HealthyPhase 2NCT02214680
The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter
A Phase 2 study testing Combigan (Combination of Brimonidine and Timolol) and Timolol in people with Healthy, run by Carmel Medical Center at 1 site in Israel.
Trial summary
In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan) eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic effect on the pupil, however the combined effect of alpha agonist and beta blocker has not been studied. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Combigan (Combination of Brimonidine and Timolol) and Timolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2015to Dec 2016
- Phase
- Phase 2
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults subjects with no ocular pathology
- Non pregnant women
- Normal pupil response
Who cannot join
- Chronic topical treatment
- Systemic medication affecting autonomic nerve system
- History of intra-ocular surgery
- Irregular pupil
- History of ocular neurological or severe cardio-vascular disease
Trial locations and contacts
1 site in 1 country.
Israel1 site
Carmel Medical Center
Haifa, 34362
Zina Goldbaum, 97248250441, zinago@clalit.org.il
About this study
In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan) eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic effect on the pupil, however the combined effect of alpha agonist and beta blocker has not been studied.
Read the detailed description
In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan) eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic effect on the pupil, however the combined effect of alpha agonist and beta blocker has not been studied.
The study subjects will be examined twice, two weeks apart. On the first exam the subject will receive Combigan eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.
- Conditions
- Healthy
- Being tested
- Combigan (Combination of Brimonidine and Timolol), Timolol
- Keywords
- Pupil diameter, Brimonidine, Timolol, Combigan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combigan (Combination of Brimonidine and Timolol)Drug
Also called Alphagan, Tiloptic, Combigan
On the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.
TimololDrug
Also called Tiloptic
0.5% eye drop
| Study group | Role | What they receive |
|---|---|---|
| Combination of Brimonidine and Timolol | Experimental | On the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. Receives: Drug: Combigan (Combination of Brimonidine and Timolol); Drug: Timolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupil diameter
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startOct 2015
- Primary completionAug 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orna Geyer, Carmel Medical Center
- Investigators
- Orna Geyer, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214680
- Sponsor's protocol ID
- CMC-14-0016-CTIL
- Other IDs
- CMC-14-0016
- Status last verified
- Oct 2015
- First submitted
- 11 Aug 2014
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Topical Treatment With Combigan Compared to Timolol and Brimonidine on Pupil Diameter
- ClinicalTrials.gov ID
- NCT02214680
- Acronym / sponsor ID
- CMC-14-0016-CTIL
- Conditions
- Healthy
- Keywords
- Pupil diameter, Brimonidine, Timolol, Combigan
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 12 Aug 2014 (estimated)
- 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.
In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan) eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic effect on the pupil, however the combined effect of alpha agonist and beta blocker has not been studied.
Detailed description
In this study we will explore the combined effect of Brimonidine and Timolol 0.5% (Combigan) eye drops on pupil dilation. It is a well studied phenoma that Brimonidine and a miotic effect on the pupil, however the combined effect of alpha agonist and beta blocker has not been studied.
The study subjects will be examined twice, two weeks apart. On the first exam the subject will receive Combigan eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination of Brimonidine and Timolol | Experimental | Drug: Combigan (Combination of Brimonidine and Timolol), Drug: TimololOn the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy adults subjects with no ocular pathology
- Non pregnant women
- Normal pupil response
Key exclusion criteria (5 listed)
- Chronic topical treatment
- Systemic medication affecting autonomic nerve system
- History of intra-ocular surgery
- Irregular pupil
- History of ocular neurological or severe cardio-vascular disease
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 |
|---|---|---|
| Combigan (Combination of Brimonidine and Timolol)Also: Alphagan, Tiloptic, CombiganOn the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. | Drug | Combination of Brimonidine and Timolol |
| TimololAlso: Tiloptic0.5% eye drop | Drug | Combination of Brimonidine and Timolol |
Primary outcome
Pupil diameter
Time frame: two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
Orna Geyer, MD principal investigator
Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Combigan (Combination of Brimonidine and Timolol) and Timolol in people with Healthy, run by Carmel Medical Center at 1 site in Israel.
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 5 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 14 Oct 2015. 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 Israel. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Orna Geyer, Professor (97248250926, orna_geyer@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupil diameter (time frame: two 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 14 Oct 2015.