Elsevier

Ophthalmology

Volume 108, Issue 2, February 2001, Pages 264-271
Ophthalmology

Comparison of the corneal effects of latanoprost, fixed combination latanoprost–timolol, and timolol: A double-masked, randomized, one-year study

Presented in part at the American Academy of Ophthalmology Annual Meeting, October 1999, Orlando, Florida.
https://doi.org/10.1016/S0161-6420(00)00531-5Get rights and content

Abstract

Objective

To compare the long-term effects on corneal endothelial cell density and corneal thickness of latanoprost and the fixed combination latanoprost–timolol to timolol.

Design

Double-masked, randomized, prospective, multicenter clinical trial.

Participants

Three hundred sixty-nine subjects with bilateral ocular hypertension or open-angle glaucoma who had a baseline central corneal endothelial cell density of at least 1500 cells/mm2, central corneal thickness of less than 0.68 mm, no corneal pathologic condition on slit-lamp examination, and intraocular pressure of less than 22 mmHg after a 3-week run-in on timolol, 0.5%, once daily were included.

Intervention

Subjects were randomly assigned to treatment with latanoprost 0.005% (n = 127), fixed-combination latanoprost 0.005%–timolol 0.5% (FC, n = 116), or timolol 0.5% (n = 126) one drop, once daily in the morning for 1 year. All subjects were treated in both eyes. Specular microscopy and ultrasonic pachymetry were performed before treatment, and after 6 and 12 months of treatment.

Main outcome measures

Mean percent change in central endothelial cell density and central corneal thickness after 1 year of treatment.

Results

For both corneal endothelial cell density and corneal thickness, the mean percent changes from baseline were similar in all three treatment groups. Mean percent endothelial cell change at 1 year from baseline for latanoprost, FC, and timolol was 0.3 ± 2.2%, 0.1 ± 1.8%, 0.0 ± 2.5% (mean ± standard deviation; 95% confidence interval: latanoprost vs timolol −0.2–1.0; FC vs timolol −0.4–0.7) and mean percent change in corneal thickness was −1.1 ± 2.5%, −1.0 ± 2.0%, 0.2 ± 3.1%, respectively.

Conclusions

Latanoprost and FC are equivalent to timolol regarding long-term corneal effects after 1 year of treatment.

Section snippets

Subjects and methods

The study was a parallel, randomized, double-masked, active-controlled, 1-year multicenter trial conducted at 22 sites throughout the United States. The study protocol and amendments were approved by an institutional review board at each study center. The study was performed in accordance with the ethical principles as described in the Declaration of Helsinki. Before enrollment subjects received information regarding the study, and written informed consent was obtained from each subject.

Results

Three hundred sixty-nine subjects with a mean age of 61 years were enrolled in the study: 127 in the latanoprost group, 116 in the FC group, and 126 in the timolol group (Table 1). The subjects were predominantly white (73%), with an equal number of men and women. The groups did not differ regarding age, gender, race, or baseline IOP. The baseline central endothelial cell density and corneal thickness were similar among the three groups. In 61% of subjects the diagnosis was primary open-angle

Discussion

Latanoprost has proven to be a safe and effective agent for lowering IOP in the management of ocular hypertension and open-angle glaucoma.1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 However, the drug has manifested external (eyelash darkening, thickening, and lengthening) and anterior segment (iridial pigmentation) side effects. A few cases of herpes simplex virus keratitis during latanoprost treatment have been reported, but the role of latanoprost, if any, is still unknown.19, 20, 21, 22 A short-term

Latanoprost corneal effects study group

  • John Burchfield, Rochester, NY

  • Claude Burgoyne, New Orleans, LA

  • Edward Burney, Cleveland, OH

  • Harvey DuBiner, Morrow, GA

  • Marvin Greenberg, Tamarac, FL

  • Ronald Gross, Houston, TX

  • Ramel Hemady, Baltimore, MD

  • Phillip Hessberg, Grosse Pointe Park, MI

  • David Karp, Louisville, KY

  • Michael Kottler, Salt Lake City, UT

  • Theodore Krupin, Chicago, IL

  • Sayoko Moroi, Ann Arbor, MI

  • Robert Noecker, Tucson, AZ

  • Charles Ostrov, Minneapolis, MN

  • Joel Schuman, Boston, MA

  • Elizabeth Sharpe, Mount Pleasant, SC

  • Mark Sherwood, Gainesville, FL

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    Supported by Pharmacia Corporation, Uppsala, Sweden, and in part by the Ohio Lions Eye Research Foundation, Columbus, Ohio, and Research to Prevent Blindness, New York, New York.

    1

    Gina Eriksson and Lisa Osterling were employees of Pharmacia Corporation. The other authors have no proprietary interest in latanoprost or Pharmacia. Ms. Eriksson is now with Quintiles AB, Uppsala, Sweden.

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