Dry Eye
Conditions
Brief summary
Cequa's Onset of Action Trial: an Investigation of CEQUA's Speed of Onset in Improving Ocular Surface Health in Dry Eye Patients
Detailed description
The purpose of this study is to examine the speed of onset of CEQUA ™ in improving the ocular surface among patients with dry eye.
Interventions
Cyclosporine BID in the study eye
Sponsors
Research Insight LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
\*Patients with the following signs: Central or inferior corneal fluorescein staining defined by the Oxford Scale Reduced tear break up time (TBUT) ≤ 10 seconds. * Able to comprehend and sign a statement of informed consent. * Willing and able to complete all required postoperative visits.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in corneal high order aberrations (HOA) | After 7, 14, and 28 days of treatment | Change in corneal HOA |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in corneal staining | After 7, 14, 28 days of treatment | Corneal staining |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in best corrected visual acuity | After 7, 14, and 28 days of treatment | Best corrected visual acuity |
Countries
United States
Outcome results
None listed