GlaucomaIIIINCT04868175
Interval Intraocular Pressure in Intravitreal Injection Study
A study testing Timolol, Travatan and Hypromellose in people with Glaucoma and Intraocular Pressure, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective study of IOP in Intravitreal injections to evaluate: 1. IOP effect of intravitreal injection 2. IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods 3. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Glaucoma, Intraocular Pressure
- What is being tested?
- Timolol, Travatan and Hypromellose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2019to 1 Apr 2021
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AMD patients requiring multiple intravitreal injections (Eylea or Lucentis), not necessarily 3 month loading.
- Age >50
- Chinese patients with ability to read Chinese ICF
Who cannot join
- Known glaucoma
- Corneal disease e.g. corneal scarring or opacity preventing fundal view
- On steroid or anti glaucoma eye drops
- Prior vitrectomy or glaucoma surgery
- Recent intraocular surgery i.e. cataracts surgery
- Pseudophakic with anterior chamber IOL
Show all 10Show fewer
- History of ocular inflammatory disease e.g. uveitis
- Previous laser iridotomy
- Recent intravitreal injection of steroid
- Inability for regular follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Topical Beta Blocker and Prostaglandin on Interval Intraocular Pressure in Intravitreal Injection - a Randomised Controlled Prospective Study
This is a prospective study of IOP in Intravitreal injections to evaluate:
- IOP effect of intravitreal injection
- IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods
- IOP response in correlation to number of injections, IOL, type of anti VEGF, co morbidities
Read the detailed description
Study design: A prospective study Sample size: 60 patients (180 readings) Recruitment: Patients will be recruited at the intravitreal injection clinic in Grantham Hospital.
Randomization:
Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol
There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly.
Injection doctors masked to treatments given.
Study visits:
- Injection visit
- Record the anti-VFGF injection to be given
- Macula disease involved
- Record no. of previous injections
- Prophylactic eye drops will be given according to treatment group 1 hour prior injection
- IOP immediately before injection (without speculum while sitting on table)
- IOP immediately after injection (without speculum while sitting on table)
- IOP 30 minutes after injection via iCare
- Slitlamp examination, document inflammation or complications if any
- Day 1 follow-up visit
- IOP via iCare (sitting)
- Slitlamp examination, document inflammation or complications if any
- Week 1 follow-up visit
- IOP via iCare (sitting)
- Slitlamp examination, document inflammation or complications if any Visit a, b and c will be repeated for 2nd and 3rd injections.
- Conditions
- Glaucoma, Intraocular Pressure
- Being tested
- Timolol, Travatan, Hypromellose
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TimololDrug
Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production
TravatanDrug
Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow
HypromelloseDrug
Placebo eye drop, lubricant
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | control (hypromellose), then Timolol, then Travatan Receives: Drug: Timolol; Drug: Travatan; Drug: Hypromellose |
| Group 2 | Active comparator | Timolol, then Travatan, Hypromellose Receives: Drug: Timolol; Drug: Travatan; Drug: Hypromellose |
| Group 3 | Active comparator | Travatan, then Hypromellose, Timolol Receives: Drug: Timolol; Drug: Travatan; Drug: Hypromellose |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP effect of prophylactic IOP lowering eye drops over multiple time points
IOP in mmHg
Measured: From baseline to 30 minutes after injection
Secondary outcomes (3)
IOP effect of intravitreal injection
IOP in mmHg
Measured: From baseline to 30 minutes after injection
IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities
IOP in mmHg
Measured: From baseline to 30 minutes after injection
Inflammation to types of anti VEGF
presence of inflammation
Measured: 1 week post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Oct 2019
- Primary completion1 Mar 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly. Injection doctors masked to treatments given.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868175
- Sponsor's protocol ID
- IIII
- Acronym
- IIII
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Topical Beta Blocker and Prostaglandin on Interval Intraocular Pressure in Intravitreal Injection - a Randomised Controlled Prospective Study
- ClinicalTrials.gov ID
- NCT04868175
- Acronym / sponsor ID
- IIII / IIII
- Conditions
- Glaucoma, Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 30 Apr 2021 (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.
This is a prospective study of IOP in Intravitreal injections to evaluate:
- IOP effect of intravitreal injection
- IOP response to prophylactic beta blocker or Prostaglandin vs control (Hypromellose) over multiple time periods
- IOP response in correlation to number of injections, IOL, type of anti VEGF, co morbidities
Detailed description
Study design: A prospective study Sample size: 60 patients (180 readings) Recruitment: Patients will be recruited at the intravitreal injection clinic in Grantham Hospital.
Randomization:
Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol
There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly.
Injection doctors masked to treatments given.
Study visits:
- Injection visit
- Record the anti-VFGF injection to be given
- Macula disease involved
- Record no. of previous injections
- Prophylactic eye drops will be given according to treatment group 1 hour prior injection
- IOP immediately before injection (without speculum while sitting on table)
- IOP immediately after injection (without speculum while sitting on table)
- IOP 30 minutes after injection via iCare
- Slitlamp examination, document inflammation or complications if any
- Day 1 follow-up visit
- IOP via iCare (sitting)
- Slitlamp examination, document inflammation or complications if any
- Week 1 follow-up visit
- IOP via iCare (sitting)
- Slitlamp examination, document inflammation or complications if any Visit a, b and c will be repeated for 2nd and 3rd injections.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Group 1: control (hypromellose), then Timolol, then Travatan Group 2: Timolol, then Travatan, Hypromellose Group 3: Travatan, then Hypromellose, Timolol There are three groups of different treatments. Patients recruited will undergone all three groups of treatments. During the first injection visit, patients will be randomized (by envelope method upon recruitment) to start with one of the three groups by envelope method. Treatment given to each group according to randomization in the first visit, then rotated to second and third group at two subsequent injections accordingly. Injection doctors masked to treatments given.
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Timolol, Drug: Travatan, Drug: Hypromellosecontrol (hypromellose), then Timolol, then Travatan |
| Group 2 | Active comparator | Drug: Timolol, Drug: Travatan, Drug: HypromelloseTimolol, then Travatan, Hypromellose |
| Group 3 | Active comparator | Drug: Timolol, Drug: Travatan, Drug: HypromelloseTravatan, then Hypromellose, Timolol |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AMD patients requiring multiple intravitreal injections (Eylea or Lucentis), not necessarily 3 month loading.
- Age >50
- Chinese patients with ability to read Chinese ICF
Key exclusion criteria (10 listed)
- Known glaucoma
- Corneal disease e.g. corneal scarring or opacity preventing fundal view
- On steroid or anti glaucoma eye drops
- Prior vitrectomy or glaucoma surgery
- Recent intraocular surgery i.e. cataracts surgery
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 |
|---|---|---|
| TimololTopical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production | Drug | Group 1, Group 2, Group 3 |
| TravatanTopical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow | Drug | Group 1, Group 2, Group 3 |
| HypromellosePlacebo eye drop, lubricant | Drug | Group 1, Group 2, Group 3 |
Primary outcome
IOP effect of prophylactic IOP lowering eye drops over multiple time points
Time frame: From baseline to 30 minutes after injection
IOP in mmHg
3 secondary outcomes
IOP effect of intravitreal injection
Time frame: From baseline to 30 minutes after injection
IOP response to types of anti VEGF, IOL, type of anti VEGF and co-morbidities
Time frame: From baseline to 30 minutes after injection
Inflammation to types of anti VEGF
Time frame: 1 week post injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Timolol, Travatan and Hypromellose in people with Glaucoma and Intraocular Pressure, run by The University of Hong Kong at 1 site in Hong Kong.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 30 Apr 2021. 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 Hong Kong. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP effect of prophylactic IOP lowering eye drops over multiple time points (time frame: From baseline to 30 minutes after injection). 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 30 Apr 2021; AzTrials last refreshed its copy on 5 Nov 2026.