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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04737928
Recruitment Status : Completed
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Santen Pharmaceutical (Taiwan) Co., LTD

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Glaucoma, Primary Open Angle Drug: Latanoprost Drug: tafluprost Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective, Single Center Switching Study of 0.0015% Tafluprost Ophthalmic Solution in Primary Open-angle Glaucoma and Ocular Hypertension Patients With Corneal Disorders
Actual Study Start Date : April 2, 2018
Actual Primary Completion Date : January 22, 2019
Actual Study Completion Date : January 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: latanoprost switch to tafluprost
POAG and OH patients prescribed latanoprost(QID) at least 3 months (IOP>20). At least one eye must have a score above 1 on the NEI scale. Switch to latanoprost (QID) for 3 months.
Drug: Latanoprost
latanoprost 0.05%(one drop, once daily)

Drug: tafluprost
tafluprost 0.015% (one drop, once daily)




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04737928


Locations
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Taiwan
Chi Mei Hospital Liouying Branch
Tainan, Taiwan
Sponsors and Collaborators
Santen Pharmaceutical (Taiwan) Co., LTD
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Responsible Party: Santen Pharmaceutical (Taiwan) Co., LTD
ClinicalTrials.gov Identifier: NCT04737928    
Other Study ID Numbers: TFT-IIR_TW001
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Corneal Diseases
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions