Effect of DrugPhase 4NCT05606796
Comparison of Preserved and Preservative-free Latanoprost 0.005% in Primary Open Angle Glaucoma and Ocular Hypertensive Patients, at Guinness Eye Centre, Lagos.
A Phase 4 study testing Latanoprost 0.005% Ophthalmic Solution in people with Effect of Drug, run by Uzoma Chinyei Joan at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Effect of Drug
- What is being tested?
- Latanoprost 0.005% Ophthalmic Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteNigeria
- Study dates
- Dec 2022to Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Guinness Eye Centre. Lagos University Teaching Hospital.
Lagos, Lagos, PMB 12003
ADEOLA ONAKOYA, FICO, MBBS,, +234807090401, adeolaonakoya@outlook.com
About this study
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.
Read the detailed description
Ethical approval has been obtained from the Health Research Ethics Committee of Lagos University Teaching Hospital.
Patients will be recruited from the weekly glaucoma clinic, Monday, Thursday, and Friday general clinics. Each participant would be seen for a period of 12 weeks; at baseline visit, and weeks 4, 8 and 12, in which topical, label-masked preserved or preservative free latanoprost would be dispensed, with patient instructed to instill one drop of 0.005% latanoprost by 9:00pm (± 1 hour). Efficacy of the two eye drops will be assessed by measuring the intraocular pressure 3 times a day at every visit. Safety and potential adverse effects of the drops will be evaluated in terms of ocular symptoms and tear parameters. Ocular symptom values of the patients will be evaluated.
All patients will undergo ocular examinations, including visual acuity assessment, slit lamp biomicroscopy, intraocular pressure, tear film breakup time (TBUT), fluorescein staining, schirmer test, gonioscopy, standard automated perimetry, and ophthalmoscopy. Tolerability will be evaluated with the frequency and percentage of distributions of severity level using the OSDI questionnaire in each group after administration at weeks 4 and 12, respectively. The symptoms checked during follow-up visits will include; pruritus, burning/stinging, blurred vision, tearing, sticky eye sensation, eye dryness sensation, and foreign body sensation. Quality of life would be evaluated at baseline visit and at week 12, using the standard quality of life Q-15 questionnaire.
A research team would be involved in carrying out this research, Comprising the principal researcher, a pharmacist, and 2 ophthalmic nurses. Results will be collated and analysed by the principal researcher. The entire research would be carried out over a period of 9 months, from December 2022 to August 2023.
- Conditions
- Effect of Drug
- Being tested
- Latanoprost 0.005% Ophthalmic Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Latanoprost 0.005% Ophthalmic SolutionDrug
1 drop of 0.005% Latanoprost (preserved or preservative-free) would be instilled into the conjunctival sac daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Latanoprost 0.005% Ophthalmic Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (2)
Ocular surface disease index (OSDI) questionnaire.
The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patient's responses are rated on a scale of 0 to 4, with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated, which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.
Measured: 4 weekly in 12 weeks.
Quality of life-15 questionnaire.
Questionnaire is composed of 15 items, 4 domains which address factors of visual disability: central and near vision, peripheral vision, dark adaptation and glare, and outdoor mobility. Poorer QoL scores are associated with worse functional status and increased visual morbidity from glaucoma
Measured: Baseline visit and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study startDec 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical control trial.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uzoma Chinyei Joan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Uzoma Chinyei Joan, University of Lagos, Nigeria
- Investigators
- ADEOLA ONAKOYA, MBBS, FMCOph, FICO, Principal investigator, Lagos State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606796
- Sponsor's protocol ID
- Chinyei
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Preserved and Preservative-free Latanoprost 0.005% in Primary Open Angle Glaucoma and Ocular Hypertensive Patients, at Guinness Eye Centre, Lagos.
- ClinicalTrials.gov ID
- NCT05606796
- Acronym / sponsor ID
- Chinyei
- Conditions
- Effect of Drug
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Uzoma Chinyei JoanUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Ethical approval has been obtained from the Health Research Ethics Committee of Lagos University Teaching Hospital.
Patients will be recruited from the weekly glaucoma clinic, Monday, Thursday, and Friday general clinics. Each participant would be seen for a period of 12 weeks; at baseline visit, and weeks 4, 8 and 12, in which topical, label-masked preserved or preservative free latanoprost would be dispensed, with patient instructed to instill one drop of 0.005% latanoprost by 9:00pm (± 1 hour). Efficacy of the two eye drops will be assessed by measuring the intraocular pressure 3 times a day at every visit. Safety and potential adverse effects of the drops will be evaluated in terms of ocular symptoms and tear parameters. Ocular symptom values of the patients will be evaluated.
All patients will undergo ocular examinations, including visual acuity assessment, slit lamp biomicroscopy, intraocular pressure, tear film breakup time (TBUT), fluorescein staining, schirmer test, gonioscopy, standard automated perimetry, and ophthalmoscopy. Tolerability will be evaluated with the frequency and percentage of distributions of severity level using the OSDI questionnaire in each group after administration at weeks 4 and 12, respectively. The symptoms checked during follow-up visits will include; pruritus, burning/stinging, blurred vision, tearing, sticky eye sensation, eye dryness sensation, and foreign body sensation. Quality of life would be evaluated at baseline visit and at week 12, using the standard quality of life Q-15 questionnaire.
A research team would be involved in carrying out this research, Comprising the principal researcher, a pharmacist, and 2 ophthalmic nurses. Results will be collated and analysed by the principal researcher. The entire research would be carried out over a period of 9 months, from December 2022 to August 2023.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized clinical control trial.
| Arm | Type | Receives |
|---|---|---|
| Preserved latanoprost | Experimental | Drug: Latanoprost 0.005% Ophthalmic SolutionBenzalkonium 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. |
| Preservative-free latanoprost | Experimental | Drug: Latanoprost 0.005% Ophthalmic SolutionPreservative-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. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Patients under 40 years of age.
- Diabetic patients
- Patients on other anti- glaucoma medications.
- Patients on topical immunosuppressive medication.
- Patients on anti-depressants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Latanoprost 0.005% Ophthalmic Solution1 drop of 0.005% Latanoprost (preserved or preservative-free) would be instilled into the conjunctival sac daily for 12 weeks. | Drug | Preservative-free latanoprost, Preserved latanoprost |
Primary outcome
Intraocular pressure assessment.
Time frame: 12 weeks
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.
2 secondary outcomes
Ocular surface disease index (OSDI) questionnaire.
Time frame: 4 weekly in 12 weeks.
Quality of life-15 questionnaire.
Time frame: Baseline visit and week 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ADEOLA ONAKOYA, MBBS, FMCOph, FICO principal investigator
Lagos State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Latanoprost 0.005% Ophthalmic Solution in people with Effect of Drug, run by Uzoma Chinyei Joan at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uzoma C Joan, MBBS (+2348033336844, chinyuzoma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure assessment. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.