Drug Effect (Glaucoma Drugs)pupilNCT02522039
Pupillary Response After Glaucoma Medication
A study testing Latanoprost, Timolol and Dorzolamide in people with Drug Effect (Glaucoma Drugs), run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol in healthy subjects. The pupillary constriction is compared to no drug. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Effect (Glaucoma Drugs)
- What is being tested?
- Latanoprost, Timolol and Dorzolamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Nov 2014
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subjects
Who cannot join
- ophthalmological diseases
- systemic disease
- smoking
- refractive error >= 6 diopters
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Topical Anti-glaucoma Medications on Late Pupillary Light Reflex, as Evaluated by Pupillometry
Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol in healthy subjects. The pupillary constriction is compared to no drug.
- Conditions
- Drug Effect (Glaucoma Drugs)
- Being tested
- Latanoprost, Timolol, Dorzolamide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LatanoprostDrug
1 drop of latanoprost was given to study eye after washout period of 1 week between drugs
TimololDrug
Also called Optimol
1 drop of timolol was given to study eye after washout period of 1 week between drugs
DorzolamideDrug
1 drop of dorzolamide was given to study eye after washout period of 1 week between drugs
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost | Experimental | solution, 1 drop of 50ug/ml latanoprost, was given to study eye after washout period of 1 week between drugs Receives: Drug: Latanoprost |
| Timolol | Experimental | solution, 1 drop of 5mg/ml timolol , was given to study eye after washout period of 1 week between drugs Receives: Drug: Timolol |
| dorzolamide | Experimental | solution, 1 drop of 20 mg/ml dorzolamide, was given to study eye after washout period of 1 week between drugs Receives: Drug: Dorzolamide |
| Other | No intervention | no drug given and pupil measurements were performed before and at 30 and 180 min at equivalent hours as drugs measurements |
What is being measured
The primary outcome is the main question the study is designed to answer.
pupillary constriction measured as the post-illimination pupillay response (PIPR)
The pupillary diameter 0 to 10 seconds after light stimulation, the diameter is measured relative to the initial dark adapted pupil diameter
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMay 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Effect (Glaucoma Drugs)Studies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birgit Sander, Glostrup University Hospital, Copenhagen
- Investigators
- Henrik Lund-Andersen, Professor, Study director, Head of the project
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522039
- Sponsor's protocol ID
- GlostrupUH
- Acronym
- pupil
- Status last verified
- Aug 2015
- First submitted
- 14 Nov 2014
- Last updated
- 13 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Topical Anti-glaucoma Medications on Late Pupillary Light Reflex, as Evaluated by Pupillometry
- ClinicalTrials.gov ID
- NCT02522039
- Acronym / sponsor ID
- pupil / GlostrupUH
- Conditions
- Drug Effect (Glaucoma Drugs)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 13 Aug 2015 (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.
Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol in healthy subjects. The pupillary constriction is compared to no drug.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Latanoprost | Experimental | Drug: Latanoprostsolution, 1 drop of 50ug/ml latanoprost, was given to study eye after washout period of 1 week between drugs |
| Timolol | Experimental | Drug: Timololsolution, 1 drop of 5mg/ml timolol , was given to study eye after washout period of 1 week between drugs |
| dorzolamide | Experimental | Drug: Dorzolamidesolution, 1 drop of 20 mg/ml dorzolamide, was given to study eye after washout period of 1 week between drugs |
| Other | No intervention | –no drug given and pupil measurements were performed before and at 30 and 180 min at equivalent hours as drugs measurements |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy subjects
Key exclusion criteria (4 listed)
- ophthalmological diseases
- systemic disease
- smoking
- refractive error >= 6 diopters
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 |
|---|---|---|
| Latanoprost1 drop of latanoprost was given to study eye after washout period of 1 week between drugs | Drug | Latanoprost |
| TimololAlso: Optimol1 drop of timolol was given to study eye after washout period of 1 week between drugs | Drug | Timolol |
| Dorzolamide1 drop of dorzolamide was given to study eye after washout period of 1 week between drugs | Drug | dorzolamide |
Primary outcome
pupillary constriction measured as the post-illimination pupillay response (PIPR)
Time frame: 1 day
The pupillary diameter 0 to 10 seconds after light stimulation, the diameter is measured relative to the initial dark adapted pupil diameter
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 13 Aug 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.
Henrik Lund-Andersen, Professor study director
Head of the project
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Latanoprost, Timolol and Dorzolamide in people with Drug Effect (Glaucoma Drugs), run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 1 inclusion and 4 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 13 Aug 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 Denmark. 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?
pupillary constriction measured as the post-illimination pupillay response (PIPR) (time frame: 1 day). 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 13 Aug 2015.