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®

Edward Holland, MD

Status and phase: Withdrawn; Phase 4

Conditions: Dry Eye Disease

Treatments: Drug: Loteprednol etabonate; Drug: Artificial Tears; Drug: Restasis

Study type: Interventional

Funder types: Other

Identifiers

NCT02028312

CEI.HER-002

Details and patient eligibility

About

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.

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

Loteprednol etabonate + Restasis

Active Comparator group

Description:

Loteprednol Etabonate Ophthalmic Gel 0.5%, BID 30 days Restasis, BID 45 days

Treatment:

Drug: Restasis

Drug: Loteprednol etabonate

Artificial Tears + Restasis

Placebo Comparator group

Description:

Artificial Tears, BID 30 days Restasis, BID 45 days

Treatment:

Drug: Restasis

Drug: Artificial Tears