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How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?

Primary Purpose

Glaucoma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Xalatan
Travatan Z
Sponsored by
Wills Eye
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, impression cytology, ocular surface changes, prostaglandins

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wills Eye Glaucoma Service

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

New to Meds

Currently on Xalatan

Arm Description

Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.

Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Tear Production
Tear production, measured by Schirmer test in millimeters
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).
Intraocular Pressure
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
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
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).

Full Information

First Posted
November 25, 2008
Last Updated
July 11, 2018
Sponsor
Wills Eye
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00798694
Brief Title
How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
Official Title
Ocular Surface Changes With Topical Prostaglandin Analog Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wills Eye
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, impression cytology, ocular surface changes, prostaglandins

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Non-Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
New to Meds
Arm Type
Other
Arm Description
Naive to glaucoma therapy medical or surgical. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Arm Title
Currently on Xalatan
Arm Type
Other
Arm Description
Patients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye.
Intervention Type
Drug
Intervention Name(s)
Xalatan
Other Intervention Name(s)
prostaglandin analog
Intervention Description
one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Intervention Type
Drug
Intervention Name(s)
Travatan Z
Other Intervention Name(s)
prostaglandin analog
Intervention Description
one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
Primary Outcome Measure Information:
Title
Change in Tear Break up Time (TBUT)
Description
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
Secondary Outcome Measure Information:
Title
Tear Production
Description
Tear production, measured by Schirmer test in millimeters
Time Frame
Baseline, 1 month, 2 months
Title
Conjunctival Hyperemia Score
Description
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
Title
Intraocular Pressure
Description
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
Title
Ocular Surface Disease Index Score
Description
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
Title
Corneal Staining Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie J Katz, MD
Organizational Affiliation
Wills Eye Glaucoma Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wills Eye Glaucoma Service
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
A manuscript has been published.
Citations:
Citation
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
Results Reference
result
PubMed Identifier
28617732
Citation
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.
Results Reference
result

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How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?

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