Comparison of Preserved and Preservative-free Latanoprost 0.005% in Primary Open Angle Glaucoma and Ocular Hypertensive Patients, at Guinness Eye Centre, Lagos.

NCT05606796 | Unknown Phase 4 DMC

• 1 other identifier: Chinyei
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomised, double-blinded clinical trial in which consenting participants who meet the inclusion criteria would be randomised into 2 groups. Subjects will be given either preserved or preservative free latanoprost for a period of 12 weeks. The efficacy and tolerability of both drugs would be assessed every 4 weeks, amongst these patients.

Conditions

Effect of Drug

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure assessment.

  Intraocular pressure measured in millimetre mercury (mmHg), will be assessed every 4 weeks at 8am,12pm and 4pm. Normal intraocular pressure ranges between 9 to 21mmHg. Any intraocular pressure values above 21mmHg would be considered abnormal. Pressures below 6mmHg will be considered as hypotony.

  12 weeks

Secondary Outcomes (2)

• Ocular surface disease index (OSDI) questionnaire.

  4 weekly in 12 weeks.

• Quality of life-15 questionnaire.

  Baseline visit and week 12.

Study Arms (2)

Preserved latanoprost

EXPERIMENTAL

Benzalkonium chloride (BAK) preserved latanoprost 0.005%. 1 drop will be instilled into the conjunctival sac of both eyes of patient, at about 9pm daily, to reduce intraocular pressure.

Drug: Latanoprost 0.005% Ophthalmic Solution

Preservative-free latanoprost

EXPERIMENTAL

Preservative-free (Benzalkonium chloride-free) latanoprost 0.005%. 1 drop will be instilled into the conjunctival sac of both eyes of patient, at about 9pm daily, to reduce intraocular pressure.

Drug: Latanoprost 0.005% Ophthalmic Solution

Interventions

Latanoprost 0.005% Ophthalmic Solution DRUG

1 drop of 0.005% Latanoprost (preserved or preservative-free) would be instilled into the conjunctival sac daily for 12 weeks.

Preservative-free latanoprost; Preserved latanoprost

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recently diagnosed, consenting high tension, primary open angle glaucoma or ocular hypertensive patients.
• Forty years and above.
• Intraocular pressure of 21- 30mmHg (millimetres of mercury)
• Willingness to participate in the study.

You may not qualify if:

• Patients under 40 years of age.
• Diabetic patients
• Patients on other anti- glaucoma medications.
• Patients on topical immunosuppressive medication.
• Patients on anti-depressants.
• Patients who have had any form of ocular surgery or intervention such as cryotherapy.
• Patients using contact lens.
• Patients on any form of topical medication in the last 1 month.
• Patients diagnosed or suspected to have Sjogren syndrome.
• Patients being managed for Steven-Johnson's syndrome, ocular cicatricial pemphigoid.
• Pregnant patients.
• Previous glaucoma surgery and any refractive surgery \<12 month prior to enrolment.
• Only eye patients.

Sponsors & Collaborators

• Uzoma Chinyei Joan: lead

Study Sites (1)

Guinness Eye Centre. Lagos University Teaching Hospital.

Lagos, Lagos, PMB 12003, Nigeria

RECRUITING

MeSH Terms

Interventions

Latanoprost; Ophthalmic Solutions

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

Study Officials

• ADEOLA ONAKOYA, MBBS, FMCOph, FICO

  Lagos State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Uzoma C Joan, MBBS

CONTACT

+2348033336844; chinyuzoma@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both preserved and preservative-free drugs would be masked from the patient and the principal researcher. The pharmacist would remove actual labels, and mask them with new labels, coded ''X'' and ''Y'' latanoprost 0.005%, representing either preserved or preservative free medications, known to only the pharmacist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: Randomized clinical control trial.

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 7, 2022
• Study Start: December 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

NG (1)