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

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.

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma
• Intervention / Treatment: Drug: Latanoprost 0.005% Ophthalmic Solution; Drug: Travoprost 0.004% ophthalmic solution; Drug: Tafluprost Ophthalmic 0.0015% Ophthalmic Solution

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr El-Aini Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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 Names: 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 Names: 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 Names: Saflutan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months from starting the treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 Months from starting the treatment

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: June 27, 2020
• First Submitted That Met QC Criteria: July 3, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 3, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Prostaglandin analogues
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle; Antihypertensive Agents; Ophthalmic Solutions; Pharmaceutical Solutions; Travoprost; Latanoprost
• Other Study ID Numbers: 411993

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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