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

Completed

• Conditions: Primary Open Angle Glaucoma
• Interventions: Drug: Travoprost 0.004% ophthalmic solution; Drug: Tafluprost Ophthalmic 0.0015% Ophthalmic Solution; Drug: Latanoprost 0.005% Ophthalmic Solution

• Registration Number: NCT04461249
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2020-02-28
• Study Completion: 2020-04-01
• Study First Submitted: 2020-06-27
• Status Verified: 2020-07
• Study First Submitted QC: 2020-07-03
• Last Update Submitted: 2020-07-03
• Study First Posted: 2020-07-08
• Last Update Posted: 2020-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Travoprost group	Travoprost 0.004% ophthalmic solution	Travoprost 0.004 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.
Tafluprost group	Tafluprost Ophthalmic 0.0015% Ophthalmic Solution	Tafluprost 0.0015 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.
Latanoprost group	Latanoprost 0.005% Ophthalmic Solution	Latanoprost 0.005 % eye drops was given once by night for 3 months for newly diagnosed primary open-angle glaucoma patients.

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
To Compare Between the 3 drugs regarding their tolerability and assess their side effects.	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

Trial Locations

Locations (1)

Kasr El-Aini hospital; 🇪🇬 Cairo, Egypt