A Phase IV, Randomized, Parallel Group, Investigator-Masked Evaluation of the Effect of Loteprednol Etabonate Ophthalmic Gel 0.5% on the Initiation of Dry Eye Treatment With Restasis®

Phase 4

Withdrawn

• Conditions: Dry Eye Disease
• Interventions: Drug: Loteprednol etabonate; Drug: Artificial Tears; Drug: Restasis

• Registration Number: NCT02028312
• Lead Sponsor: Edward Holland, MD

Brief Summary

A pilot study to evaluate the impact of Lotemax® Gel (loteprednol etabonate ophthalmic gel 0.5%) on the initiation of Restasis® (cyclosporine ophthalmic emulsion 0.05%) therapy in subjects with dry eye.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-03
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18
• Primary Completion: 2016-02
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Provide written informed consent prior to any study-related procedures and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.

2. Are between the ages of 21 and 80 inclusive.

3. Have not worn contact lenses for at least 1 month prior to the study and agrees not to wear contact lenses during the study.

4. Have been on stable oral medications for 1 month prior to the study.

5. Are in generally good and stable overall health.

6. Are a woman of child bearing potential (WOCBP) who is not pregnant or lactating and not sexually active (i.e. abstinent) at Visit 1 and willing to remain so through Visit 4. Alternatively, a WOCBP who is not abstinent must have been using an acceptable method of birth control for at least 4 weeks prior to Visit 1 and throughout the study.

7. Are women who have undergone one of the following sterilization procedures at least 1 month prior to Visit 1:

   1. Bilateral tubal ligation
   2. Hysterectomy
   3. Hysterectomy with unilateral or bilateral oophorectomy.
   4. Bilateral oophorectomy

8. Are likely to comply with the eye drop regime, study guidelines, and study visits.

Exclusion Criteria

1. Have a history of Stevens-Johnson Syndrome or ocular pemphigoid.
2. Have had punctual plugs inserted or removed; or punctual cautery 3 months prior to Visit 1/Screening and Baseline Visit and throughout the study.
3. Have had intra-ocular surgery within 6 months prior to the Visit 1/Screening and Baseline Visit.
4. Have a history of liver disease.
5. Be pregnant or lactating.
6. Have severe clinical vitamin deficiencies or a history of vitamin overdose.
7. Have a highly variable vitamin intake.
8. Wear contact lenses.
9. Have unstable use of systemic or topical medications known to create dry eye.
10. Have corneal pathology, which could, of itself, cause an ocular surface disorder.
11. Have used glaucoma medications, topical or oral within 30 days of Visit 1/Screening and Baseline Visit.
12. Have unstable diabetes mellitus.
13. Have an allergy or sensitivity to Lotemax® Gel, Restasis®, or non-preservative artificial tears.
14. Have used topical steroids or Restasis® within 1 month prior to the Screening and Baseline Visit and throughout the study, except the study medication provided per the protocol.
15. Have a condition for which steroid use would be contraindicated (e.g. viral infection).
16. Use other topical ocular agents other than tear replacements within 1 week prior to the Screening and Baseline Visit and throughout the study.
17. Have been exposed to an investigational drug within the preceding 30 days.
18. In the opinion of the investigator or study coordinator, be unwilling or unable to comply with the study protocol or unable to successfully instill eye drops.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Loteprednol etabonate + Restasis	Loteprednol etabonate	Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days
Artificial Tears + Restasis	Artificial Tears	Artificial Tears, BID 30 days Restasis, BID 45 days
Loteprednol etabonate + Restasis	Restasis	Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days
Artificial Tears + Restasis	Restasis	Artificial Tears, BID 30 days Restasis, BID 45 days

Primary Outcome Measures

Name	Time	Method
Fluorescein corneal staining scores	60 Days

Secondary Outcome Measures

Name	Time	Method
Lissamine green conjunctival staining	60 Days

Trial Locations

Locations (1)

Cincinnati Eye Institute; 🇺🇸 Edgewood, Kentucky, United States