Study to Determine if Taking OTC Non-Steroidal Anti-Inflammatory Affects Eye Pressure in Patients Using Glaucoma Drops
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00402493 |
Recruitment Status :
Completed
First Posted : November 22, 2006
Last Update Posted : April 4, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glaucoma Ocular Hypertension | Drug: ibuprofen, latanoprost, brimonidine Drug: Ibuprofen, brimonidine, latanoprost Drug: Ibuprofen | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 51 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
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. |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Latanoprost
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
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Drug: ibuprofen, latanoprost, brimonidine
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
Other Name: placebo Drug: Ibuprofen, brimonidine, latanoprost 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
Other Name: ibuprofen 200mg, and placebo pills |
Active Comparator: Brimonidine
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
|
Drug: ibuprofen, latanoprost, brimonidine
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
Other Name: placebo Drug: Ibuprofen, brimonidine, latanoprost 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
Other Name: ibuprofen 200mg, and placebo pills |
Active Comparator: ibuprofen
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
|
Drug: ibuprofen, latanoprost, brimonidine
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
Other Name: placebo Drug: Ibuprofen ibuprofen 200mg
Other Name: ibuprofen 200mg |

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00402493
United States, New Jersey | |
Philadelphia Eye Associates | |
Willingboro, New Jersey, United States, 08046 | |
United States, Pennsylvania | |
Philadelphia Eye Associates | |
Philadelphia, Pennsylvania, United States, 19134 | |
Philadelphia Eye Associates | |
Philadelphia, Pennsylvania, United States, 19148 |
Principal Investigator: | Joseph I. Markoff, Ph.D,M.D | Philadelphia Eye Associates |
Responsible Party: | Philadelphia Eye Associates |
ClinicalTrials.gov Identifier: | NCT00402493 |
Other Study ID Numbers: |
GA6110HV |
First Posted: | November 22, 2006 Key Record Dates |
Last Update Posted: | April 4, 2018 |
Last Verified: | September 2017 |
Glaucoma Ocular Hypertension Xalatan Alpahgan Ibuprofen |
Non-Steroidal Anti-Inflammatory Brimonidine Latanoprost Eye Pressure Intra-Ocular Pressure |
Glaucoma Ocular Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Ibuprofen Brimonidine Tartrate Latanoprost Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Ophthalmic Solutions Pharmaceutical Solutions Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents |