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

NCT04461249 | Completed DMC FDA Drug

• 1 other identifier: 411993
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open Angle Glaucoma

Keywords

Prostaglandin analogues

Outcome Measures

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

  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 Outcomes (1)

• To Compare Between the 3 drugs regarding their tolerability and assess their side effects.

  3 Months from starting the treatment

Study Arms (3)

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

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

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

Interventions

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.

Also known as: Xalatan

Latanoprost group

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.

Also known as: Travatan

Travoprost group

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.

Also known as: Saflutan

Tafluprost group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr El-Aini hospital

Cairo, Egypt

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Open-Angle

Interventions

Latanoprost; Ophthalmic Solutions; Travoprost; tafluprost

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Cloprostenol

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Ophthalmology

Study Record Dates

• First Submitted: June 27, 2020
• First Posted: July 8, 2020
• Study Start: June 1, 2019
• Primary Completion: February 28, 2020
• Study Completion: April 1, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

EG (1)