Primary Open Angle GlaucomaNCT04461249
Comparison Between Latanoprost , Travoprost and Tafluprost in Reducing IOP Fluctuation in POAG Patients
An observational study of Primary Open Angle Glaucoma, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Elevated IOP is a key risk factor for the progression of glaucoma. IOP is subjected to diurnal fluctuation in healthy individuals and higher fluctuation in POAG . So, once-daily antiglaucoma drugs must have consistent efficacy throughout the day. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Open Angle Glaucoma
- What is being tested?
- Latanoprost 0.005% Ophthalmic Solution, Travoprost 0.004% ophthalmic solution and Tafluprost Ophthalmic 0.0015% Ophthalmic Solution
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2019to 1 Apr 2020
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed primary open-angle glaucoma patients presented to the Glaucoma outpatient clinic, Kasr El-Aini hospital, Cairo University.
Who may be able to join
- Both genders aged 18 years or more.
- Newly diagnosed POAG cases having :
- IOP more than 21 mmHg Open angle on gonioscopy Showing both structural and functional damage (confirmed with OCT and visual field)
Who cannot join
- Angle closure glaucoma.
- Secondary glaucomas.
- Advanced glaucoma likely to be uncontrolled on monotherapy or needing a low target IOP.
- History of ocular trauma, laser or intraocular surgery.
- Any other ocular disorder including uveitis and cystoid macular edema.
- Known history of allergy or sensitivity to any components of the study medications.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between the Effect of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on Diurnal Intraocular Pressure Fluctuation in Patients Having Primary Open-angle Glaucoma
Elevated IOP is a key risk factor for the progression of glaucoma. IOP is subjected to diurnal fluctuation in healthy individuals and higher fluctuation in POAG . So, once-daily antiglaucoma drugs must have consistent efficacy throughout the day. Prostaglandin analogues (PGAs) have become the first-line drops for medical treatment of glaucoma worldwide. In our study, we compare between the efficacy and tolerability of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on diurnal IOP fluctuation in patients having POAG, IOP fluctuation was assessed before treatment , then 2 weeks and 6 weeks after. A comparable and significant reduction in IOP fluctuation occurred in the 3 groups. Side effects were mild and tolerable.
- Conditions
- Primary Open Angle Glaucoma
- Being tested
- Latanoprost 0.005% Ophthalmic Solution, Travoprost 0.004% ophthalmic solution, Tafluprost Ophthalmic 0.0015% Ophthalmic Solution
- Keywords
- Prostaglandin analogues
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost 0.005% Ophthalmic SolutionDrug
Also called Xalatan
Latanoprost eye drops was given to newly diagnosed primary open-angle glaucoma patients once by night and intraocular pressure fluctuation was measured using Goldmann applanation tonometer.
Travoprost 0.004% ophthalmic solutionDrug
Also called Travatan
Travoprost eye drops was given to newly diagnosed primary open-angle glaucoma patients once by night and intraocular pressure fluctuation was measured using Goldmann applanation tonometer.
Tafluprost Ophthalmic 0.0015% Ophthalmic SolutionDrug
Also called Saflutan
Tafluprost eye drops was given to newly diagnosed primary open-angle glaucoma patients once by night and intraocular pressure fluctuation was measured using Goldmann applanation tonometer.
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost group | Latanoprost 0.005 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients. Receives: Drug: Latanoprost 0.005% Ophthalmic Solution | |
| Travoprost group | Travoprost 0.004 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients. Receives: Drug: Travoprost 0.004% ophthalmic solution | |
| Tafluprost group | Tafluprost 0.0015 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients. Receives: Drug: Tafluprost Ophthalmic 0.0015% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare Between the Efficacy of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on Diurnal Intraocular Pressure Fluctuation in Patients Having Primary Open-angle Glaucoma
Newly diagnosed primary open-angle glaucoma patients received one of the 3 study medications and intraocular pressure fluctuation measured in mmHg by using Goldmann applanation tonometer was compared to the baseline intraocular pressure and to vompare its efficacy to the other 2 drugs
Measured: 3 months from starting the treatment
Secondary outcomes (1)
To Compare Between the 3 drugs regarding their tolerability and assess their side effects.
All patients were subjected to full Ophthalmological examination before starting the treatment and were assessed in the follow up visits to detect the tolerability of the drugs and detect the occurrence of side effects as dry eyes using shirmer's test, also red eyes, eye lashes Lengthening, periocular pigmentation were evaluated by photography comparing to the baseline
Measured: 3 Months from starting the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start1 Jun 2019
- Primary completion28 Feb 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Open Angle 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Essam Faseeh, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461249
- Sponsor's protocol ID
- 411993
- Status last verified
- Jul 2020
- First submitted
- 27 Jun 2020
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
El Hajj Moussa WG, Farhat RG, Nehme JC, Sahyoun MA, Schakal AR, Jalkh AE, Abi Karam MP, Azar GG. Comparison of Efficacy and Ocular Surface Disease Index Score between Bimatoprost, Latanoprost, Travoprost, and Tafluprost in Glaucoma Patients. J Ophthalmol. 2018 Mar 7;2018:1319628. doi: 10.1155/2018/1319628. eCollection 2018.
PubMed 29707390
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the Effect of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on Diurnal Intraocular Pressure Fluctuation in Patients Having Primary Open-angle Glaucoma
- ClinicalTrials.gov ID
- NCT04461249
- Acronym / sponsor ID
- 411993
- Conditions
- Primary Open Angle Glaucoma
- Keywords
- Prostaglandin analogues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 8 Jul 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.
Elevated IOP is a key risk factor for the progression of glaucoma. IOP is subjected to diurnal fluctuation in healthy individuals and higher fluctuation in POAG . So, once-daily antiglaucoma drugs must have consistent efficacy throughout the day. Prostaglandin analogues (PGAs) have become the first-line drops for medical treatment of glaucoma worldwide. In our study, we compare between the efficacy and tolerability of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on diurnal IOP fluctuation in patients having POAG, IOP fluctuation was assessed before treatment , then 2 weeks and 6 weeks after. A comparable and significant reduction in IOP fluctuation occurred in the 3 groups. Side effects were mild and tolerable.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Latanoprost group | – | Drug: Latanoprost 0.005% Ophthalmic SolutionLatanoprost 0.005 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients. |
| Travoprost group | – | Drug: Travoprost 0.004% ophthalmic solutionTravoprost 0.004 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients. |
| Tafluprost group | – | Drug: Tafluprost Ophthalmic 0.0015% Ophthalmic SolutionTafluprost 0.0015 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed primary open-angle glaucoma patients presented to the Glaucoma outpatient clinic, Kasr El-Aini hospital, Cairo University.
Key inclusion criteria (3 listed)
- Both genders aged 18 years or more.
- Newly diagnosed POAG cases having :
- IOP more than 21 mmHg Open angle on gonioscopy Showing both structural and functional damage (confirmed with OCT and visual field)
Key exclusion criteria (6 listed)
- Angle closure glaucoma.
- Secondary glaucomas.
- Advanced glaucoma likely to be uncontrolled on monotherapy or needing a low target IOP.
- History of ocular trauma, laser or intraocular surgery.
- Any other ocular disorder including uveitis and cystoid macular edema.
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 |
|---|---|---|
| Latanoprost 0.005% Ophthalmic SolutionAlso: XalatanLatanoprost eye drops was given to newly diagnosed primary open-angle glaucoma patients once by night and intraocular pressure fluctuation was measured using Goldmann applanation tonometer. | Drug | Latanoprost group |
| Travoprost 0.004% ophthalmic solutionAlso: TravatanTravoprost eye drops was given to newly diagnosed primary open-angle glaucoma patients once by night and intraocular pressure fluctuation was measured using Goldmann applanation tonometer. | Drug | Travoprost group |
| Tafluprost Ophthalmic 0.0015% Ophthalmic SolutionAlso: SaflutanTafluprost eye drops was given to newly diagnosed primary open-angle glaucoma patients once by night and intraocular pressure fluctuation was measured using Goldmann applanation tonometer. | Drug | Tafluprost group |
Primary outcome
To Compare Between the Efficacy of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on Diurnal Intraocular Pressure Fluctuation in Patients Having Primary Open-angle Glaucoma
Time frame: 3 months from starting the treatment
Newly diagnosed primary open-angle glaucoma patients received one of the 3 study medications and intraocular pressure fluctuation measured in mmHg by using Goldmann applanation tonometer was compared to the baseline intraocular pressure and to vompare its efficacy to the other 2 drugs
1 secondary outcome
To Compare Between the 3 drugs regarding their tolerability and assess their side effects.
Time frame: 3 Months from starting the treatment
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 8 Jul 2020.
- Background: PubMed 29707390El Hajj Moussa WG, Farhat RG, Nehme JC, Sahyoun MA, Schakal AR, Jalkh AE, Abi Karam MP, Azar GG. Comparison of Efficacy and Ocular Surface Disease Index Score between Bimatoprost, Latanoprost, Travoprost, and Tafluprost in Glaucoma Patients. J Ophthalmol. 2018 Mar 7;2018:1319628. doi: 10.1155/2018/1319628. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open Angle Glaucoma, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 inclusion and 6 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 8 Jul 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 Egypt. 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.
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?
To Compare Between the Efficacy of Latanoprost 0.005%, Travoprost 0.004% and Tafluprost 0.0015% on Diurnal Intraocular Pressure Fluctuation in Patients Having Primary Open-angle Glaucoma (time frame: 3 months from starting the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04461249, which also lists 1 linked publication.
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 8 Jul 2020.