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OpenTrials
Completed

NCT Number: NCT04461249

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

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.

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Key information

Conditions

Primary Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kasr El-Aini hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Latanoprost 0.005% Ophthalmic Solution

Drug

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 names: Xalatan

Travoprost 0.004% ophthalmic solution

Drug

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 names: Travatan

Tafluprost Ophthalmic 0.0015% Ophthalmic Solution

Drug

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 names: Saflutan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 8, 2020
Registry last updated
Jul 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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