Glaucoma
Conditions
Keywords
glaucoma, impression cytology, ocular surface changes, prostaglandins
Brief summary
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.
Detailed description
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.
Interventions
DRUGXalatan
one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
DRUGTravatan Z
one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
Sponsors
Pfizer
Wills Eye
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Doctors assessing patients were masked to treatment. Patients used open label Xalantan in the right eye and Travatan Z in the left eye.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 21 or older * Able to understand protocol and agree to 3 visits * Any type of glaucoma * Selective laser trabeculoplasty, Argon laser trabeculoplasty, peripheral iridotomy accepted * Naïve: No prior glaucoma treatment (medical or surgical) * If patient non-compliant, must be off meds 3 months * Xalatan: At least one month use
Exclusion criteria
* Both Groups: Any history of ocular surface disease * Dry eye syndrome or prior Restasis use * Prior ocular surgery other than cataract extractions * Uveitis or other inflammatory disease of the eye or adnexa * Systemic medications that might influence ocular inflammation * Any active inflammation or infection * Pregnancy or intention to become pregnant * Naïve: Prior use of topical glaucoma medication unless off for 3 months. * Use of preserved artificial tear preparations in last 30 days and more than one year history of chronic use * Xalatan: Prior use of Travatan or Travatan Z
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Tear Break up Time (TBUT) | Baseline, 1 month, 2 months | Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear Production | Baseline, 1 month, 2 months | Tear production, measured by Schirmer test in millimeters |
| Conjunctival Hyperemia Score | Baseline, 1 month, 2 months | 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). |
| Intraocular Pressure | Baseline, 1 month, 2 months | Intraocular pressure (the fluid pressure inside the eye) was measured two times in each eye using the Goldman applanation tonometer and averaged. |
| Ocular Surface Disease Index Score | Baseline, 1 month, 2 months | 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. |
| Corneal Staining Score | Baseline, 1 month, 2 months | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 28 |
| 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 | 27 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Group 1 (New to Meds) | Group 2 (Currently on Xalatan) | Total |
|---|---|---|---|
| Age, Continuous | 61.6 years STANDARD_DEVIATION 11.7 | 61.2 years STANDARD_DEVIATION 13.2 | 61.4 years STANDARD_DEVIATION 12.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 25 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 15 Participants | 17 Participants | 32 Participants |
| Region of Enrollment United States | 28 participants | 27 participants | 55 participants |
| Sex: Female, Male Female | 13 Participants | 16 Participants | 29 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 28 |
| other Total, other adverse events | 0 / 30 | 0 / 28 |
| serious Total, serious adverse events | 0 / 30 | 0 / 28 |
Outcome results
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.
Time frame: Baseline, 1 month, 2 months
Population: Both eyes combined change from baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New to Meds | Change in Tear Break up Time (TBUT) | 1 month | -0.86 seconds | Standard Deviation 6.09 |
| New to Meds | Change in Tear Break up Time (TBUT) | 2 months | -2.00 seconds | Standard Deviation 5.42 |
| Currently on Xalatan | Change in Tear Break up Time (TBUT) | 1 month | -0.59 seconds | Standard Deviation 4.7 |
| Currently on Xalatan | Change in Tear Break up Time (TBUT) | 2 months | 0.27 seconds | Standard Deviation 4.72 |
Comparison: Null Hypothesis: There is no significant difference in tear break-up time between the group New to Meds and the group Currently on Xalatan at two months.p-value: 0.005Wilcoxon (Mann-Whitney)
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).
Time frame: Baseline, 1 month, 2 months
Population: One eye per participant in each Arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New to Meds | Conjunctival Hyperemia Score | Baseline | 4.0 units on a scale | Standard Deviation 2.7 |
| New to Meds | Conjunctival Hyperemia Score | 2 months | 4.0 units on a scale | Standard Deviation 3.5 |
| New to Meds | Conjunctival Hyperemia Score | 1 month | 4.0 units on a scale | Standard Deviation 2.7 |
| Currently on Xalatan | Conjunctival Hyperemia Score | Baseline | 4.6 units on a scale | Standard Deviation 3.3 |
| Currently on Xalatan | Conjunctival Hyperemia Score | 2 months | 5.3 units on a scale | Standard Deviation 3.7 |
| Currently on Xalatan | Conjunctival Hyperemia Score | 1 month | 4.6 units on a scale | Standard Deviation 3.3 |
| Group 2 Xalatan | Conjunctival Hyperemia Score | 1 month | 3.4 units on a scale | Standard Deviation 2.5 |
| Group 2 Xalatan | Conjunctival Hyperemia Score | Baseline | 3.2 units on a scale | Standard Deviation 2.6 |
| Group 2 Xalatan | Conjunctival Hyperemia Score | 2 months | 3.3 units on a scale | Standard Deviation 3.3 |
| Group 2 Travatan Z | Conjunctival Hyperemia Score | Baseline | 3.6 units on a scale | Standard Deviation 3.2 |
| Group 2 Travatan Z | Conjunctival Hyperemia Score | 2 months | 4.0 units on a scale | Standard Deviation 3.8 |
| Group 2 Travatan Z | Conjunctival Hyperemia Score | 1 month | 4.8 units on a scale | Standard Deviation 3.2 |
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).
Time frame: Baseline, 1 month, 2 months
Population: One eye from each patient per arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New to Meds | Corneal Staining Score | 2 months | 1.0 scores on a scale | Standard Deviation 2 |
| New to Meds | Corneal Staining Score | Baseline | 0.7 scores on a scale | Standard Deviation 1 |
| New to Meds | Corneal Staining Score | 1 month | 0.7 scores on a scale | Standard Deviation 1 |
| Currently on Xalatan | Corneal Staining Score | 1 month | 0.8 scores on a scale | Standard Deviation 1 |
| Currently on Xalatan | Corneal Staining Score | Baseline | 0.8 scores on a scale | Standard Deviation 1 |
| Currently on Xalatan | Corneal Staining Score | 2 months | 1.3 scores on a scale | Standard Deviation 1.9 |
| Group 2 Xalatan | Corneal Staining Score | 1 month | 1.3 scores on a scale | Standard Deviation 2 |
| Group 2 Xalatan | Corneal Staining Score | Baseline | 1.0 scores on a scale | Standard Deviation 1.9 |
| Group 2 Xalatan | Corneal Staining Score | 2 months | 1.0 scores on a scale | Standard Deviation 1.5 |
| Group 2 Travatan Z | Corneal Staining Score | Baseline | 1.0 scores on a scale | Standard Deviation 1.8 |
| Group 2 Travatan Z | Corneal Staining Score | 2 months | 1.0 scores on a scale | Standard Deviation 0.9 |
| Group 2 Travatan Z | Corneal Staining Score | 1 month | 1.2 scores on a scale | Standard Deviation 1.6 |
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.
Time frame: Baseline, 1 month, 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New to Meds | Intraocular Pressure | Baseline | 20.9 mmHg | Standard Deviation 7.1 |
| New to Meds | Intraocular Pressure | 1 month | 15.6 mmHg | Standard Deviation 3.8 |
| New to Meds | Intraocular Pressure | 2 months | 14.6 mmHg | Standard Deviation 3.7 |
| Currently on Xalatan | Intraocular Pressure | 2 months | 15.2 mmHg | Standard Deviation 3.8 |
| Currently on Xalatan | Intraocular Pressure | 1 month | 15.5 mmHg | Standard Deviation 3.4 |
| Currently on Xalatan | Intraocular Pressure | Baseline | 20.1 mmHg | Standard Deviation 6.3 |
| Group 2 Xalatan | Intraocular Pressure | Baseline | 14.8 mmHg | Standard Deviation 2.7 |
| Group 2 Xalatan | Intraocular Pressure | 1 month | 15.1 mmHg | Standard Deviation 2.8 |
| Group 2 Xalatan | Intraocular Pressure | 2 months | 14.6 mmHg | Standard Deviation 3.3 |
| Group 2 Travatan Z | Intraocular Pressure | 2 months | 14.3 mmHg | Standard Deviation 3.3 |
| Group 2 Travatan Z | Intraocular Pressure | 1 month | 14.5 mmHg | Standard Deviation 2.8 |
| Group 2 Travatan Z | Intraocular Pressure | Baseline | 15.0 mmHg | Standard Deviation 3.3 |
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.
Time frame: Baseline, 1 month, 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New to Meds | Ocular Surface Disease Index Score | Baseline | 10.8 scores on a scale | Standard Deviation 14.7 |
| New to Meds | Ocular Surface Disease Index Score | 2 months | 11.1 scores on a scale | Standard Deviation 11.9 |
| New to Meds | Ocular Surface Disease Index Score | 1 month | 10.8 scores on a scale | Standard Deviation 14.7 |
| Currently on Xalatan | Ocular Surface Disease Index Score | Baseline | 11.7 scores on a scale | Standard Deviation 14.2 |
| Currently on Xalatan | Ocular Surface Disease Index Score | 2 months | 11.8 scores on a scale | Standard Deviation 11.6 |
| Currently on Xalatan | Ocular Surface Disease Index Score | 1 month | 11.7 scores on a scale | Standard Deviation 14.2 |
| Group 2 Xalatan | Ocular Surface Disease Index Score | 1 month | 7.0 scores on a scale | Standard Deviation 6.9 |
| Group 2 Xalatan | Ocular Surface Disease Index Score | Baseline | 9.8 scores on a scale | Standard Deviation 11.4 |
| Group 2 Xalatan | Ocular Surface Disease Index Score | 2 months | 6.6 scores on a scale | Standard Deviation 8.7 |
| Group 2 Travatan Z | Ocular Surface Disease Index Score | Baseline | 14.2 scores on a scale | Standard Deviation 17.7 |
| Group 2 Travatan Z | Ocular Surface Disease Index Score | 2 months | 11.2 scores on a scale | Standard Deviation 18.3 |
| Group 2 Travatan Z | Ocular Surface Disease Index Score | 1 month | 8.1 scores on a scale | Standard Deviation 7.7 |
Secondary
Tear Production
Tear production, measured by Schirmer test in millimeters
Time frame: Baseline, 1 month, 2 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| New to Meds | Tear Production | 1 month | 21.1 millimeters | Standard Deviation 9.6 |
| New to Meds | Tear Production | 2 months | 23.0 millimeters | Standard Deviation 9.35 |
| New to Meds | Tear Production | Baseline | 22.4 millimeters | Standard Deviation 8.7 |
| Currently on Xalatan | Tear Production | Baseline | 17.1 millimeters | Standard Deviation 9.3 |
| Currently on Xalatan | Tear Production | 1 month | 17.4 millimeters | Standard Deviation 9 |
| Currently on Xalatan | Tear Production | 2 months | 17.4 millimeters | Standard Deviation 9.8 |