Status:
COMPLETED
Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization
Lead Sponsor:
Research Insight LLC
Conditions:
Dry Eye
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The CLEAN Study: Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization-A Prospective Cohort Study of Combination Therapy in the Treatment of Dry Eye
Detailed Description
Thirty million people in the US are thought to suffer from dry eye. Patients with this condition manifest with ocular surface disruption such as corneal fluorescein staining and reduced tear breakup t...
Eligibility Criteria
Inclusion
- Patients over age 18 with the following signs:
- i. Central or inferior corneal fluorescein staining defined by the Oxford Scale ii. Reduced tear break up time (TBUT) ≤ 10 seconds.
- Able to comprehend and sign a statement of informed consent.
- Patients willing to take an electronic survey about their tolerability of either study medication.
- Willing and able to complete all required postoperative visits.
Exclusion
- Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
- Clinically significant ocular trauma.
- Active ocular Herpes simplex or Herpes Zoster infection
- Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
- Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
- Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the study findings.
- Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
- Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
- Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
- Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
- Participation in this trial in the same patient's fellow eye
- Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
Key Trial Info
Start Date :
June 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 21 2022
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT05322148
Start Date
June 3 2022
End Date
November 21 2022
Last Update
January 4 2023
Active Locations (3)
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1
Inland Eye Specialists
Hemet, California, United States, 92545
2
Harvard Eye Associates
Laguna Hills, California, United States, 92653
3
Cleveland Eye Clinic
Brecksville, Ohio, United States, 44141