Corneal Tear Film Imaging of the Cornea Before and After Restasis Therapy

NCT03403023 | Unknown

• 1 other identifier: 0178-16-MMC
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Dry Eye Syndrome (DES) is a disease affects the production and stability of the tear film, leading to vision disturbances and a major decrease in quality of life. The most recommended treatment for moderate-severe DES today which failed conservative therapy with lubricating eye drops is topical Cyclosporine 0.05% (Restasis®). The Tear Film Imager (TFI) is a novel imaging modality designed for visualization of the individual tear film layers up to a resolution of 0.1 micrometers, a property not enabled by any other imaging modality for this indication to date. In this study we wish to assess the effects of topical Cyclosporine 0.05% on the tear film using the TFI. In our previous study we found this modality yields high resolution images of the tear film, yielding significant differences between healthy and diseased (DES) eyes. We believe the TFI will improve quality of assessment and follow-up of DES patients, allowing more effective diagnosis and treatment of this disease in the future.

Conditions

Dry Eye Syndrome; Tear Film Insufficiency

Keywords

Dry Eye Disease; Tear Film Imager; tear film; Cyclosporine; dry eye syndrome; keratoconjunctivitis sicca

Outcome Measures

Primary Outcomes (1)

• Tear Film changes

  The tear film layers are imaged by the TFI before and after Restasis therapy. We will compare the differences in the tear film image in eyes before after therapy and see if there are significant differences between them.

  3 months

Study Arms (1)

DES treated patients

EXPERIMENTAL

This single group of patients is imaged by the Tear Film Imager (TFI) device before and after treatment with Restasis, the treatment indicated for their condition.

Device: Tear Film Imager; Drug: Restasis

Interventions

Tear Film Imager DEVICE

The TFI is an imaging device based on standard camera that uses white light to image the tear film in an ultra high resolution. DES patients in this study will be imaged before and 3 months after initiation of treatment with Restasis (the treatment indicated for their condition).

Also known as: TFI

DES treated patients

Restasis DRUG

Restasis therapy is given to all of the patients as indicated for moderate-severe DES. TFI imaging is performed before and 3 months after initiation of therapy.

Also known as: Ophthalmic Cyclosporine A 0.05%

DES treated patients

Eligibility Criteria

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

You may qualify if:

• Non-pregnant adults, excluding individuals with legal misjudgement, with moderate-severe Dry Eye Syndrome (DES).
• Moderate-severe DES will be defined by the following criteria:
• Schirmer test without anesthesia \< 7 mm / 5 seconds AND
• One or more of the following (a-c):
• OSDI score \>20
• Positive fluorescein staining (staining degree 1 in one of the eyes, where 0=no staining, 3=very significant staining)
• Tear Break-Up Time (TBUT) \<= 8 seconds in one of the eyes.

You may not qualify if:

• Disagreement to participate in the trial
• Stevens-Johnson syndrome
• Post-burn ocular injury
• Chronic ocular diseases other that DES requiring topical treatment
• Ocular herpes simplex disease
• Persistent ocular inflammation or infection
• Active blepharitis or blepharitis defined more severe than mild
• Intraocular procedure less than 3 months prior to participation in the trial
• Punctal plugs in one of the eyes
• Subepithelial corneal scars
• Neurotrophic cornea
• Contact lens use in the 3 months prior to participation in the trial
• Current topical treatment with Cyclosporine A
• Previous refractive surgery
• Keratoconus patients

Sponsors & Collaborators

• Meir Medical Center: lead

Related Publications (2)

• Stonecipher K, Perry HD, Gross RH, Kerney DL. The impact of topical cyclosporine A emulsion 0.05% on the outcomes of patients with keratoconjunctivitis sicca. Curr Med Res Opin. 2005 Jul;21(7):1057-63. doi: 10.1185/030079905X50615.

  PMID: 16004673 BACKGROUND

• Pflugfelder SC. Anti-inflammatory therapy of dry eye. Ocul Surf. 2003 Jan;1(1):31-6. doi: 10.1016/s1542-0124(12)70005-8.

  PMID: 17075627 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes; Xerophthalmia; Keratoconjunctivitis Sicca

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Fani Segev, M.D.

  Ophthalmology department, MeirMC, Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yael Yohai Patael, M.D.

CONTACT

+972544914544; yael.yohai@gmail.com

Fani Segev, M.D.

CONTACT

+972526995044; fsegev@netvision.net.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: A single group of patients with DES is imaged before and after treatment with Restasis, a medication which is already FDA approved for this indication.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 18, 2018
• Study Start: January 30, 2018
• Primary Completion: May 30, 2018
• Study Completion: December 30, 2018
• Last Updated: January 18, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share