GlaucomaPhase 4NCT04654611
Tafluprost Preservative Free Switch Study
A Phase 4 study testing preservative free tafluprost 0.0015% in people with Glaucoma and Primary Open Angle Glaucoma, run by Tun Hussein Onn National Eye Hospital at 1 site in Malaysia.
Trial summary
This study is conducted to document the effect of switching from preserved prostaglandin analogues monotherapy to preservative free tafluprost 0.0015%. The endpoints analyzed are side effect improvement in these patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma, Primary Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- preservative free tafluprost 0.0015%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Feb 2019to 1 Feb 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 21 years or older and those who can provide informed consent.
- Patients who have corneal disorders due to the prostaglandin usage. (At least one eye must have a score above 1 on the NEI scale)
- Intraocular pressure (IOP) ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
- If only one eye is eligible, it is to be evaluated. If both eyes are eligible, then the eye with a higher NEI score will be selected for evaluation.
- Pretreatment must be monotherapy with any of the following preserved ophthalmic solutions; latanoprost, travoprost, bimatoprost or tafluprost and its period must be longer than 3 months.
- Outpatients who can visit the clinic on the designated day as instructed by the physician.
- A best-corrected ETDRS visual acuity score of +0.6 logMAR (Snellen equivalent of 20 ⁄ 80) or better in each eye.
Who cannot join
- Those with severe visual field disorder (Mean deviation of 15 dB or worse)
- Those with a history of ocular surgeries (such as corneal refractive surgery, intraocular surgery including ocular laser treatment which may affect the patient's ocular surface condition) within 6 months prior to the study initiation.
- Those with severe dry eye (those in need of drug to treat dry eye), ocular allergy, ocular infection or ocular inflammation
- Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment) and anti-glaucoma agents other than latanoprost, travoprost, bimatoprost or preservative free tafluprost ophthalmic solution
- Female patients who are 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 investigational product
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- Those who need to wear contact lenses during the study period
- Any corneal abnormality or other condition preventing reliable applanation tonometry
- Anterior chamber angle less than grade 2 according to Schaffer classification as measured by Gonioscopy
- Any uncontrolled systemic disease (e.g. hypertension, diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ocular Surface Conditions in Asian Glaucoma Patients With Existing Corneal Disorders Switching From Preserved Prostaglandin Analogues Monotherapy to Preservative-free Tafluprost
This study is conducted to document the effect of switching from preserved prostaglandin analogues monotherapy to preservative free tafluprost 0.0015%. The endpoints analyzed are side effect improvement in these patients.
Read the detailed description
Importance: Glaucoma medications are often preserved with agents such as benzalkonium chloride, which commonly lead to ocular surface diseases.
Background: To investigate the effect of switching to a preservative-free prostaglandin analogue, tafluprost 0.0015% on treatment tolerability and ocular surface diseases.
Design: This was a prospective, open label, non-randomised, observational study performed in a single hospital.
Participants: Patients of Asian descent who have primary open angle glaucoma and ocular hypertension (n = 28), who received preserved prostaglandin monotherapy for longer than 3 months, and has a National Eye Institute ocular surface staining scale score higher than 1.
Methods: Patients were switched from preserved prostaglandin monotherapy to preservative-free tafluprost 0.0015%. Patients were analysed at baseline (Visit 0), 1 month (Visit 1) and 3 months (Visit 2).
Main Outcome Measures: The main parameter measured is the change in the fluorescein staining score at Visit 2.
- Conditions
- Glaucoma, Primary Open Angle Glaucoma, Ocular Hypertension
- Being tested
- preservative free tafluprost 0.0015%
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preservative free tafluprost 0.0015%Drug
preservative free prostaglandin analogue option for treatment of primary open angle glaucoma and ocular hypertension patients
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Other | The intervention will be preservative free tafluprost 0.0015% topical ophthalmic solution given once daily for the study duration. Receives: Drug: preservative free tafluprost 0.0015% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the fluorescein staining score (NEI) at Visit 2
The fluorescein stained area of the cornea will be measured according to the National Eye Institute/Industry (NEI/I) method. NEI grading scale consists of a grid that divides the corneal area into five sections, each of which is assigned a score between zero and 3 depending of the amount and distribution of Corneal Fluorescein Stain (CFS); the total CFS score ranges from 0/15 (absence of corneal epitheliopathy) to 15/15 (severe epitheliopathy)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Feb 2019
- Primary completion1 Feb 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tun Hussein Onn National Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanendthire Sangapillai, Tun Hussein Onn National Eye Hospital
- Investigators
- Hsien Han Lim, Principal investigator, Tun Hussein Onn National Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654611
- Sponsor's protocol ID
- 001
- Status last verified
- Dec 2020
- First submitted
- 23 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Surface Conditions in Asian Glaucoma Patients With Existing Corneal Disorders Switching From Preserved Prostaglandin Analogues Monotherapy to Preservative-free Tafluprost
- ClinicalTrials.gov ID
- NCT04654611
- Acronym / sponsor ID
- 001
- Conditions
- Glaucoma, Primary Open Angle Glaucoma, Ocular Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Tun Hussein Onn National Eye HospitalUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to document the effect of switching from preserved prostaglandin analogues monotherapy to preservative free tafluprost 0.0015%. The endpoints analyzed are side effect improvement in these patients.
Detailed description
Importance: Glaucoma medications are often preserved with agents such as benzalkonium chloride, which commonly lead to ocular surface diseases.
Background: To investigate the effect of switching to a preservative-free prostaglandin analogue, tafluprost 0.0015% on treatment tolerability and ocular surface diseases.
Design: This was a prospective, open label, non-randomised, observational study performed in a single hospital.
Participants: Patients of Asian descent who have primary open angle glaucoma and ocular hypertension (n = 28), who received preserved prostaglandin monotherapy for longer than 3 months, and has a National Eye Institute ocular surface staining scale score higher than 1.
Methods: Patients were switched from preserved prostaglandin monotherapy to preservative-free tafluprost 0.0015%. Patients were analysed at baseline (Visit 0), 1 month (Visit 1) and 3 months (Visit 2).
Main Outcome Measures: The main parameter measured is the change in the fluorescein staining score at Visit 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Other | Drug: preservative free tafluprost 0.0015%The intervention will be preservative free tafluprost 0.0015% topical ophthalmic solution given once daily for the study duration. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age of 21 years or older and those who can provide informed consent.
- Patients who have corneal disorders due to the prostaglandin usage. (At least one eye must have a score above 1 on the NEI scale)
- Intraocular pressure (IOP) ≤ 21 mm Hg in the study eye at the screening examination (under treatment)
- If only one eye is eligible, it is to be evaluated. If both eyes are eligible, then the eye with a higher NEI score will be selected for evaluation.
- Pretreatment must be monotherapy with any of the following preserved ophthalmic solutions; latanoprost, travoprost, bimatoprost or tafluprost and its period must be longer than 3 months.
Key exclusion criteria (10 listed)
- Those with severe visual field disorder (Mean deviation of 15 dB or worse)
- Those with a history of ocular surgeries (such as corneal refractive surgery, intraocular surgery including ocular laser treatment which may affect the patient's ocular surface condition) within 6 months prior to the study initiation.
- Those with severe dry eye (those in need of drug to treat dry eye), ocular allergy, ocular infection or ocular inflammation
- Those who need to use systemic or ophthalmic steroids (excluding topical skin steroidal ointment) and anti-glaucoma agents other than latanoprost, travoprost, bimatoprost or preservative free tafluprost ophthalmic solution
- Female patients who are pregnant, nursing or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preservative free tafluprost 0.0015%preservative free prostaglandin analogue option for treatment of primary open angle glaucoma and ocular hypertension patients | Drug | Treatment group |
Primary outcome
Changes in the fluorescein staining score (NEI) at Visit 2
Time frame: 3 months
The fluorescein stained area of the cornea will be measured according to the National Eye Institute/Industry (NEI/I) method. NEI grading scale consists of a grid that divides the corneal area into five sections, each of which is assigned a score between zero and 3 depending of the amount and distribution of Corneal Fluorescein Stain (CFS); the total CFS score ranges from 0/15 (absence of corneal epitheliopathy) to 15/15 (severe epitheliopathy)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsien Han Lim principal investigator
Tun Hussein Onn National Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing preservative free tafluprost 0.0015% in people with Glaucoma and Primary Open Angle Glaucoma, run by Tun Hussein Onn National Eye Hospital at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the fluorescein staining score (NEI) at Visit 2 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.