Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness

NCT03686878 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: LF5-CLD
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The most common reason for contact lens discontinuation is contact lens discomfort. The investigators believe that inflammation plays a role in contact lens discomfort and the use of lifitegrast 5% ophthalmic solution may reduce end of the day contact lens discomfort. This study will enroll 21 contact lens users who will be receiving lifitegrast 5% ophthalmic solution and monitor the contact lens discomfort for a 8 week period while.

Conditions

Contact Lens; Contact Lens Discomfort; Contact Lens Dryness

Keywords

Keratoconjunctivitis Sicca; Dry Eye Disease; Eye Dryness

Outcome Measures

Primary Outcomes (2)

• Change in CLDEQ-8 scores as reported by study participants

  measured changes in CLDEQ-8 scores as reported by study participants

  baseline to week 8

• Lisamine (corneal, conjunctiva) staining scores

  Lisamine score using the Oxford-Schema scoring

  baseline to week 8

Secondary Outcomes (1)

• Visual Acuity

  Baseline to week 8

Study Arms (1)

Intervention Group

EXPERIMENTAL

Lifitegrast 5% ophthalmic solution group

Drug: Lifitegrast

Interventions

Lifitegrast DRUG

Lifitegrast used twice a day

Intervention Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Agree with study protocol
• Provide Informed Consent
• Age 21 or over
• Previous 10 months history of self-assessed comfortable wear samfilcon A contact lenses

You may not qualify if:

• Unable or unwilling to comply with study protocol
• Unable of unwilling to provide Informed consent
• Self-reported symptomatic intolerance of contact lenses
• History of an active anterior segment, eyelids, eyelashes, corneal or conjunctival pathology, ongoing ocular infection, inflammation or any other ocular problem that would require management with additional topical ophthalmic medications.
• Have had a history of corneal surgery (corneal transplants, LASIK, PRK).

Sponsors & Collaborators

• EV Clinical Trials: lead

Study Sites (1)

Eye & Vision

Richardson, Texas, 75082, United States

Location

Related Publications (3)

• Efron N. Contact lens wear is intrinsically inflammatory. Clin Exp Optom. 2017 Jan;100(1):3-19. doi: 10.1111/cxo.12487. Epub 2016 Nov 2.

  PMID: 27806431 BACKGROUND

• Godin MR, Gupta PK. Lifitegrast ophthalmic solution in the treatment of signs and symptoms of dry eye disease: design, development, and place in therapy. Clin Ophthalmol. 2017 May 22;11:951-957. doi: 10.2147/OPTH.S117188. eCollection 2017.

  PMID: 28579745 BACKGROUND

• Nichols JJ, Willcox MD, Bron AJ, Belmonte C, Ciolino JB, Craig JP, Dogru M, Foulks GN, Jones L, Nelson JD, Nichols KK, Purslow C, Schaumberg DA, Stapleton F, Sullivan DA; members of the TFOS International Workshop on Contact Lens Discomfort. The TFOS International Workshop on Contact Lens Discomfort: executive summary. Invest Ophthalmol Vis Sci. 2013 Oct 18;54(11):TFOS7-TFOS13. doi: 10.1167/iovs.13-13212. No abstract available.

  PMID: 24058135 BACKGROUND

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes; Xerophthalmia

Interventions

lifitegrast

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2018
• First Posted: September 27, 2018
• Study Start: December 16, 2016
• Primary Completion: July 14, 2017
• Study Completion: July 14, 2017
• Last Updated: September 28, 2018

Record last verified: 2018-09

Locations

US (1)