GlaucomaNCT00402493
Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops
A study testing ibuprofen, latanoprost, brimonidine, Ibuprofen, brimonidine, latanoprost and Ibuprofen in people with Glaucoma and Ocular Hypertension, run by Philadelphia Eye Associates at 3 sites in United States.
Trial summary
The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- ibuprofen, latanoprost, brimonidine, Ibuprofen, brimonidine, latanoprost and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2006to Mar 2008
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with bilateral or unilateral primary open angle glaucoma or ocular hypertension
- An IOP in each eye of greater than 22mm HG after washout of IOP lowering medications
- No worse than 20/200 best corrected visual acuity
- Normal appearing or non-occludable anterior chamber angles
- Discontinuation of current POAG or OH medications before participation in the study.
- Written Informed Consent
Who cannot join
- Use of any other ocular medications
- Previous ocular surgery or laser therapy within the last three months.
- Systemic treatment with any adrenergic agonist or antagonist, corticosteroid or nonsteroidal anti-inflammatory agents(low dose apsirin will be accepted if dose remains the same for entire study period).
- An age of less than 21,of child bearing age and currently pregnant, considering pregnancy or a nursing mother.
- A history of medical noncompliance or unreliability.
- Presence of uncontrolled hypertension, cardiac arrhythmia, cerebrovascular accident, nasal polyps, bleeding diathesis, peptic ulcer disease, gastritis or known intolerance, contraindication or allergy to any drugs used in the study.
- Lactose Intolerance.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19134
Philadelphia Eye Associates
Philadelphia, Pennsylvania, 19148
Philadelphia Eye Associates
Willingboro, New Jersey, 08046
About this study
Official title: A Prospective,Randomized,Masked,Study to Evaluate the Interaction of Non-Steroidal Anti-Inflammatory Agent With IOP-Lowering Effect of Brimonidine or Latanoprost.
The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
Read the detailed description
Topical IOP-lowering therapy has the advantage of providing a drug level directly to the end organ with very little or no systemic absorption thereby reducing side effect potential. There is very little information in the ophthalmic literature regarding potential drug interactions between topical IOP-lowering medications and other medications taken orally for other medical reasons. Patients will be randomized to either latanoprost or brimonidine. Patients in both groups will be randomized to either placebo or ibuprofen for the first 14 days and then crossed over to the other treatment for 14 days.
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- ibuprofen, latanoprost, brimonidine, Ibuprofen, brimonidine, latanoprost, Ibuprofen
- Keywords
- Glaucoma, Ocular Hypertension, Xalatan, Alpahgan, Ibuprofen, Non-Steroidal Anti-Inflammatory, Brimonidine, Latanoprost, Eye Pressure, Intra-Ocular Pressure
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofen, latanoprost, brimonidineDrug
Also called placebo
to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure
Ibuprofen, brimonidine, latanoprostDrug
Also called ibuprofen 200mg, and placebo pills
to determine whether commonly used OTC non-steroidal anti-inflammatory agentsn(200mg ibuprofen) taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure
IbuprofenDrug
Also called ibuprofen 200mg
ibuprofen 200mg
| Study group | Role | What they receive |
|---|---|---|
| Latanoprost | Active comparator | to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure Receives: Drug: ibuprofen, latanoprost, brimonidine; Drug: Ibuprofen, brimonidine, latanoprost |
| Brimonidine | Active comparator | to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure Receives: Drug: ibuprofen, latanoprost, brimonidine; Drug: Ibuprofen, brimonidine, latanoprost |
| ibuprofen | Active comparator | to determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure Receives: Drug: ibuprofen, latanoprost, brimonidine; Drug: Ibuprofen |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionMar 2008
- Study completionMar 2008
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philadelphia Eye Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Joseph I. Markoff, Ph.D,M.D, Principal investigator, Philadelphia Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402493
- Sponsor's protocol ID
- GA6110HV
- Status last verified
- Sep 2017
- First submitted
- 20 Nov 2006
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective,Randomized,Masked,Study to Evaluate the Interaction of Non-Steroidal Anti-Inflammatory Agent With IOP-Lowering Effect of Brimonidine or Latanoprost.
- ClinicalTrials.gov ID
- NCT00402493
- Acronym / sponsor ID
- GA6110HV
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- Glaucoma, Ocular Hypertension, Xalatan, Alpahgan, Ibuprofen, Non-Steroidal Anti-Inflammatory, Brimonidine, Latanoprost
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Philadelphia Eye AssociatesUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Dec 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 22 Nov 2006 (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.
The Purpose of This Study is to Determine if Taking an Over the Counter Non-Steroidal Anti-Inflammatory(Ibuprofen)has an Effect on Eye Pressure in Patients using Brimonidine(Alphagan)and Latanoprost(Xalatan) eye drops.
Detailed description
Topical IOP-lowering therapy has the advantage of providing a drug level directly to the end organ with very little or no systemic absorption thereby reducing side effect potential. There is very little information in the ophthalmic literature regarding potential drug interactions between topical IOP-lowering medications and other medications taken orally for other medical reasons. Patients will be randomized to either latanoprost or brimonidine. Patients in both groups will be randomized to either placebo or ibuprofen for the first 14 days and then crossed over to the other treatment for 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Latanoprost | Active comparator | Drug: ibuprofen, latanoprost, brimonidine, Drug: Ibuprofen, brimonidine, latanoprostto determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure |
| Brimonidine | Active comparator | Drug: ibuprofen, latanoprost, brimonidine, Drug: Ibuprofen, brimonidine, latanoprostto determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure |
| ibuprofen | Active comparator | Drug: ibuprofen, latanoprost, brimonidine, Drug: Ibuprofento determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with bilateral or unilateral primary open angle glaucoma or ocular hypertension
- An IOP in each eye of greater than 22mm HG after washout of IOP lowering medications
- No worse than 20/200 best corrected visual acuity
- Normal appearing or non-occludable anterior chamber angles
- Discontinuation of current POAG or OH medications before participation in the study.
Key exclusion criteria (7 listed)
- Use of any other ocular medications
- Previous ocular surgery or laser therapy within the last three months.
- Systemic treatment with any adrenergic agonist or antagonist, corticosteroid or nonsteroidal anti-inflammatory agents(low dose apsirin will be accepted if dose remains the same for entire study period).
- An age of less than 21,of child bearing age and currently pregnant, considering pregnancy or a nursing mother.
- A history of medical noncompliance or unreliability.
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 |
|---|---|---|
| ibuprofen, latanoprost, brimonidineAlso: placeboto determine whether commonly used OTC non-steroidal anti-inflammatory agents taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure | Drug | Brimonidine, Latanoprost, ibuprofen |
| Ibuprofen, brimonidine, latanoprostAlso: ibuprofen 200mg, and placebo pillsto determine whether commonly used OTC non-steroidal anti-inflammatory agentsn(200mg ibuprofen) taken orally has any effect on the ability of either latanoprost or brimonidine to lower high eye pressure | Drug | Brimonidine, Latanoprost |
| IbuprofenAlso: ibuprofen 200mgibuprofen 200mg | Drug | ibuprofen |
Primary outcome
Not reported in the source record.
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 4 Apr 2018.
Related trials for Glaucoma
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
AI-Assisted vs Conventional Teleglaucoma Referral
Glaucoma
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
Recruiting
Automated Applanation Tonometry - Updated
Glaucoma, Glaucoma, Suspect
RecruitingPhase 2
A Phase 2a Study Comparing the Efficacy, Safety and Tolerability of Pregabalin Eye Drops Comparing With Timolol Eye Drops in Adults With Glaucoma or High Eye Pressure.
Primary Open - Angle Glaucoma (POAG), Ocular Hypertension (OHT)
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.
Joseph I. Markoff, Ph.D,M.D principal investigator
Philadelphia Eye Associates
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ibuprofen, latanoprost, brimonidine, Ibuprofen, brimonidine, latanoprost and Ibuprofen in people with Glaucoma and Ocular Hypertension, run by Philadelphia Eye Associates at 3 sites 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 6 inclusion and 7 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 4 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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.
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 4 Apr 2018.