Phase 4
Completed N=58
How Similar Are Changes to the Surface of the Eye When Two Different Glaucoma Eye Drops Are Used?
Source: ClinicalTrials.gov NCT00798694 ↗Enrolled (actual)
58
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Change in Tear Break up Time (TBUT) — -0.86; -0.59; -2.00; 0.27 seconds — p=0.005
◆ Published Evidence
Emerging
9citations · ~1 / year
The Effects of Latanoprost With Benzalkonium Chloride Versus Travoprost With SofZia on the Ocular Surface.
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.
Linked Publications
-
The Effects of Latanoprost With Benzalkonium Chloride Versus Travoprost With SofZia on the Ocular Surface.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Tear Break up Time (TBUT) |
-0.86; -0.59; -2.00; 0.27 | 0.005 sig |
| SECONDARY Tear Production |
22.4; 17.1; 21.1; 17.4; 23.0; 17.4 | — |
| SECONDARY Conjunctival Hyperemia Score |
4.0; 4.6; 3.2; 3.6; 4.0; 4.6 | — |
| SECONDARY Intraocular Pressure |
20.9; 20.1; 14.8; 15.0; 15.6; 15.5 | — |
| SECONDARY Ocular Surface Disease Index Score |
10.8; 11.7; 9.8; 14.2; 10.8; 11.7 | — |
| SECONDARY Corneal Staining Score |
0.7; 0.8; 1.0; 1.0; 0.7; 0.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT00798694) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.