GlaucomaPhase 4NCT00798694
How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
A Phase 4 study testing Xalatan and Travatan Z in people with Glaucoma, run by Wills Eye at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Xalatan and Travatan Z
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Feb 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wills Eye Glaucoma Service
Philadelphia, Pennsylvania, 19107
About this study
Official title: Ocular Surface Changes With Topical Prostaglandin Analog Therapy
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.
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Xalatan, Travatan Z
- Keywords
- glaucoma, impression cytology, ocular surface changes, prostaglandins
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XalatanDrug
Also called prostaglandin analog
one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime
Travatan ZDrug
Also called prostaglandin analog
one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Xalatan; Drug: Travatan Z |
| 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. Receives: Drug: Xalatan; Drug: Travatan Z |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 month, 2 months
Secondary outcomes (5)
Tear Production
Tear production, measured by Schirmer test in millimeters
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline, 1 month, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wills Eye
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, L. Jay Katz MD, Wills Eye
- Investigators
- Leslie J Katz, MD, Principal investigator, Wills Eye Glaucoma Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798694
- Sponsor's protocol ID
- 08-875
- Status last verified
- Jul 2018
- First submitted
- 25 Nov 2008
- Last updated
- 12 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: A manuscript has been published.
Publications
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
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.
PubMed 28617732
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Surface Changes With Topical Prostaglandin Analog Therapy
- ClinicalTrials.gov ID
- NCT00798694
- Acronym / sponsor ID
- 08-875
- Conditions
- Glaucoma
- Keywords
- glaucoma, impression cytology, ocular surface changes, prostaglandins
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Wills EyeUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Nov 2008
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Posted 12 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New to Meds | Other | Drug: Xalatan, Drug: Travatan ZNaive 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 | Drug: Xalatan, Drug: Travatan ZPatients currently on Xalatan at least one month. All patients will receive Xalatan in the right eye and Travatan Z in the left eye. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
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 |
|---|---|---|
| XalatanAlso: prostaglandin analogone drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime | Drug | Currently on Xalatan, New to Meds |
| Travatan ZAlso: prostaglandin analogone drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime | Drug | Currently on Xalatan, New to Meds |
Primary outcome
Change in Tear Break up Time (TBUT)
Time frame: Baseline, 1 month, 2 months
Difference of tear break up time (in seconds, average of 3 measurements) at one and two months after enrollment.
5 secondary outcomes
Tear Production
Time frame: Baseline, 1 month, 2 months
Conjunctival Hyperemia Score
Time frame: Baseline, 1 month, 2 months
Intraocular Pressure
Time frame: Baseline, 1 month, 2 months
Ocular Surface Disease Index Score
Time frame: Baseline, 1 month, 2 months
Corneal Staining Score
Time frame: Baseline, 1 month, 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationGupta 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 publication: PubMed 28617732Rahmatnejad 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.
- Individual participant dataSharing planned: No. A manuscript has been published.
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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.
Leslie J Katz, MD principal investigator
Wills Eye Glaucoma Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xalatan and Travatan Z in people with Glaucoma, run by Wills Eye at 1 site 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 7 inclusion and 10 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 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Change in Tear Break up Time (TBUT) (time frame: Baseline, 1 month, 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00798694, which also lists 2 linked publications.
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 12 Jul 2018.