Ocular Surface Tolerability Study of Prostaglandin Analogues in Patients With Open-Angle Glaucoma or Ocular Hypertension

NCT01253902 | Completed Phase 4 Results

• 1 other identifier: GMA-LUM-09-014
• Study Type: interventional
• Target: 164
• Locations: 2 countries
• Sites: 2

Brief Summary

This study evaluated the ocular surface tolerability of the prostaglandin analogues bimatoprost ophthalmic solution 0.01% (Lumigan® 0.01%), travoprost ophthalmic solution 0.004% (Travatan Z®) and latanoprost ophthalmic solution 0.005% (Xalatan®) in patients previously treated with Xalatan® who have open-angle glaucoma or ocular hypertension.

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

• Mean Conjunctival Hyperemia at Week 12

  Conjunctival hyperemia was analyzed using the average of the scores of both eyes. Hyperemia is engorgement of the blood vessels (redness) of the bulbar conjunctiva of the eye (the clear membrane covering the white surface of the eye). Hyperemia was graded on a 5 point scale where 0=none (normal), 0.5=trace (trace flush reddish pink), 1=Mild (mild flush reddish color), 2=Moderate (bright red color) and 3=severe (deep bright diffuse redness).

  Week 12

Secondary Outcomes (2)

• Mean Corneal Staining With Fluorescein at Week 12

  Week 12

• Mean Tear Break Up Time (TBUT) at Week 12

  Week 12

Study Arms (3)

bimatoprost ophthalmic solution 0.01%

ACTIVE COMPARATOR

One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.

Drug: bimatoprost ophthalmic solution 0.01%

travoprost ophthalmic solution 0.004%

ACTIVE COMPARATOR

One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.

Drug: travoprost ophthalmic solution 0.004%

latanoprost ophthalmic solution 0.005%

ACTIVE COMPARATOR

One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.

Drug: latanoprost ophthalmic solution 0.005%

Interventions

bimatoprost ophthalmic solution 0.01% DRUG

One drop of bimatoprost ophthalmic solution 0.01% administered to affected eye(s), once daily in the evening for 12 weeks.

Also known as: Lumigan® 0.01%, Lumigan® RC

bimatoprost ophthalmic solution 0.01%

travoprost ophthalmic solution 0.004% DRUG

One drop of travoprost ophthalmic solution 0.004% administered to affected eye(s), once daily in the evening for 12 weeks.

Also known as: Travatan Z®

travoprost ophthalmic solution 0.004%

latanoprost ophthalmic solution 0.005% DRUG

One drop of latanoprost ophthalmic solution 0.005% administered to affected eye(s), once daily in the evening for 12 weeks.

Also known as: Xalatan®

latanoprost ophthalmic solution 0.005%

Eligibility Criteria

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

You may qualify if:

• Diagnosis of ocular hypertension or open-angle glaucoma in at least 1 eye requiring treatment with an anti-glaucoma/ocular hypertensive medication
• Best corrected visual acuity score of 20/100 or better in both eyes
• Females on birth control pills must be on same type of pill and dose for at least 3 month

You may not qualify if:

• Use of Lumigan® 0.01%/Lumigan® RC, Lumigan®, Travatan® or Travatan Z® within 6 months
• History of or active ocular infection/inflammation (eg, uveitis)
• Punctal plug use
• Required use of ocular medications during the study other than study medication (intermittent use of certain types artificial tears acceptable)
• Intraocular surgery or glaucoma laser surgery in study eye(s) within 3 months
• History of corneal refractive laser surgery (eg, LASIK, LASEK) in study eye(s)
• Planned contact lens wear during study

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Rogers, Arkansas, United States

Location

Unknown Facility

Calgary, Alberta, Canada

Location

Related Publications (2)

• Schwartz GF, Hollander DA, Williams JM. Evaluation of eye drop administration technique in patients with glaucoma or ocular hypertension. Curr Med Res Opin. 2013 Nov;29(11):1515-22. doi: 10.1185/03007995.2013.833898. Epub 2013 Sep 5.

  PMID: 24006861 DERIVED

• Crichton AC, Vold S, Williams JM, Hollander DA. Ocular surface tolerability of prostaglandin analogs and prostamides in patients with glaucoma or ocular hypertension. Adv Ther. 2013 Mar;30(3):260-70. doi: 10.1007/s12325-013-0014-7. Epub 2013 Mar 7.

  PMID: 23475405 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

Bimatoprost; Travoprost; Latanoprost

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 6, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 7, 2012
• Results First Posted: November 7, 2012

Record last verified: 2012-10

Locations

US (1); CA (1)