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Comparison Between Latanoprost , Travoprost and Tafluprost in Reducing IOP Fluctuation in POAG Patients

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ClinicalTrials.gov Identifier: NCT04461249
Recruitment Status : Completed
First Posted : July 8, 2020
Last Update Posted : July 8, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Essam Faseeh, Kasr El Aini Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Primary Open Angle Glaucoma Drug: Latanoprost 0.005% Ophthalmic Solution Drug: Travoprost 0.004% ophthalmic solution Drug: Tafluprost Ophthalmic 0.0015% Ophthalmic Solution

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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : June 1, 2019
Actual Primary Completion Date : February 28, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort Intervention/treatment
Latanoprost group
Latanoprost 0.005 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.
Drug: Latanoprost 0.005% Ophthalmic Solution
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.
Other Name: Xalatan

Travoprost group
Travoprost 0.004 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.
Drug: Travoprost 0.004% ophthalmic solution
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.
Other Name: Travatan

Tafluprost group
Tafluprost 0.0015 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.
Drug: Tafluprost Ophthalmic 0.0015% Ophthalmic Solution
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.
Other Name: Saflutan




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. To Compare Between the 3 drugs regarding their tolerability and assess their side effects. [ Time Frame: 3 Months from starting the treatment ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Newly diagnosed primary open-angle glaucoma patients presented to the Glaucoma outpatient clinic, Kasr El-Aini hospital, Cairo University.
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

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): NCT04461249


Locations
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Egypt
Kasr El-Aini hospital
Cairo, Egypt
Sponsors and Collaborators
Kasr El Aini Hospital
Publications:
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Responsible Party: Ahmed Essam Faseeh, Resident of Ophthalmology, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT04461249    
Other Study ID Numbers: 411993
First Posted: July 8, 2020    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ahmed Essam Faseeh, Kasr El Aini Hospital:
Prostaglandin analogues
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Travoprost
Pharmaceutical Solutions
Latanoprost
Ophthalmic Solutions
Antihypertensive Agents