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

NCT00798694 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 08-875
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

glaucoma; impression cytology; ocular surface changes; prostaglandins

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Tear Production

  Baseline, 1 month, 2 months

• Conjunctival Hyperemia Score

  Baseline, 1 month, 2 months

• Intraocular Pressure

  Baseline, 1 month, 2 months

• Ocular Surface Disease Index Score

  Baseline, 1 month, 2 months

• Corneal Staining Score

  Baseline, 1 month, 2 months

Study Arms (2)

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.

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.

Drug: Xalatan; Drug: Travatan Z

Interventions

Xalatan DRUG

one drop of Xalatan Ophthalmic Solution instilled in right eye at bedtime

Also known as: prostaglandin analog

Currently on Xalatan; New to Meds

Travatan Z DRUG

one drop of Travatan Z Ophthalmic Solution instilled in left eye at bedtime

Also known as: prostaglandin analog

Currently on Xalatan; New to Meds

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wills Eye: lead
• Pfizer: collaborator

Study Sites (1)

Wills Eye Glaucoma Service

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• 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

  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.

  PMID: 28617732 RESULT

MeSH Terms

Conditions

Glaucoma

Interventions

Latanoprost; Prostaglandins, Synthetic; Travoprost

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins F, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Cloprostenol

Limitations and Caveats

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.

Results Point of Contact

• Title: Principal Investigator
• Organization: Wills Eye Hospital

ljaykatz@gmail.com

215-928-3197

Study Officials

• Leslie J Katz, MD

  Wills Eye Glaucoma Service

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Doctors assessing patients were masked to treatment. Patients used open label Xalantan in the right eye and Travatan Z in the left eye.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 25, 2008
• First Posted: November 26, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 12, 2018
• Results First Posted: July 12, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)