Clinical Trials Logo
  1. Home
  2. Dry Eye Syndromes
  3. NCT00284999
  4. Details
NCT00284999 Clinical Trial

Soothe Versus Refresh

Dry Eye Syndromes Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00284999
Other study ID # PRN 05-034
Secondary ID
Status Completed
Phase Phase 4
First received January 31, 2006
Last updated August 21, 2006
Est. completion date August 2006

Study information
Verified date August 2006
Source Pharmaceutical Research Network
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

To determine the ocular efficacy and safety of Soothe and Refresh Tears.

Recruitment information / eligibility
Status Completed
Enrollment 33
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adults with a diagnosis of dry eyes

- Schirmer's with anesthesia grade between 1-7 mm inclusive after five (5) minutes in at least one eye

- a corneal staining grade of greater than or equal to 2 (scale 0-4) in the same qualifying eye as the Schirmer’s test

Exclusion Criteria:

- contact lens use during the active treatment periods of the trial

- history of Sjogren's Syndrome

- temporary punctal occlusion that is still effective

- the current or anticipated use during the study of punctual plugs

- current treatment with Restasis

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Soothe

• Refresh Tears

Locations
Country Name City State
United States Coastal Research Associates, LLC Atlanta Georgia
United States Mount Sinai School of Medicine New York New York
United States Michigan Cornea Associates Southfield Michigan

Sponsors (1)
Lead Sponsor Collaborator
Pharmaceutical Research Network

Country where clinical trial is conducted

United States, 

See also
  Status Clinical Trial Phase
Active, not recruiting NCT04425551 - Effect of Micropulse Laser on Dry Eye Disease Due to Meibomian Gland Dysfunction N/A
Not yet recruiting NCT06379685 - Study to Evaluate the Safety and Tolerability of PRO-190 Ophthalmic Solution Compared to Systane Ultra® on the Ocular Surface. Phase 1
Recruiting NCT04701086 - 3 Month Study of Cationorm Pro Versus Vismed in Adults With Dry Eye Disease Related to Keratitis or Keratoconjunctivitis N/A
Active, not recruiting NCT03697876 - Safety and Tolerability of the Ophthalmic Gel PRO-165 Versus Artelac® Nightime Gel Phase 1
Terminated NCT02815293 - Topical Ophthalmic AGN-195263 for the Treatment of Evaporative Dry Eye Phase 3
Completed NCT02910713 - Evaluation of Dry Eye Symptoms in CAE With Application of Intranasal Neurostimulation N/A
Completed NCT04104997 - A Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of GLH8NDE After Single and Mutiple Ocular Administrations in Healthy Korean and Caucasian Volunteers Phase 1
Recruiting NCT02595606 - 0.3% Sodium Hyaluronate in the Treatment of Dry Eye of Diabetic Patients Phase 4
Completed NCT01711424 - An Observational Study of OPTIVE PLUS® for the Treatment of Dry Eye Disease N/A
Completed NCT01015209 - Safety and Tolerability of Chitosan-N-acetylcysteine Eye Drops in Healthy Young Volunteers Phase 1
Completed NCT01202747 - Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction Phase 2/Phase 3
Completed NCT00969280 - Acupuncture for Dry Eye Syndrome Phase 3
Completed NCT00739713 - Effects of Sea Buckthorn Oil on Dry Eye N/A
Completed NCT00756678 - Efficacy and Acceptability of Two Lubricant Eye Drops Phase 4
Completed NCT01496482 - Comparison of Evaporimetry With the Established Methods of Tear Film Measurement N/A
Completed NCT00370747 - Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome Phase 2
Completed NCT00349440 - Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy Phase 4
Completed NCT05162261 - to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction N/A
Completed NCT02871440 - A Two Comparator, Controlled Phase 3 Study in Patients With and Without Evaporative Dry Eye Phase 3
Completed NCT05042960 - Computer Screen Properties Study N/A