<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04461249</url>
  </required_header>
  <id_info>
    <org_study_id>411993</org_study_id>
    <nct_id>NCT04461249</nct_id>
  </id_info>
  <brief_title>Comparison Between Latanoprost , Travoprost and Tafluprost in Reducing IOP Fluctuation in POAG Patients</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kasr El Aini Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kasr El Aini Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elevated IOP is a key risk factor for the progression of glaucoma. IOP is subjected to&#xD;
      diurnal fluctuation in healthy individuals and higher fluctuation in POAG . So, once-daily&#xD;
      antiglaucoma drugs must have consistent efficacy throughout the day. Prostaglandin analogues&#xD;
      (PGAs) have become the first-line drops for medical treatment of glaucoma worldwide. In our&#xD;
      study, we compare between the efficacy and tolerability of Latanoprost 0.005%, Travoprost&#xD;
      0.004% and Tafluprost 0.0015% on diurnal IOP fluctuation in patients having POAG, IOP&#xD;
      fluctuation was assessed before treatment , then 2 weeks and 6 weeks after. A comparable and&#xD;
      significant reduction in IOP fluctuation occurred in the 3 groups. Side effects were mild and&#xD;
      tolerable.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">April 1, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <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</measure>
    <time_frame>3 months from starting the treatment</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To Compare Between the 3 drugs regarding their tolerability and assess their side effects.</measure>
    <time_frame>3 Months from starting the treatment</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">60</enrollment>
  <condition>Primary Open Angle Glaucoma</condition>
  <arm_group>
    <arm_group_label>Latanoprost group</arm_group_label>
    <description>Latanoprost 0.005 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Travoprost group</arm_group_label>
    <description>Travoprost 0.004 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tafluprost group</arm_group_label>
    <description>Tafluprost 0.0015 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Latanoprost 0.005% Ophthalmic Solution</intervention_name>
    <description>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.</description>
    <arm_group_label>Latanoprost group</arm_group_label>
    <other_name>Xalatan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Travoprost 0.004% ophthalmic solution</intervention_name>
    <description>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.</description>
    <arm_group_label>Travoprost group</arm_group_label>
    <other_name>Travatan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tafluprost Ophthalmic 0.0015% Ophthalmic Solution</intervention_name>
    <description>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.</description>
    <arm_group_label>Tafluprost group</arm_group_label>
    <other_name>Saflutan</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Newly diagnosed primary open-angle glaucoma patients presented to the Glaucoma outpatient&#xD;
        clinic, Kasr El-Aini hospital, Cairo University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Both genders aged 18 years or more.&#xD;
&#xD;
          -  Newly diagnosed POAG cases having :&#xD;
&#xD;
        IOP more than 21 mmHg Open angle on gonioscopy Showing both structural and functional&#xD;
        damage (confirmed with OCT and visual field)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Angle closure glaucoma.&#xD;
&#xD;
          -  Secondary glaucomas.&#xD;
&#xD;
          -  Advanced glaucoma likely to be uncontrolled on monotherapy or needing a low target&#xD;
             IOP.&#xD;
&#xD;
          -  History of ocular trauma, laser or intraocular surgery.&#xD;
&#xD;
          -  Any other ocular disorder including uveitis and cystoid macular edema.&#xD;
&#xD;
          -  Known history of allergy or sensitivity to any components of the study medications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kasr El-Aini hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>29707390</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>July 3, 2020</last_update_submitted>
  <last_update_submitted_qc>July 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kasr El Aini Hospital</investigator_affiliation>
    <investigator_full_name>Ahmed Essam Faseeh</investigator_full_name>
    <investigator_title>Resident of Ophthalmology</investigator_title>
  </responsible_party>
  <keyword>Prostaglandin analogues</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</mesh_term>
    <mesh_term>Glaucoma, Open-Angle</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Travoprost</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
    <mesh_term>Latanoprost</mesh_term>
    <mesh_term>Ophthalmic Solutions</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04461249
org study id: 411993
nct id: NCT04461249
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
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.
observational model: Case-Only
time perspective: Prospective
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
description: 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
measure: To Compare Between the 3 drugs regarding their tolerability and assess their side effects.
time frame: 3 Months from starting the treatment
description: 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
arm group label: Latanoprost group
description: Latanoprost 0.005 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.
arm group label: Travoprost group
description: Travoprost 0.004 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.
arm group label: Tafluprost group
description: Tafluprost 0.0015 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.
intervention type: Drug
intervention name: Latanoprost 0.005% Ophthalmic Solution
description: 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.
arm group label: Latanoprost group
other name: Xalatan
intervention type: Drug
intervention name: Travoprost 0.004% ophthalmic solution
description: 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.
arm group label: Travoprost group
other name: Travatan
intervention type: Drug
intervention name: Tafluprost Ophthalmic 0.0015% Ophthalmic Solution
description: 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.
arm group label: Tafluprost group
other name: Saflutan
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
citation: 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.
PMID: 29707390
responsible party type: Principal Investigator
investigator affiliation: Kasr El Aini Hospital
investigator full name: Ahmed Essam Faseeh
investigator title: Resident of Ophthalmology
mesh term: Glaucoma
mesh term: Glaucoma, Open-Angle
mesh term: Travoprost
mesh term: Pharmaceutical Solutions
mesh term: Latanoprost
mesh term: Ophthalmic Solutions
sharing ipd: Undecided