Glaucoma; DrugsNCT03595865
Efficacy of Tafluprost as an Adjunct to Medical Therapy for Residual Glaucoma After Trabeculectomy
A study testing tafluprostin in people with Glaucoma; Drugs, run by wangdabo.
Trial summary
A 6-month, parallel-group study of the safety and efficacy of tafluprostin for Chinese patients with posttrabeculectomy residual primary angle-closure glaucoma or posttrabeculectomy residual primary open angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glaucoma; Drugs
- What is being tested?
- tafluprostin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2018to 1 Jun 2020
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergone trabeculectomy at least 30 days a mean intraocular pressure (IOP) between 21 and 35mmHg documented residual PACG/POAG after trabeculectomy visual acuity was more than 0.1
Who cannot join
- women who were of childbearing potential (not postmenopausal or surgically sterile), pregnant, or nursing previous ocular mechanical trauma ocular infection or ocular inflammation any abnormality preventing reliable applanation tonometry of either eye cannot be safely discontinued from use of all ocular hypotensive medication(s) for a minimum period of 5 days to a maximum period of 4 weeks best-corrected visual acuity worse than 1.0 logMAR in study eye wore contact lenses refractive surgery or intraocular surgery within past 3 months severe or serious hypersensitivity to prostaglandins, prostaglandin analogs, or to any components of the study medications severe, unstable, or uncontrolled cardiovascular, hepatic, or renal disease less than 1 month stable dosing regimen of any medication used on a chronic basis that could affect IOP use of steroid or nonsteroid anti-inflammatory drug within 1 month therapy with another investigational agent within the past 30 days with other abnormal ocular condition or symptom preventing the patient from participating in the study
About this study
Official title: Efficacy of Tafluprost as an Adjunct to Medical Therapy for Residual Primary Open Angle Glaucoma and Residual Primary Angle-closure Glaucoma After Trabeculectomy
A 6-month, parallel-group study of the safety and efficacy of tafluprostin for Chinese patients with posttrabeculectomy residual primary angle-closure glaucoma or posttrabeculectomy residual primary open angle glaucoma.
Read the detailed description
Enroll 60 eyes with posttrabeculectomy glaucoma (30 eyes with posttrabeculectomy residual primary angle-closure glaucoma. 30 eyes with posttrabeculectomy residual primary open angle glaucoma). Inclusive at 9 AM at eligibility visit and previously undergone trabeculectomy at least 30 days before screening visit. Qualified patients had a mean intraocular pressure (IOP) between 21 and 35mm Hg. All patients had documented residual PACG/POAG after trabeculectomy, with inadequate IOP control in at least one eye.The right eye was selected if both eyes showed about the same IOP. The previous IOP-lowering drugs were washed out before using tafluprost. Because all of the eyes had critical IOP levels, the design of this study was open-label, with emphasis on IOP change. Both patients in PACG and POAG groups will dose 1 time daily in each eye for 6 months. Each eye will be preformed tafluprost 0.0015% at 9 PM.The investigator monitored compliance via review of bottles at each follow-up visit, and at the last visit the old bottles will be returned and the investigator will keep them for storage. Efficacy and safety evaluations will be conducted at months 1, 2, 3, 4, 5, and 6 after the start of tafluprost treatment.The IOP will be measured at 1, 2, 3, 4, 5, and 6 month visit. All IOP measurements are to be performed at about the same time of day (at 9 AM at each visit). IOP was measured by Goldmann tonometer. The IOP value was the mean of 3 consecutive measurements.A visual field examination with automated perimetry(Octopus 101) using a threshold program was performed at the screening visit. If the visual field examination has been carried out within 12 weeks before the screening visit, no additional visual filed examination is required at the screening visit. A visual field examination and RNFL(retina nerve fiber layer) examination are to be performed at screening and the last visit respectively by the same technician with the same protocol. Topical examination by slit lamp is to be performed to evaluate the anterior segment. Ophthalmoscope examinations will be performed at screening and the last visit to examine the vitreous body, retina, and optic nervehead.The efficacy of tafluprost therapy is to be evaluated by comparing the baseline IOP and the IOP at various intervals after the start of treatment, by ANOVA test. The comparison of two groups was estimated by t test. The difference of the time point IOP between the 2 groups was analyzed by X2 test.
- Conditions
- Glaucoma; Drugs
- Being tested
- tafluprostin
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tafluprostinDrug
Both patients in PACG and POAG groups will dose 1 time daily in each eye for 6months. Each eye will be preformed tafluprostin 0.0015% at 9 PM.
| Study group | Role | What they receive |
|---|---|---|
| residual primary open angle glaucoma | Experimental | Each eye will be preformed tafluprostin 0.0015% at 9 PM, 1 time daily for 6months Receives: Drug: tafluprostin |
| residual primary angle-closure glaucoma | Experimental | Each eye will be preformed tafluprostin 0.0015% at 9 PM, 1 time daily for 6months Receives: Drug: tafluprostin |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
The IOP will be measured at 1, 2, 3, 4, 5, and 6 month visit. All IOP measurements are to be performed at about the same time of day (at 9 AM at each visit). After topical anesthesia and conjunctiva sac stained byfluorescence, IOP was measured by Goldmann tonometer. The IOP value was the mean of 3 consecutive measurements.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2018
- Study start1 Aug 2018 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma; DrugsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wangdabo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wangdabo, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03595865
- Sponsor's protocol ID
- TPLS2018G
- Status last verified
- Jul 2018
- First submitted
- 25 May 2018
- Last updated
- 23 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Tafluprost as an Adjunct to Medical Therapy for Residual Primary Open Angle Glaucoma and Residual Primary Angle-closure Glaucoma After Trabeculectomy
- ClinicalTrials.gov ID
- NCT03595865
- Acronym / sponsor ID
- TPLS2018G
- Conditions
- Glaucoma; Drugs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- wangdaboUniversity, hospital or other
- Study start
- 1 Aug 2018 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 23 Jul 2018 (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.
A 6-month, parallel-group study of the safety and efficacy of tafluprostin for Chinese patients with posttrabeculectomy residual primary angle-closure glaucoma or posttrabeculectomy residual primary open angle glaucoma.
Detailed description
Enroll 60 eyes with posttrabeculectomy glaucoma (30 eyes with posttrabeculectomy residual primary angle-closure glaucoma. 30 eyes with posttrabeculectomy residual primary open angle glaucoma). Inclusive at 9 AM at eligibility visit and previously undergone trabeculectomy at least 30 days before screening visit. Qualified patients had a mean intraocular pressure (IOP) between 21 and 35mm Hg. All patients had documented residual PACG/POAG after trabeculectomy, with inadequate IOP control in at least one eye.The right eye was selected if both eyes showed about the same IOP. The previous IOP-lowering drugs were washed out before using tafluprost. Because all of the eyes had critical IOP levels, the design of this study was open-label, with emphasis on IOP change. Both patients in PACG and POAG groups will dose 1 time daily in each eye for 6 months. Each eye will be preformed tafluprost 0.0015% at 9 PM.The investigator monitored compliance via review of bottles at each follow-up visit, and at the last visit the old bottles will be returned and the investigator will keep them for storage. Efficacy and safety evaluations will be conducted at months 1, 2, 3, 4, 5, and 6 after the start of tafluprost treatment.The IOP will be measured at 1, 2, 3, 4, 5, and 6 month visit. All IOP measurements are to be performed at about the same time of day (at 9 AM at each visit). IOP was measured by Goldmann tonometer. The IOP value was the mean of 3 consecutive measurements.A visual field examination with automated perimetry(Octopus 101) using a threshold program was performed at the screening visit. If the visual field examination has been carried out within 12 weeks before the screening visit, no additional visual filed examination is required at the screening visit. A visual field examination and RNFL(retina nerve fiber layer) examination are to be performed at screening and the last visit respectively by the same technician with the same protocol. Topical examination by slit lamp is to be performed to evaluate the anterior segment. Ophthalmoscope examinations will be performed at screening and the last visit to examine the vitreous body, retina, and optic nervehead.The efficacy of tafluprost therapy is to be evaluated by comparing the baseline IOP and the IOP at various intervals after the start of treatment, by ANOVA test. The comparison of two groups was estimated by t test. The difference of the time point IOP between the 2 groups was analyzed by X2 test.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| residual primary open angle glaucoma | Experimental | Drug: tafluprostinEach eye will be preformed tafluprostin 0.0015% at 9 PM, 1 time daily for 6months |
| residual primary angle-closure glaucoma | Experimental | Drug: tafluprostinEach eye will be preformed tafluprostin 0.0015% at 9 PM, 1 time daily for 6months |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergone trabeculectomy at least 30 days a mean intraocular pressure (IOP) between 21 and 35mmHg documented residual PACG/POAG after trabeculectomy visual acuity was more than 0.1
Key exclusion criteria (1 listed)
- women who were of childbearing potential (not postmenopausal or surgically sterile), pregnant, or nursing previous ocular mechanical trauma ocular infection or ocular inflammation any abnormality preventing reliable applanation tonometry of either eye cannot be safely discontinued from use of all ocular hypotensive medication(s) for a minimum period of 5 days to a maximum period of 4 weeks best-corrected visual acuity worse than 1.0 logMAR in study eye wore contact lenses refractive surgery or intraocular surgery within past 3 months severe or serious hypersensitivity to prostaglandins, prostaglandin analogs, or to any components of the study medications severe, unstable, or uncontrolled cardiovascular, hepatic, or renal disease less than 1 month stable dosing regimen of any medication used on a chronic basis that could affect IOP use of steroid or nonsteroid anti-inflammatory drug within 1 month therapy with another investigational agent within the past 30 days with other abnormal ocular condition or symptom preventing the patient from participating in the study
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 |
|---|---|---|
| tafluprostinBoth patients in PACG and POAG groups will dose 1 time daily in each eye for 6months. Each eye will be preformed tafluprostin 0.0015% at 9 PM. | Drug | residual primary angle-closure glaucoma, residual primary open angle glaucoma |
Primary outcome
IOP
Time frame: 6 months
The IOP will be measured at 1, 2, 3, 4, 5, and 6 month visit. All IOP measurements are to be performed at about the same time of day (at 9 AM at each visit). After topical anesthesia and conjunctiva sac stained byfluorescence, IOP was measured by Goldmann tonometer. The IOP value was the mean of 3 consecutive measurements.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing tafluprostin in people with Glaucoma; Drugs, run by wangdabo.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
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?
IOP (time frame: 6 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 23 Jul 2018.