenses during the study period.
  • Those who had participation in another clinical trial involving an investigational drug/device, or participation in such a trial within the last 30 days.

Treatment and study plan

latanoprost

Drug

latanoprost 0.05%(one drop, once daily)

tafluprost

Drug

tafluprost 0.015% (one drop, once daily)

Primary outcomes

  1. Efficacy: Changes in the Intraocular Pressure (IOP) at each visit

    Time frame: 3 months

    Tonometer

  2. Safety:Changes in the fluorescein staining score (NEI) at Visit 2

    Time frame: 3 months

    fluorescein staining

Secondary outcomes

  1. Changes in the fluorescein staining score (NEI) at Visit 1

    Time frame: 1 months

    fluorescein staining

  2. Changes in ocular symptoms (irritation/burning/stinging, foreign body sensation, tearing, itching and dry eye sensation) at each visit

    Time frame: 3 months

    Questionnaire

  3. Changes in the Tear Break-Up Time (TBUT) at each visit

    Time frame: 3 months

    slit-lamp

  4. Changes in the hyperaemia at each visit

    Time frame: 3 months

    slit-lamp

  5. Treatment compliance

    Time frame: 3 months

    Questionnaire

  6. Concomitant medication

    Time frame: 3 months

    Questionnaire

  7. Patient satisfaction about test medication

    Time frame: 3 months

    Questionnaire

  8. Usability of eyedrop bottle

    Time frame: 3 months

    Questionnaire

  9. Adverse drug reactions

    Time frame: 3 months

    Questionnaire

Sponsors and collaborators

Lead sponsor

Santen Pharmaceutical (Taiwan) Co., LTD

Industry

Registry information

Official study title

Prospective, Single Center Switching Study of 0.0015% Tafluprost Ophthalmic Solution in Primary Open-angle Glaucoma and Ocular Hypertension Patients With Corneal Disorders

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 4, 2021
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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