Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens

Vision Correction Clinical Trial

Official title:

Three Month Clinical Evaluation of the Contamac 74% Silicone Hydrogel Contact Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01197859
• Other study ID #: CCSH-1901
• Status: Completed
• Phase: N/A
• Start date: August 2008
• Est. completion date: February 2009

Study information

• Verified date: August 2020
• Source: Contamac Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical performance of the contamac silicone hydrogel contact lens with a predicate device (Cooper Vision Biofinity).

Description:

The purpose of this study is to evaluate the clinical performance of the Contamac lens in comparison with a currently marketed silicone hydrogel: Biofinity® (CooperVision). This is a 3-month, open-label, bilateral, parallel group, randomised, daily wear study. Approx. two-thirds of the subjects will wear the Contamac Silicone Hydrogel lens in both eyes while the other third will wear control lenses.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• existing contact lens wearer

• read and signed statement of informed consent

• has clear central cornea

• requires spherical distance correction

Exclusion Criteria:

• has worn RGP contact lenses within the last 30 days

• is using any ocular medication

• has had refractive surgery

• has an infectious disease

• is pregnant or lactating

• is participating in another clinical research study

Related Conditions & MeSH terms

• Vision Correction

Intervention

Device:
• Definitive Contact Lens
Daily wear contact lens
• Biofinity
Daily wear contact lens

Locations

Country	Name	City	State
United Kingdom	Vision Care Research	Farnham	Surry

Sponsors (1)

Lead Sponsor	Collaborator
Contamac Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess performance variables as compared to the predicate device during follow-up visits to demonstrate safety and efficacy.	The clinical study will assess the following performance variables as compared to the predicate device during 5 follow-up visits over a 3 month period to demonstrate safety and efficacy: Sphere-cyl Refraction and VA, Keratometry, Comfort, Handling, Symptoms, Over-Refraction and VA, Lens Fit, Lens Deposits, and Slit Lamp Findings.	3 months