Tolerability of Bimatoprost 0.01% vs Latanoprost Eye Drops

An observational study of Glaucoma, run by MDbackline, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study examines patient perceptions regarding the tolerability of two classes of glaucoma medication: bimatoprost and latanoprost. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma
How many people: 211 participants
Where: 1 siteUnited States
Study dates: Oct 2013to Sep 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients taking either study medication for glaucoma.

Who may be able to join

Patients with glaucoma taking either bimatoprost or latanoprost

Who cannot join

patients taking other medication or with other causes for ocular surface symptoms

Trial locations and contacts

1 site in 1 country.

United States1 site

Harvard Eye Associates
Laguna Hills, California, 92653

Other trials in United States

About this study

Official title: Subjective Patient Assessment Comparing Overall Tolerability and Satisfaction of a Prostaglandin Analogue Including Either Bimatoprost 0.01% or Latanoprost.

This study examines patient perceptions regarding the tolerability of two classes of glaucoma medication: bimatoprost and latanoprost.

Read the detailed description

Patients enrolled in this study completed a validated survey instrument (COMTOL) examining tolerability of topically applied ophthalmic medications that they are already taking in their regular course of care for glaucoma. The purpose of the study is to determine whether side effects and symptoms of the drugs already being taken cause problems with activities of daily living.

Conditions: Glaucoma
Keywords: glaucoma, bimatoprost, latanoprost, tolerability
Medical subject headings: Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02138461
Study group	Role	What they receive
bimatoprost		These patients take bimatoprost topically for glaucoma.
latanoprost group		These patients take latanoprost topically for glaucoma.

What is being measured

The primary outcome is the main question the study is designed to answer.

Tolerability of Medications as Measured by the COMTOL Validated Instrument
Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects.
Measured: at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Sep 2014

First posted14 May 2014 (estimated)
Study startOct 2013
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies 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: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 211 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02138461
Sponsor's protocol ID: JH-ALG-MDB-1301
Status last verified: Sep 2014
First submitted: 9 May 2014
Last updated: 25 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Subjective Patient Assessment Comparing Overall Tolerability and Satisfaction of a Prostaglandin Analogue Including Either Bimatoprost 0.01% or Latanoprost.
ClinicalTrials.gov ID: NCT02138461
Acronym / sponsor ID: JH-ALG-MDB-1301
Conditions: Glaucoma
Keywords: glaucoma, bimatoprost, latanoprost, tolerability
Study type: Observational
Recruitment status: Completed
Enrolment: 211 participants (actual)
Lead sponsor: MDbackline, LLCUniversity, hospital or other
Collaborators: Allergan
Study start: Oct 2013
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 14 May 2014 (estimated)
Results: Posted 25 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study examines patient perceptions regarding the tolerability of two classes of glaucoma medication: bimatoprost and latanoprost.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
bimatoprost	–	–These patients take bimatoprost topically for glaucoma.
latanoprost group	–	–These patients take latanoprost topically for glaucoma.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients taking either study medication for glaucoma.

Key inclusion criteria (1 listed)

Patients with glaucoma taking either bimatoprost or latanoprost

Key exclusion criteria (1 listed)

patients taking other medication or with other causes for ocular surface symptoms

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Tolerability of Medications as Measured by the COMTOL Validated Instrument
Time frame: at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study
Patients who are already taking the medications of interest will be enrolled from a general ophthalmology practice. Immediately after consenting to participate, they will complete a validated survey instrument called the Comparison of Ophthalmic Medication for Primary Outcome Measure Tolerability (COMTOL) questionnaire (Ophthalmology 1997; : 104:334-342). Because this study will not be a crossover trial design, and patients will only continue taking the medications they were prescribed in the course of their glaucoma therapy, the modified version will eliminate questions in the COMTOL related to subjective comparison of two medications and instead focus on tolerability of the single medication being taken by test subjects.

Results and safety

Results posted to the registry on 25 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Bimatoprost	101	101
Latanoprost Group	110	110

Primary outcome: Tolerability of Medications as Measured by the COMTOL Validated Instrument

Time frame: at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study. Number. Unit: percentage of patients

Measure	Bimatoprost n = 101	Latanoprost Group n = 110
Bothered by Itching More than "A Little"	23	50
Bothered by Burning/Stinging More Than "A Little"	26	29
Bothered by Redness More Than "A Little"	31	42
Bothered by Dry Eyes More Than "A Little"	47	54

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bimatoprost	0 of 101 (0%)	0 of 101 (0%)	Not reported
Latanoprost Group	0 of 110 (0%)	0 of 110 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

John A. Hovanesian, MD principal investigator

UCLA Jules Stein Eye Institute

Savak Teymoorian, MD principal investigator

Harvard Eye Associates

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Glaucoma, run by MDbackline, LLC at 1 site in United States.

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 1 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 25 Sep 2014. 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 United States. 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?

Yes. Results are posted in the registry (first posted 25 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Tolerability of Medications as Measured by the COMTOL Validated Instrument (time frame: at the time of enrollment in the clinic, patients will immediately complete the questionnaire and exit the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02138461.

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 25 Sep 2014.