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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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To determine whether one glaucoma eye drop is less likely to cause changes to the surface of the eye (conjunctiva) than another. The two different prostaglandins are Xalatan and Travatan Z.
Two groups will be entered into this study: group 1 will be naive to treatment and group 2 will be using Xalatan for at least one month before enrollment. Both groups will be using one drop at bedtime of Xalatan in the right eye and one drop at bedtime of Travatan Z in the left eye. Both of these drops are presently on the market and approved by the FDA for treatment of lowering eye pressure. Because this study will be masked, the examining clinician will not know what study drop each patient has been using.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New to Meds | Other | Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. |
|
| Currently on Xalatan | Other | Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xalatan | Drug | one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Tear Break up Time (TBUT) | Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment. | Baseline, 1 month, 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Tear Production | Tear production, measured by Schirmer test in millimeters | Baseline, 1 month, 2 months |
| Conjunctival Hyperemia Score | Conjunctival hyperemia is the amount of redness on the white part of the eye. A total score was obtained by the sum of assessments in 6 areas of each eye are which are scored from 0 to 3 (0 = no redness; 3 = severe redness), then summed per eye for a total score range of 0-18 (0 = no redness; 18 = severe redness). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie J Katz, MD | Wills Eye Glaucoma Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wills Eye Glaucoma Service | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Gupta SR, Ichhpujani P, Wizov SS, Wittpenn JR, Moster MR, Pro MJ, Rapuano CJ, Cruz-Colon C, Myers JS, Katz LJ. Effects of Latanoprost Versus Travoprost with Sofzia on Ocular Surface. ARVO E-abstract 168/A391 2010 | ||
| 28617732 | Result | Rahmatnejad K, Rapuano CJ, Ichhpujani P, Wizov SS, Moster MR, Hark LA, Katz LJ. The Effects of Latanoprost With Benzalkonium Chloride Versus Travoprost With SofZia on the Ocular Surface. Eye Contact Lens. 2018 Nov;44 Suppl 2:S93-S98. doi: 10.1097/ICL.0000000000000405. |
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A manuscript has been published.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 (New to Meds) | Naive to glaucoma therapy medical or surgical. These patients have never used eye drops to lower eye pressure. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime |
| FG001 | Group 2 (Currently on Xalatan) | Patients currently on Xalatan at least one month. These patients have been using Xalatan at least one month to lower their eye pressure. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
58 patients were enrolled. 2 patients did not return for follow-up and 1 patient's intraocular pressure was not controlled adequately on one eye drop. That patient was discontinued when a second eye drop was added to lower their eye pressure.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 (New to Meds) | Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Tear Break up Time (TBUT) | Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment. | Both eyes combined change from baseline. | Posted | Mean | Standard Deviation | seconds | Baseline, 1 month, 2 months |
|
Baseline, 1 month, 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | New to Meds | Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime |
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Small sample size. Short term study may not reflect long term ocular surface. Patients selected were free of baseline Ocular Surface Disease (OSD). Sample population with pre-existing OSD may have different sensitivity.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator | Wills Eye Hospital | 215-928-3197 | ljaykatz@gmail.com |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| D011465 | Prostaglandins, Synthetic |
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
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Doctors assessing patients were masked to treatment. Patients used open label Xalantan in the right eye and Travatan Z in the left eye.
| Travatan Z | Drug | one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime |
|
|
| Baseline, 1 month, 2 months |
| Intraocular Pressure | Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged. | Baseline, 1 month, 2 months |
| Ocular Surface Disease Index Score | Ocular Surface Disease Index Scores (OSDI) were obtained from a 12-item validated OSDI questionnaire completed by each participant. This is an assessment related to eye comfort. Each question's score ranges from 0 = no disability to 4 = greatest disability. The total score is multiplied by 25 then divided by the number of questions answered then matched to a grid ranging from 0 to 100 with 0 having symptoms reported none of the time versus 100 having disability symptoms reported all of the time. | Baseline, 1 month, 2 months |
| Corneal Staining Score | Corneal staining is an indication of the amount of dryness of the cornea (front clear part of the eye). A total score was obtained by the sum of assessments in five areas of each eye which are scored from 0 to 3 (0 = no dryness; 3 = severe dryness), then summed per eye for a total score range of 0-15 (0 = no dryness; 15 = severe dryness). | Baseline, 1 month, 2 months |
| Group 2 (Currently on Xalatan) |
Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime |
|
|
|
| Secondary | Tear Production | Tear production, measured by Schirmer test in millimeters | Posted | Mean | Standard Deviation | millimeters | Baseline, 1 month, 2 months |
|
|
|
| Secondary | Conjunctival Hyperemia Score | Conjunctival hyperemia is the amount of redness on the white part of the eye. A total score was obtained by the sum of assessments in 6 areas of each eye are which are scored from 0 to 3 (0 = no redness; 3 = severe redness), then summed per eye for a total score range of 0-18 (0 = no redness; 18 = severe redness). | One eye per participant in each Arm | Posted | Mean | Standard Deviation | units on a scale | Baseline, 1 month, 2 months |
|
|
|
| Secondary | Intraocular Pressure | Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged. | Posted | Mean | Standard Deviation | mmHg | Baseline, 1 month, 2 months |
|
|
|
| Secondary | Ocular Surface Disease Index Score | Ocular Surface Disease Index Scores (OSDI) were obtained from a 12-item validated OSDI questionnaire completed by each participant. This is an assessment related to eye comfort. Each question's score ranges from 0 = no disability to 4 = greatest disability. The total score is multiplied by 25 then divided by the number of questions answered then matched to a grid ranging from 0 to 100 with 0 having symptoms reported none of the time versus 100 having disability symptoms reported all of the time. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 1 month, 2 months |
|
|
|
| Secondary | Corneal Staining Score | Corneal staining is an indication of the amount of dryness of the cornea (front clear part of the eye). A total score was obtained by the sum of assessments in five areas of each eye which are scored from 0 to 3 (0 = no dryness; 3 = severe dryness), then summed per eye for a total score range of 0-15 (0 = no dryness; 15 = severe dryness). | One eye from each patient per arm. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, 1 month, 2 months |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Currently on Xalatan | Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. Xalatan: one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime Travatan Z: one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime | 0 | 28 | 0 | 28 | 0 | 28 |
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| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D003008 | Cloprostenol |
| 2 months |
|
| 1 month |
|
| 2 months |
|
| 1 month |
|
| 2 months |
|
| 1 month |
|
| 2 months |
|
| 1 month |
|
| 2 months |
|